ScienceMedic
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
592 others
IIa
93/42
EUDAMED record
Report an error
Respironics FDA
EU representative : Philips Medical Systems Nederland B.V. (Netherlands) and 1 other
United States
(10) Bacterial/Viral Filter 1135776 93/42 (10) Circuit,Disp,15mm,Non-Htd,Dual Limb 1127307 93/42 (10) Circuit,Disp,22mm,Non-Htd,Active 1132344 93/42 (10) Circuit,Disp,22mm,Non-Htd,Dual Limb 1127306 93/42 (10) Disposable Active Exhalation Valve 1131661 93/42 701 others 4LXTB,6IN TRACH 15MM TAPER,CE 1004968 93/42 Active Exhalation Device Kit 1065659 93/42 Active Exhalation Device with PAP 1053716 93/42 Adult Invasive Passive Disposable Non-Heated Wire Circuit 1069443 93/42 Adult Non-Invasive Passive Disposable Non-Heated Circuit 1069467 93/42 Aeris EVO 93/42 AW CT Angelini 152PO17433 Pkg Scorer 93/42 AW CT Immusoft MT2018-18 Pkg Scorer 93/42 AW CT Janssen 42847922MDD1005 Scorer 93/42 AW CT Ultragenyx UX701-CL001 Pkg Scorer 93/42 BeLife 40 Pro SPX3100S19 93/42 BiPAP A40 Pro AR ARX3100S19 93/42 BiPAP A40 Pro BR BRX3100S18 93/42 BiPAP A40 Pro Titration Rental Program AU RAUX3100S19 93/42 BiPAP A40 Pro Titration Rental Program BL RBLX3100S19 93/42 BiPAP A40 Pro Titration Rental Program BR RBRX3100S19 93/42 BiPAP A40 Pro Titration Rental Program CA RCAX3100S12 93/42 BiPAP A40 Pro Titration Rental Program DE RDEX3100S13 93/42 BiPAP A40 Pro Titration Rental Program EE REEX3100S19 93/42 BiPAP A40 Pro Titration Rental Program ES RESX3100S19 93/42 BiPAP A40 Pro Titration Rental Program FR RFRX3100S19 93/42 BiPAP A40 Pro Titration Rental Program GB RGBX3100S19 93/42 BiPAP A40 Pro Titration Rental Program IN RINX3100S19 93/42 BiPAP A40 Pro Titration Rental Program IT RITX3100S21 93/42 BiPAP A40 Pro Titration Rental Program ND RNDX3100S19 93/42 BiPAP A40 Pro, AU AUX3100S19 93/42 BiPAP A40 Pro, BL BLX3100S19 93/42 BiPAP A40 Pro, CA CAX3100S12 93/42 BiPAP A40 Pro, CA w/Heated Tube Humid CAX3100T12 93/42 BiPAP A40 Pro, DE DEX3100S13 93/42 BiPAP A40 Pro, EE EEX3100S19 93/42 BiPAP A40 Pro, ES ESX3100S19 93/42 BiPAP A40 Pro, ES w/Heated Humidifier ESX3100H19 93/42 BiPAP A40 Pro, ES w/Heated Tube Humid ESX3100T19 93/42 BiPAP A40 Pro, FR FRX3100S14 93/42 BiPAP A40 Pro, FR w/Heated Humidifier FRX3100H14 93/42 BiPAP A40 Pro, FR w/Heated Tube Humid FRX3100T14 93/42 BiPAP A40 Pro, IA IAX3100S19 93/42 BiPAP A40 Pro, IA w/Heated Humidifier IAX3100H19 93/42 BiPAP A40 Pro, IA w/Heated Tube Humid IAX3100T19 93/42 BiPAP A40 Pro, Intl INX3100S19 93/42 BiPAP A40 Pro, Intl w/Heated Humidifier INX3100H19 93/42 BiPAP A40 Pro, Intl w/Heated Tube Humid INX3100T19 93/42 BiPAP A40 Pro, IT ITX3100S21 93/42 BiPAP A40 Pro, IT w/Heated Humidifier ITX3100H21 93/42 BiPAP A40 Pro, IT w/Heated Tube Humid ITX3100T21 93/42 BiPAP A40 Pro, ND NDX3100S19 93/42 BiPAP A40 Pro, UK GBX3100S19 93/42 BiPAP A40 Pro, UK w/Heated Humidifier GBX3100H19 93/42 BiPAP A40 Pro, UK w/Heated Tube Humid GBX3100T19 93/42 BiPAP A40 Sapio Belife 93/42 BiPAP Auto BiFlex, System One 60 Series, ES REMstar System (60 Series) 93/42 BiPAP Disposable Circuit, Box/10 312107 93/42 Circuit Filter DEP w/FEP Filter 10PK INTL Single Use Filtered Exhalation Port Circuit 93/42 Circuit Filter DEP w/FEP Filter Single, Intl 1073949 93/42 Circuit Filter DEP w/FEP Single, Intl 1073948 93/42 Circuit, DEP w/FEP, INTL, 10 Pack 1069210 93/42 Circuit, Disposable, 15mm, Non-Heated, Passive 1132339 93/42 Circuit, Disposable, 22mm, Adult, Non-Heated Passive 1132340 93/42 CoughAssist E70 Accessories CA70 SERIES,CIRCUIT,ADULT LG.,6FT 93/42 Disp Ext Flow Sensor,Adult/Ped, 10 pk 1146497 93/42 Disposable Adult Active Circuit no H20 Trap 20 pk 1073232 93/42 Disposable Adult Active Circuit no H2O Trap 1073223 93/42 Disposable Adult Passive Circuit no H20 Trap 20 pk 1073236 93/42 Disposable Adult Passve Circuit no H2O Trap 1073228 93/42 Disposable Ext Flow Sensor,Ped/Inf, 10pk 1146558 93/42 Disposable Pediatric Active Circuit with H20 Trap 20 pk 1073229 93/42 Disposable Pediatric Circuit with H20 Trap 1073220 93/42 Disposable Pediatric Passive Circuit with H20 Trap 20 pk 1073233 93/42 Disposable Pediatric Passive Circuit with H2O Trap 1073224 93/42 Disposable Swivel Passive Exhalation Port 1139909 93/42 Dorma 200 w/Humid, INTL 93/42 Dorma 200, INTL 93/42 Dorma 500 Auto, w/ Humid, DE REMstar System (60 Series) 93/42 DreamSt BiPAP AVAPS 30 AE w/HTD Humid, No Btooth, INTL INX1131H19 93/42 DreamSt BiPAP AVAPS30 w/Humid, AAM,VitalAire,Vitalvent VTX1130H24 93/42 DreamSt BiPAPAVAPS30, w/Humid MedicAir, RespiComfort MDX1130H25 93/42 DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, ES 93/42 DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, IT 93/42 DreamStation 2 Auto CPAP Advanced Humid/P Flex/Cell/BT, FR FRX521H14C 93/42 DreamStation 2 Auto CPAP Advanced Humidifier/Bluetooth® only, DE 93/42 DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, EE 93/42 DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, ND 93/42 DreamStation 2 Auto CPAP Advanced w/Humidifier/Cell/Bluetooth, DE DreamStation 2 Advanced CPAP/Auto CPAP 93/42 DreamStation 2 Auto CPAP Humid/Cell/BT, IT 93/42 DreamStation 2 Auto CPAP w/ Humidifier/Cell/Bluetooth, EE DreamStation 2 CPAP/Auto CPAP 93/42 DreamStation 2 CPAP Advanced Humid/BT only, EU 93/42 DreamStation 2 CPAP Advanced Humid/Cell/BT, ES 93/42 DreamStation 2 CPAP Advanced Humid/Cell/BT, GB 93/42 DreamStation 2 CPAP AdvancedHumid/Cell/BT, EU 93/42 DreamStation 2 CPAP w/ Humidifier/Cell/ Bluetooth, EE 93/42 DreamStation 2 CPAP w/Humidifier/Bluetooth only, ES DreamStation 2 CPAP/Auto CPAP 93/42 DreamStation Atuo CPAP w/Cell, ND NDX500S15C 93/42 DREAMSTATION AUTO BIPAP W/HUMID Cell LA LAX700H15C 93/42 DreamStation Auto BiPAP w/Humid, w/H Tube, AU AUX700T15 93/42 DreamStation Auto BiPAP w/Humid, w/H Tube, INTL INX700T15 93/42 DreamStation Auto BiPAP w/Humid, w/H Tube, LA LAX700T15 93/42 DreamStation Auto BiPAP w/Humid, w/H Tube, w/Cell, AU AUX700T15C 93/42 DreamStation Auto BiPAP with Humidifier, AR ARX700H15 93/42 DreamStation Auto BiPAP with Humidifier, AU AUX700H15 93/42 DreamStation Auto BiPAP with Humidifier, BL BLX700H15 93/42 DreamStation Auto BiPAP with Humidifier, EE EEX700H15 93/42 DreamStation Auto BiPAP with Humidifier, ES ESX700H15 93/42 DreamStation Auto BiPAP with Humidifier, EU EUX700H15 93/42 DreamStation Auto BiPAP with Humidifier, GB GBX700H15 93/42 DreamStation Auto BiPAP with Humidifier, INTL INX700H15 93/42 DreamStation Auto BiPAP with Humidifier, ND NDX700H15 93/42 DreamStation Auto BiPAP with Humidifier, TR TRX700H15 93/42 DreamStation Auto BiPAP, AR ARX700S15 93/42 DreamStation Auto BiPAP, AU AUX700S15 93/42 DreamStation Auto BiPAP, BL BLX700S15 93/42 DreamStation Auto BiPAP, DE DEX700S13 93/42 DreamStation Auto BiPAP, EE EEX700S15 93/42 DreamStation Auto BiPAP, ES ESX700S15 93/42 DreamStation Auto BiPAP, FR FRX700S14 93/42 DreamStation Auto BiPAP, GB GBX700S15 93/42 DreamStation Auto BiPAP, GB Rental RGBX700S15 93/42 DreamStation Auto BiPAP, INTL INX700S15 93/42 DreamStation Auto BiPAP, IT ITX700S15 93/42 DreamStation Auto BiPAP, LA LAX700S15 93/42 DreamStation Auto BiPAP, Latin America LAX700H15 93/42 DreamStation Auto BiPAP, ND NDX700S15 93/42 DreamStation Auto BiPAP, Ukraine UAX700S15 93/42 DreamStation Auto BiPAP, US EUX700S15 93/42 DreamStation Auto CPAP Cell, BL BLX500S15C 93/42 DreamStation Auto CPAP Humidifier, Mediq BLX500H15MQ 93/42 DreamStation Auto CPAP w/Cell ES ESX500S15C 93/42 DreamStation Auto CPAP w/Humid w/H Tube, AU AUX500T15 93/42 DreamStation Auto CPAP w/Humid w/H Tube, INTL INX500T15 93/42 DreamStation Auto CPAP w/Humid w/H Tube, w/Cell, AU AUX500T15C 93/42 DreamStation Auto CPAP w/Humid, GB Rent RGBX500H15 93/42 DREAMSTATION AUTO CPAP W/HUMIDCell, LA LAX500H15C 93/42 DREAMSTATION AUTO CPAP W/HUMIDIFIER Cell ARX500H15C 93/42 DreamStation Auto CPAP w/Humidifier, w/Cell, Praxair, PT PTX500H15PRC 93/42 DreamStation Auto CPAP w/Humidifier, w/H Tube, LA LAX500T15 93/42 DreamStation Auto CPAP w/Humidifier, w/WiFi, IT ITX500H15W 93/42 DreamStation Auto CPAP w/Humidifier, w/WiFi, Praxair, PT PTX500H15PRW 93/42 DreamStation Auto CPAP w/Humidifier/Cell, BL BLX500H15C 93/42 DreamStation Auto CPAP w/Humidifier/Cell, ND NDX500H15C 93/42 DreamStation Auto CPAP w/ith Humidifier/Cell ES ESX500H15C 93/42 DreamStation Auto CPAP w/WiFi, FR FRX500S14W 93/42 DreamStation Auto CPAP with Humidifier, AR ARX500H15 93/42 DreamStation Auto CPAP with Humidifier, AU AUX500H15 93/42 DreamStation Auto CPAP with Humidifier, BL BLX500H15 93/42 DreamStation Auto CPAP with Humidifier, EE EEX500H15 93/42 DreamStation Auto CPAP with Humidifier, ES ESX500H15 93/42 DreamStation Auto CPAP with Humidifier, EU EUX500H15 93/42 DreamStation Auto CPAP with Humidifier, GB GBX500H15 93/42 DreamStation Auto CPAP with Humidifier, INTL INX500H15 93/42 DreamStation Auto CPAP with Humidifier, Latin America LAX500H15 93/42 DreamStation Auto CPAP with Humidifier, ND NDX500S15 93/42 DreamStation Auto CPAP with Humidifier, Praxair, PT PTX500H15PR 93/42 DreamStation Auto CPAP with Humidifier, TR TRX500H15 93/42 DreamStation Auto CPAP, AR ARX500S15 93/42 DreamStation Auto CPAP, AU AUX500S15 93/42 DreamStation Auto CPAP, BL BLX500S15 93/42 DreamStation Auto CPAP, DE DEX500S13 93/42 DreamStation Auto CPAP, EE EEX500S15 93/42 DreamStation Auto CPAP, ES ESX500S15 93/42 DreamStation Auto CPAP, EU EUX500S15 93/42 DreamStation Auto CPAP, FR FRX500S14 93/42 DreamStation Auto CPAP, GB GBX500S15 93/42 DreamStation Auto CPAP, GB Rental RGBX500S15 93/42 DreamStation Auto CPAP, INTL 93/42 DreamStation Auto CPAP, IT ITX500S15 93/42 DreamStation Auto CPAP, Latin America LAX500S15 93/42 DreamStation Auto CPAP, ND NDX500H15 93/42 DreamStation Auto CPAP, TR TRX500S15 93/42 DreamStation Auto CPAP, Ukraine UAX500S15 93/42 DreamStation Auto FR Recert UFRX500S14 93/42 DreamStation autoSV with Humidifier, no Bluetooth, LA LAX900H19 93/42 DreamStation AutoSV, Ukraine UAX900S15 93/42 DreamStation AVAPS 25 w/Heated Humidifier, No Bluetooth, EU EUX1125H19 93/42 DreamStation AVAPS 25 w/Hum,no Bluetooth, INTL INX1125H19 93/42 DreamStation AVAPS 25 w/Humid w/H Tube, no Bluetooth, INTL INX1125T19 93/42 DreamStation AVAPS 25, EU EUX1125S15 93/42 DreamStation AVAPS 25, IT ITX1125S21 93/42 DreamStation AVAPS 25, No Bluetooth, EU EUX1125S19 93/42 DreamStation AVAPS 25, no Bluetooth, Intl INX1125S19 93/42 DreamStation AVAPS 30 AAM ND NDX1130S15 93/42 DreamStation AVAPS 30 AAM w/Hum,no Bluetooth, INTL INX1130H19 93/42 DreamStation AVAPS 30 AAM, no Bluetooth, INTL INX1130S19 93/42 DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, INTL INX1131T19 93/42 DreamStation AVAPS 30 with Heated Humidifier, AAM ND NDX1130H15 93/42 DreamStation AVAPS 30 with Heated Humidifier, ND NDX1130H20 93/42 DreamStation AVAPS 30, ND NDX1130S20 93/42 DreamStation AVAPS30 AAM, VT VTX1130S24 93/42 DreamStation BiPAP Auto Rental RDEX700S13 93/42 DreamStation BiPAP autoSV , No Bluetooth, EU EUX900S19 93/42 DreamStation BiPAP autoSV w/ Humid, DE Rental RDEX900H13 93/42 DreamStation BiPAP autoSV w/ Humid, GB Rental RGBX900H15 93/42 DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU AUX900T15C 93/42 DreamStation BiPAP autoSV w/humid w/h tube, no bluetooth, LA LAX900T19 93/42 DreamStation BiPAP autoSV w/Humid, No Bluetooth, EU EUX900H19 93/42 DreamStation BiPAP autoSV w/Humid, no Bluetooth, INTL INX900H19 93/42 DreamStation BiPAP autoSV w/Humid, no Bluetooth, ZA ZAX900H19 93/42 DreamStation BiPAP autoSV w/Humidifier, AU AUX900T15 93/42 DreamStation BiPAP autoSV w/Humidifier, BL BLX900H15 93/42 DreamStation BiPAP autoSV w/Humidifier, ES ESX900H15 93/42 DreamStation BiPAP autoSV w/Humidifier, TR TRX900H15 93/42 DreamStation BiPAP AutoSV with Humidifier, FR FRX900H14 93/42 DreamStation BiPAP autoSV with Humidifier, ND NDX900H15 93/42 DreamStation BiPAP autoSV with WiFi, FR FRX900S14W 93/42 DreamStation BiPAP autoSV, AU AUX900S15 93/42 DreamStation BiPAP autoSV, BL BLX900S15 93/42 DreamStation BiPAP AutoSV, DE DEX900S13 93/42 DreamStation BiPAP autoSV, DE Rental RDEX900S13 93/42 DreamStation BiPAP AutoSV, EE EEX900S15 93/42 DreamStation BiPAP autoSV, ES ESX900S15 93/42 DreamStation BiPAP AutoSV, EU EUX900S15 93/42 DreamStation BiPAP AutoSV, FR FRX900S14 93/42 DreamStation BiPAP AutoSV, GB GBX900S15 93/42 DreamStation BiPAP autoSV, GB Rental RGBX900S15 93/42 DreamStation BiPAP AutoSV, IT ITX900S15 93/42 DreamStation BiPAP autoSV, ND NDX900S15 93/42 DreamStation BiPAP autoSV, no Bluetooth, INTL INX900S19 93/42 Dreamstation BiPAP autoSV, no Bluetooth, LA LAX900S19 93/42 DreamStation BiPAP autoSV, no Bluetooth, ZA ZAX900S19 93/42 DreamStation BiPAP autoSV, TR TRX900S15 93/42 DreamStation BiPAP autoSV, w/Hum w/HTube, no BT, INTL INX900T19 93/42 DreamStation BiPAP AVAPS 30 AAM no Bluetooth, EU EUX1130S19 93/42 DreamStation BiPAP AVAPS 30 AAM, ES ESX1130S15 93/42 DreamStation BiPAP AVAPS 30 AAM, EU EUX1130S15 93/42 DreamStation BiPAP AVAPS 30 AE No Bluetooth. INTL INX1131S19 93/42 DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU AUX1131T15 93/42 DreamStation BiPAP AVAPS 30 AE, AU AUX1131S15 93/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier AAM, FR FRX1130H14 93/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM DE DEX1130H13 93/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EE EEX1130H22 93/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EU EUX1130H15 93/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, EU EUX1125H15 93/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, GB GBX1130H20 93/42 DreamStation BiPAP AVAPS 30 w/HTD Humid, No BT, EU EUX1130H19 93/42 DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, INTL INX1130T19 93/42 DreamStation BiPAP AVAPS 30, AAM w/ Humidifier, ES ESX1130H15 93/42 DreamStation BiPAP AVAPS 30, GB GBX1130S20 93/42 DreamStation BiPAP AVAPS 30, IT ITX1130S21 93/42 DreamStation BiPAP AVAPS30 AAM BL BLX1130S15 93/42 DreamStation BiPAP AVAPS30 AAM no Bluetooth, UA UAX1130S19 93/42 DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA ZAX1130H19 93/42 DreamStation BiPAP AVAPS30 AAM w/Humid, NO Bluetooth, UA UAX1130H19 93/42 DreamStation BiPAP AVAPS30 AAM w/Humidifier, BL BLX1130H15 93/42 DreamStation BiPAP AVAPS30 AAM w/Humidifier, TR TRX1130H15 93/42 DreamStation BiPAP AVAPS30 AAM, EE EEX1130S22 93/42 DreamStation BiPAP AVAPS30 AAM, FR FRX1130S14 93/42 DreamStation BiPAP AVAPS30 AAM, Linde EOLUS LDX1130S23 93/42 DreamStation BiPAP AVAPS30 AAM, MedicAir, Respi Comfort MDX1130S25 93/42 DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA ZAX1130S19 93/42 DreamStation BiPAP AVAPS30 AAM, TR TRX1130S15 93/42 DreamStation BiPAP AVAPS30 AAM, w/ Humidifier,Linde EOLUS LDX1130H23 93/42 DreamStation BiPAP AVAPS30 AE AAM w/Humidifier, AU AUX1131H15 93/42 DreamStation BiPAP AVAPS30 AE w/Cell, AU AUX1131S15C 93/42 DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU AUX1131T15C 93/42 DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WiFi AU AUX1131T15W 93/42 DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, AU AUX1131H15C 93/42 DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AU AUX1131H15W 93/42 DreamStation BiPAP AVAPS30 AE w/WiFi, AU AUX1131S15W 93/42 DreamStation BiPAP AVAPS30 with Humidifier, SP SPX1130H21 93/42 DreamStation BiPAP AVAPS30, GB Rental RGBX1130S20 93/42 DreamStation BiPAP AVAPS30, SP SPX1130S21 93/42 DREAMSTATION BIPAP PRO W/HUMID Cell LA LAX600H15C 93/42 DreamStation BiPAP Pro w/Humid w/H Tube, Latin America LAX600T15 93/42 DreamStation BiPAP Pro w/Humidi w/H Tube, INTL INX600T15 93/42 DreamStation BiPAP Pro with Humidifier, AR ARX600H15 93/42 DreamStation BiPAP Pro with Humidifier, EU EUX600H15 93/42 DreamStation BiPAP Pro with Humidifier, INTL INX600H15 93/42 DreamStation BiPAP Pro with Humidifier, Latin America LAX600H15 93/42 DreamStation BiPAP Pro with Humidifier, TR TRX600H15 93/42 DreamStation BiPAP Pro, AR ARX600S15 93/42 DreamStation BiPAP Pro, BL BLX600S15 93/42 DreamStation BiPAP Pro, EU EUX600S15 93/42 DreamStation BiPAP Pro, INTL INX600S15 93/42 DreamStation BiPAP Pro, Latin America LAX600S15 93/42 DREAMSTATION BIPAP PRO,Cell Modem, AR ARX600S15C 93/42 DreamStation BiPAP S/T 25 w/ HTD Humid, No BT, EU EUX1025H19 93/42 DreamStation BiPAP S/T 25 w/Heated Humidifier, EU EUX1025H15 93/42 DreamStation BiPAP S/T 25, DE DEX1025S13 93/42 DreamStation BiPAP S/T 25, EU EUX1025S15 93/42 DreamStation BiPAP S/T 25, no Bluetooth, EU EUX1025S19 93/42 DreamStation BiPAP S/T 30 AAM , No Bluetooth, EU EUX1030S19 93/42 DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, ES ESX1030H15 93/42 DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, EU EUX1030H15 93/42 DreamStation BiPAP S/T 30 AAM, DE DEX1130S13 93/42 DreamStation BiPAP S/T 30 AAM, EU EUX1030S15 93/42 DreamStation BiPAP S/T 30 with Heated Humidifier, GB GBX1030H20 93/42 DreamStation BiPAP S/T 30, GB GBX1030S20 93/42 DreamStation BiPAP S/T ST30 AAM, ES ESX1030S15 93/42 DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL INX1025T19 93/42 DreamStation BiPAP S/T25, No Bluetooth, IN INX1025H19 93/42 DreamStation BiPAP S/T25, no Bluetooth, INTL INX1025S19 93/42 DreamStation BiPAP S/T30 AAM BL BLX1030S15 93/42 DreamStation BiPAP S/T30 AAM no Bluetooth, INTL INX1030S19 93/42 DreamStation BiPAP S/T30 AAM TR TRX1030S15 93/42 DreamStation BiPAP S/T30 AAM w/Hum w/HTube, no BT,INTL INX1030T19 93/42 DreamStation BiPAP S/T30 AAM w/Hum, no Bluetooth, ZA ZAX1030H19 93/42 DreamStation BiPAP S/T30 AAM w/Humidifier, BL BLX1030H15 93/42 DreamStation BiPAP S/T30 AAM w/Humidifier, DE DEX1030H13 93/42 DreamStation BiPAP S/T30 AAM w/Humidifier, TR TRX1030H15 93/42 DreamStation BiPAP S/T30 AAM, DE DEX1030S13 93/42 DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA ZAX1030S19 93/42 DreamStation BiPAP S/T30 w/ Humidifier, ES ESX1030H20 93/42 DreamStation BiPAP S/T30 w/Hum,no Bluetooth,AAM INTL INX1030H19 93/42 DreamStation BiPAP S/T30 with Humidifier, IT ITX1030H20 93/42 DreamStation BiPAP S/T30, EE EEX1030S22 93/42 DreamStation BiPAP S/T30, ES ESX1030S20 93/42 DreamStation BiPAP S/T30, IT ITX1030S20 93/42 DreamStation BiPAP ST30 AAM no Bluetooth, UA UAX1030S19 93/42 DreamStation BiPAP ST30 AAM w/Humid, no Bluetooth, UA UAX1030H19 93/42 DreamStation BiPAP Synchrony AVAPS AAM SAX1130S27 93/42 DreamStation BiPAP Synchrony AVAPS AAM, with Humidifier SAX1130H27 93/42 DreamStation CPAP Pro Cell, BL BLX400S15C 93/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, AR ARX401H15 93/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, ES ESX401H15 93/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, EU EUX401H15 93/42 DreamStation CPAP Pro w/ Auto-Trial, EU EUX401S15 93/42 DreamStation CPAP Pro w/Cell ES ESX401S15C 93/42 DREAMSTATION CPAP PRO W/HUMID Cell LA LAX400H15C 93/42 DreamStation CPAP Pro w/Humid w/H Tube, INTL INX400T15 93/42 DreamStation CPAP Pro w/Humid w/H Tube, LA LAX400T15 93/42 DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, AU AUX400T15C 93/42 DreamStation CPAP Pro w/Humid w/Heated Tube, AU AUX400T15 93/42 DreamStation CPAP Pro w/Humid, PW, 22mm PWX401H15 93/42 DREAMSTATION CPAP PRO W/HUMIDIFIER, Cell ARX401H15C 93/42 DreamStation CPAP Pro w/Humidifier, w/WiFi, IT ITX400H15W 93/42 DreamStation CPAP Pro w/Humidifier/Cell, BL BLX400H15C 93/42 DreamStation CPAP Pro with C Flex with Humidifier, GB GBX401H15 93/42 DreamStation CPAP Pro with C-Flex, AR ARX401S15 93/42 DreamStation CPAP Pro with C-Flex, ES ESX401S15 93/42 DreamStation CPAP Pro with C-Flex, GB GBX401S15 93/42 DreamStation CPAP Pro with Humidifier, AU AUX400H15 93/42 DreamStation CPAP Pro with Humidifier, BL BLX400H15 93/42 DreamStation CPAP Pro with Humidifier, EE EEX400H15 93/42 DreamStation CPAP Pro with Humidifier, ES ESX400H15 93/42 DreamStation CPAP Pro with Humidifier, EU EUX400H15 93/42 DreamStation CPAP Pro with Humidifier, GB GBX400H15 93/42 DreamStation CPAP Pro with Humidifier, INTL INX400H15 93/42 DreamStation CPAP Pro with Humidifier, Latin America LAX400H15 93/42 DreamStation CPAP Pro with Humidifier, TR TRX400H15 93/42 DreamStation CPAP Pro with Humidifier/Cell ES ESX401H15C 93/42 DreamStation CPAP Pro, AU AUX400S15 93/42 DreamStation CPAP Pro, BL BLX400S15 93/42 DreamStation CPAP Pro, DE DEX400S13 93/42 DreamStation CPAP Pro, EE EEX400S15 93/42 DreamStation CPAP Pro, ES ESX400S15 93/42 DreamStation CPAP Pro, EU EUX400S15 93/42 DreamStation CPAP Pro, FR FRX400S14 93/42 DreamStation CPAP Pro, GB GBX400S15 93/42 DreamStation CPAP Pro, INTL INX400S15 93/42 DreamStation CPAP Pro, IT ITX400S15 93/42 DreamStation CPAP Pro, Latin America LAX400S15 93/42 DreamStation CPAP Pro, PW, 22mm PWX401S15 93/42 DreamStation CPAP Pro, TR TRX400S15 93/42 DreamStation CPAP Pro, Ukraine UAX400S15 93/42 DreamStation CPAP w/ Humid/HT, LA LAX200T15 93/42 DreamStation CPAP w/AHI ES ESX201S15 93/42 DreamStation CPAP w/AHI, BL BLX201S15 93/42 DreamStation CPAP w/AHI/Cell ES ESX201S15C 93/42 DreamStation CPAP w/AHI/Cell, BL BLX201S15C 93/42 DREAMSTATION CPAP W/HUMID,LA,Cell Modem, LAX200H15C 93/42 DREAMSTATION CPAP W/HUMIDIFIER, Cell Mod ARX200H15C 93/42 DreamStation CPAP w/Humidifier, w/Heated Tube, INTL INX200T15 93/42 DreamStation CPAP with Humidifier, AR ARX200H15 93/42 DreamStation CPAP with Humidifier, BL BLX200H15 93/42 DreamStation CPAP with Humidifier, EU EUX200H15 93/42 DreamStation CPAP with Humidifier, INTL INX200H15 93/42 DreamStation CPAP with Humidifier, Latin America LAX200H15 93/42 DreamStation CPAP with Humidifier, TR TRX200H15 93/42 DreamStation CPAP, AR ARX200S15 93/42 DreamStation CPAP, BL BLX200S15 93/42 DreamStation CPAP, ES ESX200S15 93/42 DreamStation CPAP, EU EUX200S15 93/42 DreamStation CPAP, INTL INX200S15 93/42 DreamStation CPAP, IT ITX200S15 93/42 DreamStation CPAP, LA LAX200S15 93/42 DreamStation CPAP, TR TRX200S15 93/42 DreamStation Expert w/Humidifier, w/WiFi, FR FRX501H14W 93/42 DreamStation Expert, FR FRX501S14 93/42 DreamStation Flow Generator Cover 1128163 93/42 DreamStation REMstar Auto Rental RDEX500S13 93/42 DreamStation REMstar Pro Rental RDEX400S13 93/42 DreamStation S/T 30 w/Heated Humidifier, EE EEX1030H22 93/42 DreamStation S/T 30 w/HTD Humid, No BT, AAM, EU EUX1030H19 93/42 DreamStation ST 30 AAM, ND NDX1030S15 93/42 DreamStation ST 30 with Heated Humidifier, AAM, ND NDX1030H15 93/42 DreamStation ST 30 with Heated Humidifier, ND NDX1030H20 93/42 DreamStation ST 30, ND NDX1030S20 93/42 DreamStation Travel Kit, 65W P/S, AU AU1120135 93/42 DreamStation Travel Kit, 65W P/S, EU 93/42 DreamStation Travel Kit, 65W P/S, IN IN1120135 93/42 DreamStation, BiPAP AutoSV with Humidifier, DE DEX900H13 93/42 DreamStation, BiPAP AutoSV with Humidifier, EE EEX900H15 93/42 DreamStation, BiPAP AutoSV with Humidifier, EU EUX900H15 93/42 DreamStation, BiPAP AutoSV with Humidifier, GB GBX900H15 93/42 DreamStation, BiPAP AutoSV with Humidifier, IT ITX900H15 93/42 DreamStation, BiPAP S/T30, FR FRX1030S14 93/42 DREAMSTATIONAUTO BIPAP, AR+ Cell Modem, ARX700S15C 93/42 DS2 Adv Auto CPAP w/Humid cell/BT, BL BLX520H15C 93/42 DS2 Adv CPAP w/Humid cell/BT, BL BLX420H15C 93/42 DS2 Auto CPAP w/Humid cell/BT, DE DEX420H13C 93/42 DS2 CPAP w/Humid cell/BT, ES ESX410H15C 93/42 DS2 CPAP w/Humid cell/BT, IT ITX410H15C 93/42 DS2Adv Auto CPAP w/Humid BT only, EU EUX520H15 93/42 DS2Adv Auto CPAP w/Humid cell/BT, EU EUX520H15C 93/42 DS2Adv Auto CPAP w/Humid cell/BT, GB GBX520H15C 93/42 DS2Adv Auto CPAP w/Humid/HT cell/BT, ND NDX520T15C 93/42 DS2Adv CPAP w/Humid cell/BT, EE EEX420H15C 93/42 DS2Adv CPAP w/Humid cell/BT, IT ITX420H15C 93/42 Dual Limb Active Exhalation Valve 1132110 93/42 Dual Limb Active Exhalation Valve 1139436 93/42 External Flow Sensor Cable 1134592 93/42 External Flow Sensor w/Cable, Adult/Ped 1132106 93/42 External Flow Sensor w/Cable,Ped/Infant 1132107 93/42 External Flow Sensor, Adult/Ped 1134711 93/42 External Flow Sensor, Ped/Infant 1134712 93/42 FEP Circuit S/A w/Filter – INTL Single Use Filtered Exhalation Port Circuit 93/42 FEP Circuit S/A W/O Filters 1069211 93/42 Filtered Exhalation Port (FEP) FPH 150PK 1140613 93/42 Filtered Exhalation Port (FEP) S/A, 150PK 1134664 93/42 Flex Trach Adapt 15cm,22M/15F-15 10pk 1073863 93/42 Flex Trach Adapt 15cm,22M/15F-22F10pk 1073902 93/42 Flex Trach Adapter 15cm, 22M/15F-15 20 pk 1073903 93/42 Garbin Evo, Linde 93/42 HOSE,22mm-18IN,NON-AUTOCLAV 93/42 Kit, Active Exhalation Valve UPB 1075459 93/42 LifeVentEVO2 93/42 MPV Replacement Straw Kit 1118840 93/42 MPV Support System Kit 1102862 93/42 Oxygen O2 Enrichment Attachment 02 Enrichment Attachmnt Sngl 93/42 Pediatric Invasive Passive Disposable Non-Heated Circuit 1069445 93/42 Philips NightBalance, Refurbishment Kit, DK 93/42 Pressure Valve, 5 Pack 302423 93/42 REMstar Pro C-Flex+, System One 60 Series, DE REMstar System (60 Series) 93/42 Rental, DreamStation ST30, GB RGBX1030S20 93/42 SimplyGo External Battery Module 2 refs SimplyGo Mini Extended Battery Kit 2 refs Single Use Filtered Exhalation Port Circuit CKT FILTER DEP W/FEP 10PK INTL 93/42 Trilogy 100 Ventilator,Germany-BT-RENT Trilogy 100, Trilogy EC 93/42 Trilogy 200 Ventilator, Intl-Recert 93/42 Trilogy Active Flow Exhalation Circuit, Pediatric 1068838 93/42 Trilogy Active with PAP Exhalation Circuit, Adult 1052064 93/42 Trilogy Active with PAP Exhalation Circuit, Pediatric 1052065 93/42 Trilogy EV300, Benelux 93/42 Trilogy EV300, Eastern Europe 93/42 Trilogy EV300, EU 93/42 Trilogy EV300, EU (Non-BT) 93/42 Trilogy EV300, France 93/42 Trilogy EV300, Germany 93/42 Trilogy EV300, Great Britain 93/42 Trilogy EV300, INT w/ OBM 93/42 Trilogy EV300, INTL 93/42 Trilogy EV300, Italy 93/42 Trilogy EV300, Nordics 93/42 Trilogy EV300, Spain 93/42 Trilogy EV300, Turkey 93/42 Trilogy Evo O2, Benelux 93/42 Trilogy Evo O2, Eastern Europe 93/42 Trilogy Evo O2, France 93/42 Trilogy Evo O2, Germany 93/42 Trilogy Evo O2, Great Britain 93/42 Trilogy Evo O2, Iberia 93/42 Trilogy Evo O2, Italy 93/42 Trilogy Evo O2, Nordics 93/42 Trilogy Evo, Benelux 93/42 Trilogy Evo, Eastern Europe 93/42 Trilogy Evo, EU 93/42 Trilogy Evo, EU (Non-BT) 93/42 Trilogy Evo, France 93/42 Trilogy Evo, Germany 93/42 Trilogy Evo, Great Britain 93/42 Trilogy Evo, Iberia 93/42 Trilogy Evo, INT 93/42 Trilogy Evo, International 93/42 Trilogy Evo, International (Non-BT) 93/42 Trilogy Evo, Italy 93/42 Trilogy Evo, Latin America LA2110X15B 93/42 Trilogy Evo, Nordics 93/42 Trilogy Evo, O2, EU 93/42 Trilogy Evo, O2, EU (Non-BT) 93/42 Trilogy Evo, O2, INT 93/42 Trilogy Evo, O2, International 93/42 Trilogy Evo, O2, International (Non-BT) 93/42 Trilogy Evo, O2, Latin America LA2100X15B 93/42 Trilogy Evo, O2, Turkey TR2100X15B 93/42 Trilogy Evo, Turkey TR2110X15B 93/42 Trilogy Passive Exhalation Circuit, Adult 1052066 93/42 Trilogy Passive Exhalation Circuit, Pediatric 1052127 93/42 Trilogy, Mouthpiece Ventilation Disposable Circuit 1102866 93/42 Trilogy, Mouthpiece Ventilation Disposable Circuit 1102869 93/42 Trilovy EV300, O2 Australia AU2110X15B 93/42 Whisper Swivel II Packaged 93/42 "Alice PDx ECG Yoke Cable, Intl " 93/42 (no longer marketed) (10) BiPAP Disposable Humidifier Tubing 36 IN (91cm) 93/42 (no longer marketed) (10) Disposable Proximal Pressure Line Assembly 93/42 (no longer marketed) Actiware Clinical Trial Software, English - 6 93/42 (no longer marketed) Actiware Software CD - 6 93/42 (no longer marketed) Actiware Software Pkg., Addl License BOM 93/42 (no longer marketed) Actiware Software Web Download - 6 93/42 (no longer marketed) Actiwatch Spectrum Device Actiwatch 2 and Actiwatch Spectrum 93/42 (no longer marketed) Actiwatch Spectrum Plus-Recertified 93/42 (no longer marketed) Actiwatch Spectrum Plus-Rental 93/42 (no longer marketed) Actiwatch Spectrum PRO 93/42 (no longer marketed) Actiwatch Spectrum PRO-Recertified 93/42 (no longer marketed) Actiwatch Spectrum PRO-Rental 93/42 (no longer marketed) Alice 5 International Base Unit Only 1017230 93/42 (no longer marketed) Alice 5 International Headbox 1017231 93/42 (no longer marketed) Alice LE System INTL Alice 5 and Alice LE Polysomnography Systems 93/42 (no longer marketed) Alice Night One, Wireless, Ukraine 93/42 (no longer marketed) Alice NightOne Non-Wireless, Warranty, INTL 93/42 (no longer marketed) Alice NightOne System Intl, Wireless, Rental 93/42 (no longer marketed) Alice NightOne Wireless Device, INTL 93/42 (no longer marketed) Alice NightOne Wireless, Warranty ,INTL 93/42 (no longer marketed) Alice NightOne, Non-Wireless Device, INTL 93/42 (no longer marketed) Alice NightOne, Wireless, Masimo, INTL 93/42 (no longer marketed) Alice PDx Core System without Sensors, INTL 93/42 (no longer marketed) ALICE PDx Diagnostic System International, Rental 93/42 (no longer marketed) Alice PDx ECG Yoke, INTL 93/42 (no longer marketed) Alice PDx ExG Yoke, INTL 93/42 (no longer marketed) ALICE PDX Portable Sleep Diagnostic System International 93/42 (no longer marketed) Alice PDx Sleep Diagnostic System, INTL 93/42 (no longer marketed) Alice PDx Unit Only, Warranty Exchange, INTL 93/42 (no longer marketed) AW CT Sanifit SNFCT2020-07 Scorer 93/42 (no longer marketed) AW CT Sanifit SNFCT2020-07 Site 93/42 (no longer marketed) AW CT Bayer 20887 Scorer 93/42 (no longer marketed) AW CT Bayer 20887 Site 93/42 (no longer marketed) AW CT Insmed INS 415 Pkg Scorer 93/42 (no longer marketed) AW CT Insmed INS 415 Pkg Site 93/42 (no longer marketed) AW CT Insmed INS 416 Pkg Scorer 93/42 (no longer marketed) AW CT Insmed INS 416 Pkg Site 93/42 (no longer marketed) AW CT Janssen 42756493BLC3001 Pkg Scorer 93/42 (no longer marketed) AW CT Janssen 42847922MDD1005 Site 93/42 (no longer marketed) AW CT Janssen 42847922MDD3001 Scorer 93/42 (no longer marketed) AW CT Janssen 42847922MDD3001 Site 93/42 (no longer marketed) AW CT Janssen CNTO1275CRD3007 Pkg Scorer 93/42 (no longer marketed) AW CT Janssen NOPRODBIP0001 Pkg Scorer 93/42 (no longer marketed) AW CT Kiniksa KPL-716-C001 Pkg Scorer 93/42 (no longer marketed) AW CT Kiniksa KPL-OBS001 Pkg Scorer 93/42 (no longer marketed) AW CT Koneksa Pkg LPS16677 Site 93/42 (no longer marketed) AW CT MT-8554-E06 Pkg Scorer 93/42 (no longer marketed) AW CT Novartis CAIN457FUS06 Pkg Scorer 93/42 (no longer marketed) AW CT Ovid OV101-17-001 Pkg Scorer 93/42 (no longer marketed) AW CT Ovid OV101-17-002 Pkg Scorer 93/42 (no longer marketed) AW CT Regeneron R3500-AD-1798 Pkg Scorer 93/42 (no longer marketed) AW CT Roche BP29937 Pkg Scorer 93/42 (no longer marketed) AW CT TAK-994-1503 Scorer 93/42 (no longer marketed) AW CT TAK-994-1503 Site 93/42 (no longer marketed) AW CT Takeda TAK-925-2001 Pkg Scorer 93/42 (no longer marketed) AW CT Takeda TAK-925-2001 Pkg Site 93/42 (no longer marketed) AW CT Takeda TAK-925-2002 Pkg Scorer 93/42 (no longer marketed) AW CT Takeda TAK-994-1501 Pkg Site 93/42 (no longer marketed) AW CT Ultragenyx UX701-CL001 Pkg Site 93/42 (no longer marketed) AW CT Vanda VP-VEC-162-3502 Pkg Scorer 93/42 (no longer marketed) AW CT Vanda VP-VEC-162-3502 Pkg Site 93/42 (no longer marketed) BiPAP A30 Ventilator France 93/42 (no longer marketed) BiPAP A30 Ventilator Private Label, INTL 93/42 (no longer marketed) BiPAP A30 Ventilator, INTL 93/42 (no longer marketed) BiPAP A30, International-Rental 2 refs 93/42 (no longer marketed) BiPAP A30, Linde Eolus 30 93/42 (no longer marketed) BiPAP A30, Medicair Respicomfort 93/42 (no longer marketed) BiPAP A30, Silver Series- RENTAL 93/42 (no longer marketed) BiPAP A30, Vitalaire Vitalvent 30 93/42 (no longer marketed) BiPAP A30-S Silver Series 93/42 (no longer marketed) BiPAP A30-S Silver Series - RENTAL 93/42 (no longer marketed) BiPAP A40 Silver Series BiPAP A40 Ventilator 93/42 (no longer marketed) BiPAP A40 Ventilator Private Label, INTL 93/42 (no longer marketed) BiPAP A40 Ventilator, FR 93/42 (no longer marketed) BiPAP A40 Ventilator, INTL 93/42 (no longer marketed) BiPAP A40 Ventilator, IT 93/42 (no longer marketed) BiPAP A40, International-Rental 93/42 (no longer marketed) BiPAP A40, Silver Series - RENTAL 93/42 (no longer marketed) BiPAP Auto BiFlex System One 60 Series INT REMstar System (60 Series) 93/42 (no longer marketed) BiPAP Auto BiFlex w/Humidifier System One 60 Series,GB REMstar System (60 Series) 93/42 (no longer marketed) BiPAP Auto BiFlex, System One 60 Series, GB REMstar System (60 Series) 93/42 (no longer marketed) BiPAP Auto BiFlex, System One, 60 Series, IT BiPAP Auto Bi-Flex 93/42 (no longer marketed) BiPAP Auto BiFlex, w/HT Humid System One 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) BiPAP Auto BiFlex, w/Humid System One 60 Series INT REMstar System (60 Series) 93/42 (no longer marketed) BiPAP autoSV ADV 60 Series, 30cm DE BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE 60 Series, INTL BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, INT BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV w/ HT Humid, 60 Series, 30cm INTL BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV, w/Humid 60 Series, 30cm, INTL BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP autoSV ADV,60 Srs, 30cm, DE Rental BiPAP autoSV Advanced System One 93/42 (no longer marketed) BiPAP Pro BiFlex System One 60 Series INT REMstar System (60 Series) 93/42 (no longer marketed) BiPAP Pro BiFlex, w/Humid System One 60 Series INT REMstar System (60 Series) 93/42 (no longer marketed) Cable, ExG Yoke, Alice PDx, Intl. Rental 93/42 (no longer marketed) CT Sanofi LPS15497 Software Pkg Scorer-6 93/42 (no longer marketed) CT Sanofi LPS15497 Software Pkg Site 93/42 (no longer marketed) CT XyloCor XC001-1001 SW Pkg Scorer 93/42 (no longer marketed) Disposable Invasive Circuits 93/42 (no longer marketed) Disposable Proximal Pressure Line, 84 in (213.36 cm) 93/42 (no longer marketed) Disposable Tubing 18 IN (46 cm)) QTY:10 BiPAP Disposable Circuits and Accessories 93/42 (no longer marketed) Disposable Tubing 6 IN (15.2) QTY:10 BiPAP Disposable Circuits and Accessories 93/42 (no longer marketed) Dorma 100 IT 93/42 (no longer marketed) Dorma 100 with Humidifier, INTL 93/42 (no longer marketed) Dorma 100, INTL 93/42 (no longer marketed) Dorma 100, Oxigen Salud 93/42 (no longer marketed) Dorma 200 with Humidifier, FR 93/42 (no longer marketed) Dorma 200 with SD Card, IT, con scheda SD, IT 93/42 (no longer marketed) Dorma 200, FR 93/42 (no longer marketed) Dorma 200, LD 93/42 (no longer marketed) Dorma 200, with Humidifier, LD 93/42 (no longer marketed) Dorma 400 w/Humid, DE 93/42 (no longer marketed) Dorma 400, DE- RENTAL 93/42 (no longer marketed) Dorma 500 Auto, IN 93/42 (no longer marketed) Dorma 500 Auto, INTL 93/42 (no longer marketed) Dorma 500 Auto, TR 93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, IN 93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, INTL 93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, TR 93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/BT only, EU 93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/BT only, IT 93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/Cell/BT, ND 93/42 (no longer marketed) DreamStation 2 Auto CPAP Humidifier/Cell/Bluetooth, EU DreamStation 2 CPAP/Auto CPAP 93/42 (no longer marketed) DreamStation 2 CPAP Humid/BT only, EU 93/42 (no longer marketed) DreamStation 2 CPAP Humid/BT only, IT 93/42 (no longer marketed) Garbin Plus Ventilator, Bluetooth, INTL Trilogy 200 93/42 (no longer marketed) Garbin Plus Ventilator, International 93/42 (no longer marketed) Garbin Ventilator — Bluetooth 93/42 (no longer marketed) Garbin Ventilator, Bluetooth, DE Trilogy 100, Trilogy EC 93/42 (no longer marketed) Garbin Ventilator, DE Trilogy 100, Trilogy EC 93/42 (no longer marketed) Garbin Ventilator, International Garbin Plus 93/42 (no longer marketed) Humidifier Tubing, 36 inch (91 cm) BiPAP Disposable Circuits and Accessories; Trilogy 93/42 (no longer marketed) InnoSpire Go EU1/ROW 93/42 (no longer marketed) InnoSpire Go EU2/ROW 93/42 (no longer marketed) InnoSpire Go LiteTouch Large Mask 93/42 (no longer marketed) InnoSpire Go LiteTouch Medium Mask 93/42 (no longer marketed) InnoSpire Go LiteTouch Small Mask 93/42 (no longer marketed) InnoSpire Go Mask Adapter 93/42 (no longer marketed) InnoSpire Go UK/INT 93/42 (no longer marketed) LifeVent200 Ventilator, Sapio, Bluetooth Trilogy 200 93/42 (no longer marketed) NightBalance 93/42 (no longer marketed) Novartis Software PkgScorer 93/42 (no longer marketed) Philips Basic Kit, PerformaTrak SE, INTL PerformaTrak SE Disposable Full Face Mask 93/42 (no longer marketed) Philips NightBalance DK 93/42 (no longer marketed) Philips NightBalance Mobile App, Android 93/42 (no longer marketed) Philips NightBalance Mobile App, iOS 93/42 (no longer marketed) Philips NightBalance NL 93/42 (no longer marketed) Philips NightBalance UK 93/42 (no longer marketed) Philips NightBalance, DE 93/42 (no longer marketed) Philips NightBalance, FR 93/42 (no longer marketed) Philips NightBalance, IB 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, Canada 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, DE 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, FR 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, NL 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, UK 93/42 (no longer marketed) Philips NightBalance,Refurbishment Kit,IB 93/42 (no longer marketed) Portable electric ventilator BiPAP A30 93/42 (no longer marketed) Recert Trilogy 100 Ventilator,INTl - BT Trilogy 100, Trilogy EC 93/42 (no longer marketed) Recert, Alice NightOne Intl 93/42 (no longer marketed) Recert, Alice NightOne Intl Wireless 93/42 (no longer marketed) Recert-Trilogy 100 Vent,Germany -BT Trilogy 100, Trilogy EC 93/42 (no longer marketed) REMstar Auto A-Flex System One 60 Series, Italy REMstar System (60 Series) 93/42 (no longer marketed) REMstar Auto A-Flex, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar Auto A-Flex, System One 60 Series, GB REMstar System (60 Series) 93/42 (no longer marketed) REMstar Auto A-Flex, System One 60 Series, Germany REMstar System (60 Series) 93/42 (no longer marketed) REMstar Auto A-Flex, w/H Tube Humid, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar Auto A-Flex, w/Humid, System One 60 Srs, GB REMstar System (60 Series) 93/42 (no longer marketed) REMstar Auto A-Flex, with Humidifier, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar Plus C-Flex, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar Plus C-Flex, w/H Tube Humid, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar Pro C-Flex+ w/SD Card, INT Rental REMstar Pro C-Flex+ CPAP System 93/42 (no longer marketed) REMstar Pro C-Flex+, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar Pro C-Flex+, System One 60 Series, GB REMstar System (60 Series) 93/42 (no longer marketed) REMstar Pro C-Flex+, System One 60 Series, Italy REMstar System (60 Series) 93/42 (no longer marketed) REMstar Pro C-Flex+, w/HT Humid System One 60 Series INT 93/42 (no longer marketed) REMstar Pro C-Flex+, w/Humid, System One 60 Srs,GB REMstar System (60 Series) 93/42 (no longer marketed) REMstar Pro C-Flex+, with Humidifier, 60 Series, INTL REMstar System (60 Series) 93/42 (no longer marketed) REMstar SE with Heated Tube, with SD Slot, INTL 93/42 (no longer marketed) REMstar SE with HUMIDIFIER, with SD Slot, INTL 93/42 (no longer marketed) System One, Heated Tube System One Heated Humidifier SYS1HT15 93/42 (no longer marketed) Trilogy 100 Ventilator, Germany Trilogy100 Ventilator Germany 93/42 (no longer marketed) Trilogy 100 Ventilator, INTL — Bluetooth 93/42 (no longer marketed) Trilogy 100 Ventilator, INTL — Bluetooth Trilogy 100, Garbin 93/42 (no longer marketed) Trilogy 100 Ventilator, INTL-BT-RENT Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy 100 Ventilator, Italy - BT 93/42 (no longer marketed) Trilogy 200 93/42 (no longer marketed) Trilogy 200 Ventilator Germany Bluetooth 93/42 (no longer marketed) Trilogy 200 Ventilator, AERIS 200-BT 93/42 (no longer marketed) Trilogy 200 Ventilator, Germany 93/42 (no longer marketed) Trilogy 200 Ventilator, Germany-Recert 93/42 (no longer marketed) Trilogy 200 Ventilator, Germany-Rental 93/42 (no longer marketed) Trilogy 200 Ventilator, International 93/42 (no longer marketed) Trilogy 200 Ventilator, INTL-Bluetooth 93/42 (no longer marketed) Trilogy 200 Ventilator, Intl-Rental 93/42 (no longer marketed) Trilogy 200 Ventilator, Italy- BT 93/42 (no longer marketed) Trilogy 202 Ventilator Germany Trilogy 202/O2 93/42 (no longer marketed) Trilogy 202 Ventilator International Trilogy 202/O2 93/42 (no longer marketed) Trilogy 202 Ventilator,Intl-RENTAL Trilogy 202/O2 93/42 (no longer marketed) Trilogy Evo, Medic Air 93/42 (no longer marketed) Trilogy100 Ventilator, Bluetooth, Germany Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, Bluetooth, Italy Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, Germany Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, Germany-Recert Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, Germany-Rental Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, International Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, Intl-Recert Trilogy 100, Trilogy EC 93/42 (no longer marketed) Trilogy100 Ventilator, Intl-Rental Trilogy 100, Trilogy EC 93/42 (no longer marketed) ULTRAFILL,230V,EU 93/42 (no longer marketed)
I, IIa, IIb
MDR, 93/42
eudamed@philips.com
EUDAMED record
Report an error
Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
Türkiye
358 others
I, IIa, IIb
93/42
EUDAMED record
Report an error
S.M.I. Medical
Italy
326 others
IIa, IIb, III
93/42
info@smimedical.it
EUDAMED record
Report an error
Schlumbohm Medizin-Labor-Technologie-Hamburg
Germany
323 others
IIb, III
93/42
Website
EUDAMED record
Report an error
Cambridge Interventional FDA
EU representative : MDSS GmbH (Germany)
United States
306 others
IIa, IIb
93/42
Website
info@cambint.com
EUDAMED record
Report an error
Blazejewski
Germany
256 others Art. 019.30.0690a 93/42 Art. 019.30.1020a 93/42 Art. 019.30.1100a 93/42 Art. 020.30.0690a 93/42 Art. 024.00.1100a 93/42 Art. 024.30.0980a 93/42 Art. 024.30.1050a 93/42 Art. 024.30.1100a 93/42 Art. 027.00.1100a 93/42 Art. 027.00.1750a 93/42 Art. 027.00.1875 93/42 Art. 027.00.1875a 93/42 Art. 027.30.1100 93/42 Art. 027.30.1100a 93/42 Art. 027.30.1750a 93/42 Art. 027.30.1875a 93/42 Art. 030.00.1300a 93/42 Art. 030.30.1300a 93/42 Art. 040.00.1750a 3 refs 93/42 Art. 040.30.1700a 93/42 Art. 040.30.1755a 3 refs 93/42 Art. 040.45.1755a 2 refs 93/42 Art. 040.70.1760a 2 refs 93/42 Art. 050.00.1750a 93/42 Art. 050.30.1755a 93/42 BA-OP-45° Mul .073.15.0680 Ø2/Ø5 93/42 BA-OP-45° Mul .073.15.1500a Ø2/Ø5 93/42 BA-OP-45°-Mul. 058.45.1200a Ø2/Ø3,4 93/42 BA-OP-45°-Mul. 073.30.1710a Ø2,0 / Ø5,0 93/42 BA-OP-45°-Mul. 100.15.1250 Ø3/Ø6,5 93/42 BA-OP-45°-Mul.063.15.1710 Ø2/Ø4 93/42 BA-OP-45°-Mul.063.30.1710 Ø2/Ø4 93/42 BA-OP-45°-Mul.063.30.2080 Ø2/Ø4 93/42 BA-OP-45°. 053.30.0950a Ø2/Ø3 2 refs 93/42 BA-OP-45°. 058.45.1200a Ø2/Ø3,4 93/42 BA-OP-45°. 063.00.1810a Ø2/Ø4 93/42 BA-OP-45°. 063.30.1810a Ø2/Ø4 2 refs 93/42 BA-OP-45°. 063.30.2080a Ø2/Ø4 2 refs 93/42 BA-OP-45°. 069.30.1810a Ø2/Ø4,6 2 refs 93/42 BA-OP-45°. 084.15.1250a Ø2/Ø6 93/42 BA-OP-45°.036.00.1250 Ø3.6/Ø1.0/Ø2.4 93/42 BA-OP-45°.053.30.1300 Ø2/Ø3 93/42 BA-OP-45°.059.30.1810a Ø2/Ø3.7 93/42 BA-OP-45°.063.00.2080a Ø2/Ø4 93/42 BA-OP-45°.063.15.1710 Ø2/Ø4 93/42 BA-OP-45°.063.30.1250 Ø2/Ø4 93/42 BA-OP-45°.063.30.1300 Ø2/Ø4 93/42 BA-OP-45°.063.30.1300a Ø2/Ø4 93/42 BA-OP-45°.063.30.1710 Ø2/Ø4 93/42 BA-OP-45°.063.30.1710a Ø3/Ø3 93/42 BA-OP-45°.063.30.1810 Ø2/Ø4 2 refs 93/42 BA-OP-45°.063.30.2075a Ø3/Ø3 93/42 BA-OP-45°.063.30.2080 Ø2/Ø4 93/42 BA-OP-45°.063.30.2150a Ø3/Ø3 93/42 BA-OP-45°.069.15.1810 Ø2/Ø4,6 93/42 BA-OP-45°.069.30.1300 Ø2/Ø4,6 93/42 BA-OP-45°.069.30.1600 Ø2/Ø4,6 93/42 BA-OP-45°.070.30.1300a Ø2/Ø4,6 93/42 BA-OP-45°.070.30.1810a Ø2/Ø4,6 93/42 BA-OP-45°.073.15.0680 Ø2/Ø5 93/42 BA-OP-45°.073.15.1500a Ø2/Ø5 93/42 BA-OP-45°.073.30.1710a Ø2,0 / Ø5,0 93/42 BA-OP-45°.100.15.0740 Ø2/Ø7 93/42 BA-OP-45°.100.15.1000 Ø2/Ø7,4 93/42 BA-OP-45°.100.15.1250 Ø2/Ø7,4 93/42 BA-OP-45°.100.15.1250 Ø3/Ø6,5 2 refs 93/42 BA-OP-45°.100.15.1390 Ø2/Ø7,4 93/42 BA-OP-45°.100.15.1810 Ø2/Ø7,4 93/42 BA-OP-Mul.063.30.1250 Ø2/Ø4 93/42 Bro. 027.00.3020a 93/42 Bro. 027.30.3020a 93/42 Bro. 029.00.3020a 93/42 Bro. 029.30.3020a 93/42 Bro. 040.00.4900a 93/42 Bro. 040.30.4900a 93/42 Bro. 040.70.4900a 93/42 Bro. 050.00.4900a 93/42 Bro. 050.00.5440a 93/42 Bro. 050.30.4900a 93/42 Bro. 055.00.4900a 93/42 Bro. 055.00.5440a 2 refs 93/42 Bro. 055.30.4900a 93/42 Bro. 055.30.5440a 93/42 Bro. 055.70.5440a 93/42 CN Nep 90.069.15.2200 93/42 CN Nep.043.00.2200a 93/42 CN Nep.043.15.2200a 93/42 CN Nep.043.30.2200a 93/42 CN Nep.051.00.2200a 93/42 CN Nep.051.15.2200a 93/42 CN Nep.051.30.2200a 93/42 CN Nep.058.00.2200a 93/42 CN Nep.058.15.2200a 93/42 CN Nep.058.30.2200a 93/42 CN Nep.069.00.2200 93/42 CN Nep.069.15.2200 93/42 CN Nep.069.30.2200a 93/42 HWS Cervikal 040.09.1000 Mul. 93/42 Hys. 019.30.1875a 40k 93/42 Hys. 020.00.1875a 40k 93/42 Hys. 020.00.2600a 40k 93/42 Hys. 020.00.3020a 40k 93/42 Hys. 020.30.1875a 40k 93/42 Hys. 020.30.2600a 40k 93/42 Hys. 020.30.3020a 40k 93/42 Hys. 027.00.3020a 93/42 Hys. 027.00.3020a 40k 93/42 Hys. 027.15.3020a 93/42 Hys. 027.30.3020a 93/42 Hys. 027.30.3020a 40k 93/42 Hys. 029.00.3020a 93/42 Hys. 029.00.3020a 40k 93/42 Hys. 029.15.3020a 93/42 Hys. 029.30.3020a 93/42 Hys. 029.30.3020a 40k 93/42 Hys. 030.30.3020a 93/42 Hys. 040.00.3020a 93/42 Hys. 040.15.3020a 93/42 Hys. 040.30.3020a 93/42 Hys. 040.70.3020a 93/42 Hys. 050.00.2080 93/42 Hys. 050.70.3020a 93/42 Lap. 029.00.3020a 93/42 Lap. 029.30.3020a 93/42 Lap. 040.30.2300a 93/42 Lap. 050.00.3020a 2 refs 93/42 Lap. 050.30.2300a 93/42 Lap. 050.30.3020a 2 refs 93/42 Lap. 100.00.3160a 2 refs 93/42 Lap. 100.00.3446a 93/42 Lap. 100.00.3490a 93/42 Lap. 100.00.4000a 93/42 Lap. 100.00.4310a 93/42 Lap. 100.30.3172a 2 refs 93/42 Lap. 100.30.3458a 93/42 Lap. 100.30.3502a 93/42 Lap. 100.30.4322a 93/42 Lar. 040.70.1680a 93/42 Lar. 050.070.1760a mit gedrehtem Lichtleiter 93/42 Lar. 050.70.1680a 93/42 Lar. 050.70.1760a ohne Handgriff 93/42 Lar. 060.70.1660a 93/42 Lar. 080.70.1660 93/42 Lar. 080.70.1660a 2 refs 93/42 Lar. 100.70.1730a 93/42 Lar. 110.90.1730a 93/42 Lar. Paedr. Intubation 4 refs 93/42 Lup-Lar. 100.70.1475 93/42 Lup-Lar. 110.90.1450 93/42 MCC. 027.00.2200a 93/42 MCC. 030.00.2200a 93/42 MCC. 040.00.2200a 2 refs 93/42 MCN. 027.00.2200a 93/42 MCN. 030.00.2200a 93/42 MCN. 040.00.2200a 2 refs 93/42 MCN. 040.06.2200a 93/42 MCN. 040.X9.2200a 93/42 Naso. 019.00.0690a 93/42 Naso. 019.00.1020a 93/42 Naso. 019.30.0690a 93/42 Naso. 019.30.1020a 93/42 Naso. 020.30.0690a 93/42 Naso. 027.00.1100a 93/42 Naso. 027.00.1750a 93/42 Naso. 027.00.1875a 93/42 Naso. 027.30.1100a 93/42 Naso. 027.30.1750a 93/42 Naso. 027.30.1875a 93/42 Naso. 040.00.1750a 93/42 Naso. 040.00.2000a 93/42 Naso. 040.30.1755a 93/42 Naso. 040.30.2000a 93/42 Naso. 040.45.1755a 93/42 Naso. 040.70.1760a 93/42 Naso. 050.00.0880 93/42 Naso. 050.00.1750a 93/42 Naso. 050.30.1755a 93/42 Nep. 45.074.00.2000a 3 refs 93/42 Nep. 45.074.00.2500a 3 refs 93/42 Nep. 45.074.15.2000a 93/42 Nep. 45.074.15.2500a 93/42 Nep. 90.074.00.2000a 3 refs 93/42 Nep. 90.074.00.2500a 3 refs 93/42 Nep. 90.074.15.2000a 2 refs 93/42 Nep. 90.074.15.2500a 2 refs 93/42 Nep.45.074.15.2630a 93/42 Nep.90.074.15.2630a 93/42 OP-Lap. 45.100.00.2300a 93/42 OP-Lap. 45.100.00.2663a 93/42 OP-Lap. 90.100.00.2663a 93/42 Oto. 027.00.0260 93/42 Oto. 027.00.0410 2 refs 93/42 Oto. 027.00.0410a 93/42 Oto. 027.30.0410a 93/42 Oto. 040.00.0295 93/42 Oto. 040.00.0500a 2 refs 93/42 Oto. 040.30.0500a 2 refs 93/42 Rhizo Mul. 058.30.1250 Ø2/Ø3,4 93/42 Rhizo. Okular 058.30.1250a Ø2/Ø3,4 93/42 Tho. 100.00.2300a 93/42 Tho. 100.30.1812a 93/42 Tho. 100.30.2300a 93/42 Tho. 100.30.2312a 93/42 Tho.100.00.1800a 93/42 Uro. 018.00.2820 40k 93/42 Uro. 019.00.1875a 40k 93/42 Uro. 019.30.1875a 40k 93/42 Uro. 020.00.1875a 40k 93/42 Uro. 020.00.2600a 40k 93/42 Uro. 020.00.3020a 40k 93/42 Uro. 020.00.3120a 40k 2 refs 93/42 Uro. 020.09.2600a 40k 93/42 Uro. 020.09.3120a 40k 2 refs 93/42 Uro. 027.00.1875a 93/42 Uro. 027.00.3020 93/42 Uro. 027.00.3020a 93/42 Uro. 027.00.3020a 40k 93/42 Uro. 027.15.3020a 93/42 Uro. 027.30.1875a 93/42 Uro. 027.30.2460a 2 refs 93/42 Uro. 027.30.3020 93/42 Uro. 027.30.3020a 93/42 Uro. 029.00.3020 93/42 Uro. 029.00.3020a 93/42 Uro. 029.00.3020a 40k 93/42 Uro. 029.00.3030a 93/42 Uro. 029.15.3020a 93/42 Uro. 029.30.3020a 2 refs 93/42 Uro. 029.30.3030a 93/42 Uro. 030.00.3020a 93/42 Uro. 030.30.3020a 93/42 Uro. 040.00.3020a 3 refs 93/42 Uro. 040.15.2800a 93/42 Uro. 040.15.3020a 2 refs 93/42 Uro. 040.30.2820a 93/42 Uro. 040.30.3000a 93/42 Uro. 040.30.3020a 3 refs 93/42 Uro. 040.70.3020a 3 refs 93/42 Uro. 050.70.3020a 93/42 Uro.030.30.2820a 93/42 URS. 027.00.1500a 2 refs 93/42 URS. 027.00.3100a 2 refs 93/42 URS. 027.00.4250a 3 refs 93/42 URS. 030.00.1500a 2 refs 93/42 URS. 030.00.3100a 2 refs 93/42 URS. 030.00.4250a 93/42 URS. 031.00.4250a 93/42 URS. 031.06.4250a 93/42 URS. 034.00.4250a 4 refs 93/42 URS. 040.00.1500 2 refs 93/42 URS. 040.00.1500a 93/42 URS. 040.00.2000 93/42 URS. 040.00.3100 93/42 URS. 040.00.3100a 93/42 URS. 040.00.4250a 93/42 URS. 044.00.4250a 5 refs 93/42
I, IIa
93/42
Website
info@blazejewski.de
EUDAMED record
Report an error
Medacta FDA
EU representative : Medacta Italia srl (Italy)
Switzerland
251 others ACDF Driller Fixed Sterile - AO connection - L22 93/42 All-Suture Anchor Drill Size 1 - Ø1.8 - Long Sportsmed Drill bit / Reamer 3 refs Bayonet drill bit Ø3.2mm L15 Hip Drill bit 93/42 Bayonet drill bit Ø3.2mm L20 93/42 Bayonet drill bit Ø3.2mm L25 93/42 Bayonet drill bit Ø3.2mm L30 93/42 Bayonet drill bit Ø3.2mm L35 93/42 Bayonet drill bit Ø3.2mm L40 93/42 Bayonet drill bit Ø3.2mm L45 93/42 Bayonet drill bit Ø3.2mm L50 93/42 Bayonet drill bit Ø3.2mm L55 93/42 Bayonet drill bit Ø3.2mm L60 93/42 Bayonet drill bit Ø3.2mm L65 93/42 Bayonet drill bit Ø3.2mm L70 93/42 Bayonet drill bit Ø3.6mm L15 93/42 Bayonet drill bit Ø3.6mm L20 93/42 Bayonet drill bit Ø3.6mm L25 93/42 Bayonet drill bit Ø3.6mm L30 93/42 Bayonet drill bit Ø3.6mm L35 93/42 Bayonet drill bit Ø3.6mm L40 93/42 Bayonet drill bit Ø3.6mm L45 93/42 Bayonet drill bit Ø3.6mm L50 93/42 Bayonet drill bit Ø3.6mm L55 93/42 Bayonet drill bit Ø3.6mm L60 93/42 Bayonet drill bit Ø3.6mm L65 93/42 Bayonet drill bit Ø3.6mm L70 93/42 Bone drill Mbrace GT plate Ø3,2 93/42 Bone drill Mbrace GT plate Ø3,6 93/42 Cannulated Drill Ø10 mm Sportsmed Drill bit / Reamer 3 refs Cervical Drill bit Ø2.4mm_solid 93/42 Cervical Drill bit Ø2.9mm_cannulated 93/42 Cervical Drill bit Ø2.9mm_solid 93/42 Cervical Drill bit Ø3.3mm_cannulated 93/42 Cervical Drill bit Ø3.3mm_solid 93/42 Cervical Drill Ø2mm_solid 93/42 CONE-PUNTA PER ACETAB. 93/42 DL-Bone Drill bit Ø4.5 - AOConnection 93/42 DL-Bone Drill bit Ø4.5 - Zimmer Hall Connection 93/42 Drill Bit 12 mm AO Small Connection 93/42 Drill Bit 14 mm AO Small Connection 93/42 Drill Bit 16 mm AO Small Connection 93/42 Drill Bit 18 mm AO Small Connection 93/42 Drill Bit 20 mm AO Small Connection 93/42 Drill Bit 22 mm AO Small Connection 93/42 Drill bit for glenoid polyaxial screws Shoulder Motorized Drill Bit 3 refs Drill bit Ø3.2mm L130 93/42 Drill bit Ø3.2mm L220 – AO connection 93/42 Drill bit Ø3mm L220 93/42 Drill bit Ø3mm L300 93/42 Drill Ø2.4 Sportsmed Generic Drill 2 refs MectaScope - Rotating Sheath, 2 stopcock, W-L150mm Sportsmed Optical system (Sheath) MectaScope - Scope 30°, Ø4 L=18cm Autoclavable HD Sportsmed Optical system (Scope) 2 refs MySpine S1 Drill Ø2.7x20 Stop, AO-conn 93/42 MySpine S1 Drill Ø2.7x20 Stop, AO-conn STERILE 93/42 MySpine S1 Drill Ø2.7x20 Stop, STD-conn 93/42 MySpine S1 Drill Ø2.7x20 Stop,STD-conn STERILE 93/42 MySpine S1 Drill Ø2.7x25 Stop, AO-conn 93/42 MySpine S1 Drill Ø2.7x25 Stop, AO-conn STERILE 93/42 MySpine S1 Drill Ø2.7x25 Stop, STD-conn 93/42 MySpine S1 Drill Ø2.7x25 Stop,STD-conn STERILE 93/42 MySpine S1 Drill Ø2.7x30 Stop, AO-conn 93/42 MySpine S1 Drill Ø2.7x30 Stop, AO-conn STERILE 93/42 MySpine S1 Drill Ø2.7x30 Stop, STD-conn 93/42 MySpine S1 Drill Ø2.7x30 Stop,STD-conn STERILE 93/42 MySpine S1 Drill Ø2.7x35 Stop, AO-conn 93/42 MySpine S1 Drill Ø2.7x35 Stop, AO-conn STERILE 93/42 MySpine S1 Drill Ø2.7x35 Stop, STD-conn 93/42 MySpine S1 Drill Ø2.7x35 Stop,STD-conn STERILE 93/42 MySpine S1 Drill Ø2.7x40 Stop, AO-conn 93/42 MySpine S1 Drill Ø2.7x40 Stop, AO-conn STERILE 93/42 MySpine S1 Drill Ø2.7x40 Stop, STD-conn 93/42 MySpine S1 Drill Ø2.7x40 Stop,STD-conn STERILE 93/42 MySpine S1 Drill Ø2.7x45 Stop, AO-conn 93/42 MySpine S1 Drill Ø2.7x45 Stop, AO-conn STERILE 93/42 MySpine S1 Drill Ø2.7x45 Stop, STD-conn 93/42 MySpine S1 Drill Ø2.7x45 Stop,STD-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x20 Stop, AO-conn 93/42 MySpine T1L5 Drill Ø2.7x20 Stop, AO-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x20 Stop, STD-conn 93/42 MySpine T1L5 Drill Ø2.7x20 Stop, STD-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x25 Stop, AO-conn 93/42 MySpine T1L5 Drill Ø2.7x25 Stop, AO-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x25 Stop, STD-conn 93/42 MySpine T1L5 Drill Ø2.7x25 Stop, STD-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x30 Stop, AO-conn 93/42 MySpine T1L5 Drill Ø2.7x30 Stop, AO-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x30 Stop, STD-conn 93/42 MySpine T1L5 Drill Ø2.7x30 Stop, STD-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x35 Stop, AO-conn 93/42 MySpine T1L5 Drill Ø2.7x35 Stop, AO-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x35 Stop, STD-conn 93/42 MySpine T1L5 Drill Ø2.7x35 Stop, STD-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x40 Stop, AO-conn 93/42 MySpine T1L5 Drill Ø2.7x40 Stop, AO-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x40 Stop, STD-conn 93/42 MySpine T1L5 Drill Ø2.7x40 Stop, STD-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x45 Stop, AO-conn 93/42 MySpine T1L5 Drill Ø2.7x45 Stop, AO-conn STERILE 93/42 MySpine T1L5 Drill Ø2.7x45 Stop, STD-conn 93/42 MySpine T1L5 Drill Ø2.7x45 Stop, STD-conn STERILE 93/42 MySpine-C Drill Bit Cann. Ø2.9, depth markings 93/42 MySpine-C Drill Bit Cann. Ø2.9, Mech Stop 12mm 93/42 MySpine-C Drill Bit Cann. Ø2.9, Mech Stop 16mm 93/42 MySpine-C Drill Bit Cann. Ø2.9, Mech Stop 20mm 93/42 MySpine-C Drill Bit Cann. Ø2.9, Mech Stop 24mm 93/42 MySpine-C Drill Bit Cann. Ø2.9, Mech Stop 28mm 93/42 MySpine-C Drill Bit Cann. Ø3.3, depth markings 93/42 MySpine-C Drill Bit Cann. Ø3.3, Mech Stop 20mm 93/42 MySpine-C Drill Bit Cann. Ø3.3, Mech Stop 24mm 93/42 MySpine-C Drill Bit Cann. Ø3.3, Mech Stop 28mm 93/42 MySpine-C Drill Bit Solid Ø1.8, depth markings 93/42 MySpine-C Drill Bit Solid Ø1.8, depth markings STE 93/42 MySpine-C Drill Bit Solid Ø1.8, Mech Stop 12mm 93/42 MySpine-C Drill Bit Solid Ø1.8, Mech Stop 12mm STE 93/42 MySpine-C Drill Bit Solid Ø2.4, depth markings 93/42 MySpine-C Drill Bit Solid Ø2.4, depth markings STE 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 12mm 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 12mm STE 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 16mm 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 16mm STE 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 20mm 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 20mm STE 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 24mm 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 24mm STE 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 28mm 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 28mm STE 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 2mm 93/42 MySpine-C Drill Bit Solid Ø2.4, Mech Stop 2mm STE 93/42 MySpine-C Drill Bit Solid Ø2.9, depth markings 93/42 MySpine-C Drill Bit Solid Ø2.9, depth markings STE 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 12mm 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 12mm STE 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 16mm 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 16mm STE 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 20mm 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 20mm STE 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 24mm 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 24mm STE 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 28mm 93/42 MySpine-C Drill Bit Solid Ø2.9, Mech Stop 28mm STE 93/42 MySpine-C Drill Bit Solid Ø3.3, depth markings 93/42 MySpine-C Drill Bit Solid Ø3.3, depth markings STE 93/42 MySpine-C Drill Bit Solid Ø3.3, Mech Stop 20mm 93/42 MySpine-C Drill Bit Solid Ø3.3, Mech Stop 20mm STE 93/42 MySpine-C Drill Bit Solid Ø3.3, Mech Stop 24mm 93/42 MySpine-C Drill Bit Solid Ø3.3, Mech Stop 24mm STE 93/42 MySpine-C Drill Bit Solid Ø3.3, Mech Stop 28mm 93/42 MySpine-C Drill Bit Solid Ø3.3, Mech Stop 28mm STE 93/42 NextAR Spine Solid Drill Ø2,4mm depth 20mm 93/42 NextAR Spine Solid Drill Ø2,4mm depth 25mm 93/42 NextAR Spine Solid Drill Ø2,4mm depth 30mm 93/42 NextAR Spine Solid Drill Ø2,4mm depth 35mm 93/42 NextAR Spine Solid Drill Ø2,4mm depth 40mm 93/42 NextAR Spine Solid Drill Ø2,4mm depth 45mm 93/42 NextAR Spine Solid Drill Ø2,4mm depth 50mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 20mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 25mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 30mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 35mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 40mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 45mm 93/42 NextAR Spine Solid Drill Ø2,7mm depth 50mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 20mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 25mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 30mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 35mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 40mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 45mm 93/42 NextAR Spine Solid Drill Ø3,2mm depth 50mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 20mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 25mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 30mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 35mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 40mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 45mm 93/42 NextAR Spine Solid Drill Ø3,6mm depth 50mm 93/42 Occipital cardan drill bit ø2.6mm with AO connecti 93/42 Occipital drill bit ø2.6mm with AO connection 93/42 Omega Drill Ø2.7mm AO-conn 93/42 Omega Drill Ø2.7mm AO-conn STERILE 93/42 Omega Drill Ø2.7mm STD-conn 93/42 Omega Drill Ø2.7mm STD-conn STERILE 93/42 Sharp Drill S1 Ø2.7x20mm Stop 93/42 Sharp Drill S1 Ø2.7x20mm Stop STERILE 93/42 Sharp Drill S1 Ø2.7x25mm Stop 93/42 Sharp Drill S1 Ø2.7x25mm Stop STERILE 93/42 Sharp Drill S1 Ø2.7x30mm Stop 93/42 Sharp Drill S1 Ø2.7x30mm Stop STERILE 93/42 Sharp Drill S1 Ø2.7x35mm Stop 93/42 Sharp Drill S1 Ø2.7x35mm Stop STERILE 93/42 Sharp Drill S1 Ø2.7x40mm Stop 93/42 Sharp Drill S1 Ø2.7x40mm Stop STERILE 93/42 Sharp Drill S1 Ø2.7x45mm Stop 93/42 Sharp Drill S1 Ø2.7x45mm Stop STERILE 93/42 Sharp Drill T1L5 Ø2.7x20mm Stop 93/42 Sharp Drill T1L5 Ø2.7x20mm Stop STERILE 93/42 Sharp Drill T1L5 Ø2.7x25mm Stop 93/42 Sharp Drill T1L5 Ø2.7x25mm Stop STERILE 93/42 Sharp Drill T1L5 Ø2.7x30mm Stop 93/42 Sharp Drill T1L5 Ø2.7x30mm Stop STERILE 93/42 Sharp Drill T1L5 Ø2.7x35mm Stop 93/42 Sharp Drill T1L5 Ø2.7x35mm Stop STERILE 93/42 Sharp Drill T1L5 Ø2.7x40mm Stop 93/42 Sharp Drill T1L5 Ø2.7x40mm Stop STERILE 93/42 Sharp Drill T1L5 Ø2.7x45mm Stop 93/42 Sharp Drill T1L5 Ø2.7x45mm Stop STERILE 93/42 Sharp Drill Ø2.7mm AO-conn MySpine comp. 93/42 Sharp Drill Ø2.7mm AO-conn MySpine comp.STERILE 93/42 Sharp Drill Ø2.7x200mm 93/42 Sharp Drill Ø2.7x200mm STERILE 93/42 Sterile Cervical Drill bit Ø2.4mm_solid 93/42 Sterile Cervical Drill bit Ø2.9mm_solid 93/42 Sterile Cervical Drill bit Ø3.3mm_solid 93/42 Sterile Cervical Drill Ø2mm_solid 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 20mm 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 25mm 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 30mm 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 35mm 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 40mm 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 45mm 93/42 Sterile NextAR Spine Solid Drill Ø2,4mm depth 50mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 20mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 25mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 30mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 35mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 40mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 45mm 93/42 Sterile NextAR Spine Solid Drill Ø2,7mm depth 50mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 20mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 25mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 30mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 35mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 40mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 45mm 93/42 Sterile NextAR Spine Solid Drill Ø3,2mm depth 50mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 20mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 25mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 30mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 35mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 40mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 45mm 93/42 Sterile NextAR Spine Solid Drill Ø3,6mm depth 50mm 93/42 Sterile OC cardan drill bit Ø2.6mm_AO conn 93/42 Sterile OC straight drill bit Ø2.6mm_AO conn 93/42 Ø3.2 Guide wire 305mm - Drill bit 93/42 Ø3.2 Guide wire 305mm - Drill bit Sterile 93/42 Ø3.2 Guide wire 450mm - Drill bit 93/42 Ø4,4 mm drill 93/42 Ø5.5 Cannulated drill bit 93/42 Ø6,4 mm drill 93/42 Ø7.5 Cannulated drill bit 93/42
IIa
MDR, 93/42
Website
info@medacta.ch
EUDAMED record
Report an error
Magstim FDA
EU representative : MPS Medical Product Service GmbH (Germany) and 1 other
United Kingdom (ex Northern Ireland), United States
247 others
I, IIa, IIb
MDR, 93/42
Website
regulatorymagstim@welcony.com
EUDAMED record
Report an error
Friendshipmedical FDA
EU representative : Friendship Europe ApS (Denmark)
China
217 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Nakanishi FDA
EU representative : NSK Europe GmbH (Germany)
Japan
210 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Arcmed
Türkiye
185 others
IIb
93/42
Website
EUDAMED record
Report an error
Aygün Cerrahi Aletler Sanayi ve Ticaret Anonim Şirketi
Türkiye
162 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shenzhen Comen Medical Instruments FDA
EU representative : Lotus NL B.V. (Netherlands)
China
162 others
I, IIa, IIb, III
MDR, 93/42
EUDAMED record
Report an error
Atmosmed FDA
Germany
160 others ATMOS C 161 Aspirator / Serres® Suction unit, tracheal 93/42 ATMOS C 161 Battery / DDS Suction unit, tracheal 93/42 ATMOS C 161 Battery / Medi-Vac® Suction unit, tracheal 93/42 ATMOS C 161 Battery / Receptal® 1.5 l Suction unit, tracheal 93/42 ATMOS C 161 Battery / Serres® Suction unit, tracheal 93/42 ATMOS C 21 Economy - function column (115 V~) 93/42 ATMOS C 21 Economy - function column (127 V~) 93/42 ATMOS C 21 Economy - function column (230 V~) 93/42 ATMOS C 261 Aspirator / DDS Suction unit, tracheal 93/42 ATMOS C 261 Aspirator / Medi-Vac® Suction unit, tracheal 93/42 ATMOS C 261 Aspirator / Receptal® 1.5 l Suction unit, tracheal 93/42 ATMOS C 261 Aspirator / Serres® Suction unit, tracheal 93/42 ATMOS C 31 Economy - function column (115 V~) 93/42 ATMOS C 31 Economy - function column (127 V~) 93/42 ATMOS C 31 Economy - function column (230 V~) 93/42 ATMOS C 361 mobile (1 x 1.5 l canister) Suction unit, surgical 93/42 ATMOS C 361 mobile (1 x 3 l canister) Suction unit, surgical 93/42 ATMOS C 361 mobile with standard rail Suction unit, surgical 93/42 ATMOS C 361 portable (1 x 1,5 l canister) Suction unit, surgical 93/42 ATMOS C 361 portable (1 x 3 l canister) Suction unit, surgical 93/42 ATMOS C 361 portable with standard rail Suction unit, surgical 93/42 ATMOS C 361 Suction unit, surgical 93/42 ATMOS C 451 93/42 ATMOS C 451 mobile (2 x 1.5 l canister) 93/42 ATMOS C 451 mobile (2 x 1.5 l canister) installed Suction unit, surgical 93/42 ATMOS C 451 mobile (2 x 3 l canister) Suction unit, surgical 93/42 ATMOS C 451 mobile (2 x 3 l canister), installed Suction unit, surgical 93/42 ATMOS C 451 mobile (2 x 5 l canister) 93/42 ATMOS C 451 mobile (2 x 5 l canister), installed Suction unit, surgical 93/42 ATMOS C 451 mobile with standard rail 93/42 ATMOS C 451 mobile with standard rail, installed Suction unit, surgical 93/42 ATMOS C 451 portable (1 x 1.5 l canister) 93/42 ATMOS C 451 portable (1 x 3 l canister) Suction unit, surgical 93/42 ATMOS C 451 portable with standard rail 93/42 ATMOS Cam Cameras, Video, Endoscope 2 refs ATMOS HL 21 LED Headlights 3 refs ATMOS i View 21 2 refs ATMOS i View 21 COLPO 2 refs ATMOS i View 21 PRO 2 refs ATMOS Laryngoscope HD 70°, Ø 10 mm, L = 190 mm Endoscope, rigid 3 refs ATMOS LC 27 / DDS Suction unit, tracheal 93/42 ATMOS LC 27 / DDS Universal Suction unit, tracheal 93/42 ATMOS LC 27 / Medi-Vac® Suction unit, tracheal 93/42 ATMOS LC 27 / Serres® Suction unit, tracheal 93/42 ATMOS LC 27 Battery / DDS Suction unit, tracheal 93/42 ATMOS LC 27 Battery / DDS Universal Suction unit, tracheal 93/42 ATMOS LC 27 Battery / Medi-Vac® Suction unit, tracheal 93/42 ATMOS LC 27 Battery / Serres® Suction unit, tracheal 93/42 ATMOS LS 21 LED 3 refs ATMOS LS 31 LED ATMOS Record 55 DDS (2 x 3 l canister) 93/42 ATMOS Record 55 DDS (2 x 5 l canister) 93/42 ATMOS Record 55 DDS - 230 V~ 93/42 ATMOS Record 55 with standard rail - 230 V~ Suction unit, surgical 93/42 ATMOS S 351 NATAL mobile with foot control, 230 V Vacuum extractor, foetal 93/42 ATMOS S 351 NATAL mobile, 230 V Vacuum extractor, foetal 93/42 ATMOS S 351 NATAL – basic set, 230 V (Medi-Vac®) Vacuum extractor, foetal 93/42 ATMOS S 351 NATAL – basic set, 230 V (Serres®) Vacuum extractor, foetal 93/42 ATMOS S 351 NATAL – basic set, 230 V Vacuum extractor, foetal 93/42 ATMOS S 351 NATAL, 230 V Vacuum extractor, foetal 93/42 ATMOS S 351 OT (1.5 l canister), 230 V Suction unit, surgical 93/42 ATMOS S 351 OT mobile (2 x 3 l canister), 230 V Suction unit, surgical 93/42 ATMOS S 351 OT mobile, 230 V Suction unit, surgical 93/42 ATMOS S 351 OT – basic set, 230 V (Medi-Vac®) Suction unit, surgical 93/42 ATMOS S 351 OT – basic set, 230 V (Serres®) Suction unit, surgical 93/42 ATMOS S 351 OT – basic set, 230 V Suction unit, surgical 93/42 ATMOS S 351 OT, 230 V Suction unit, surgical 93/42 ATMOS S 61 CORIAN instruments Cabinets, Instrument 3 refs ATMOS S 61 Servant ENT workstation (230 V~) 93/42 ATMOS S 61 Servant ENT workstation (115 V~) 93/42 ATMOS S 61 Servant ENT workstation (127 V~) 93/42 ATMOS S 61 Servant instruments Cabinets, Instrument 3 refs ATMOS S 61 Servant vision Cabinets, Instrument ATMOS Scope Nasopharyngoscopes 3 refs ATMOS Strobo 21 LED Light Sources, Flash 2 refs ATMOS Twin Record 55 DDS – 230 V~ 93/42 ATMOS Twin Record 55 with standard rail – 230 V~ 93/42 BORA UP 2080 / Sep. Fl. Asp./ portable/1x1 l Suction unit, surgical 93/42 BORA UP 2080 / Sep. Fl. Asp./ trolley/1x3 l Suction unit, surgical 93/42 BORA UP 2080 230V 50/60 Hz Suction unit, surgical 93/42 BORA UP 2080 OP / Sur. Asp./ trolley/2x3 l Suction unit, surgical 93/42 BORA UP 2080 OP / Sur. Asp./ trolley/2x4 l/ PC Suction unit, surgical 93/42 BORA UP 2080 OP / Sur. Asp./ trolley/2x4 l/ PSU Suction unit, surgical 93/42 BORA UP 2080 OP 230V 50/60 Hz Suction unit, surgical 93/42 Connection hose-A (orange-orange), 3 m Connection hose-A (orange-orange), 5 m Connection hose-A (standard-orange), 5 m Connection hose-D (orange-orange), 3 m Connection hose-D (orange-orange), 5 m Connection hose-D (orange-standard), 5 m Connection hose-D (standard-standard), 3 m Connection hose-D (standard-standard), 5 m Cuff 2XL, orange connector Cuff 2XL, standard connector Cuff 2XS, orange connector Cuff 2XS, standard connector Cuff 3XL, orange connector Cuff 3XL, standard connector Cuff L, orange connector Cuff L, standard connector UT 1321-L Cuff M, orange connector Cuff M, standard connector UT 1321-M Cuff S, orange connector Cuff S, standard connector UT 1321-S Cuff XL, orange connector Cuff XL, standard connector Cuff XS, orange connector Cuff XS, standard connector Disposable cuff 2XL, orange connector, 10 pcs. 3 refs FINA AIR B 800 Equipment rail Suction unit, gas powered 93/42 FINA AIR B 800 Equipment rail, top-view gauge Suction unit, gas powered 93/42 FINA AIR B 800 Top view gauge, screw connection Suction unit, gas powered 93/42 FINA AIR B 800 Wall DIN Suction unit, gas powered 93/42 FINA AIR B 800 Wall MEDAP Suction unit, gas powered 93/42 FINA AIR D 150 Equipment rail Suction unit, gas powered 93/42 FINA AIR D 150 Wall DIN Suction unit, gas powered 93/42 FINA AIR P 350 Equipment rail Suction unit, gas powered 93/42 FINA AIR P 350 Wall DIN Suction unit, gas powered 93/42 FINA AIR T 50 Equipment rail Suction unit, gas powered 93/42 FINA AIR T 50 Wall DIN Suction unit, gas powered 93/42 FINA Mobile Aspiration Unit / AIR/ 2x3 l / ISO Suction unit, gas powered 93/42 FINA Mobile Aspiration Unit / VAC / 2x3 l / ISO Suction unit, vacuum 93/42 FINA Mobile Aspiration Unit Basic Equipment AIR Suction unit, gas powered 93/42 FINA Mobile Aspiration Unit Basic Equipment VAC Suction unit, vacuum 93/42 FINA Portable Aspiration Unit / AIR / 2x1 l / ISO Suction unit, gas powered 93/42 FINA Portable Aspiration Unit / VAC / 2x1 l / ISO Suction unit, vacuum 93/42 FINA Portable Aspiration Unit Basic Equip / AIR Suction unit, gas powered 93/42 FINA Portable Aspiration Unit Basic Equip / VAC Suction unit, vacuum 93/42 FINA VAC B 800 Equipment rail Suction unit, vacuum 93/42 FINA VAC B 800 Equipment rail, top view gauge Suction unit, vacuum 93/42 FINA VAC B 800 GT/SS Fresenius Suction unit, vacuum 93/42 FINA VAC B 800 Top-view gauge, screw connection Suction unit, vacuum 93/42 FINA VAC B 800 Wall DIN Suction unit, vacuum 93/42 FINA VAC B 800 Wall MEDAP Suction unit, vacuum 93/42 FINA VAC D 150 Equipment rail Suction unit, vacuum 93/42 FINA VAC D 150 Wall DIN Suction unit, vacuum 93/42 FINA VAC P 350 Equipment rail Suction unit, vacuum 93/42 FINA VAC P 350 Wall DIN Suction unit, vacuum 93/42 FINA VAC T 50 Equipment rail 93/42 FINA VAC T 50 Wall DIN Suction unit, vacuum 93/42 S AIR B 800 Equipment rail 93/42 S AIR B 800 Screw connection 93/42 S AIR B 800 Wall BS (Great Britain) 93/42 S AIR B 800 Wall DIN 93/42 S AIR B 800 Wall MEDAP 93/42 S AIR B 800 Wall NF (France) 93/42 S AIR Mobile Aspiration Unit / AIR/ 2x3 l / ISO 93/42 S AIR Mobile Aspiration Unit / AIR/ 2x4 l/ PC/ ISO 93/42 S AIR Mobile Aspiration Unit / AIR/ 2x4 l/PSU/ ISO 93/42 S AIR Mobile Aspiration Unit Basic Equipment AIR HM57525695 93/42 S AIR Portable Aspiration Unit / AIR / 2x1 l / ISO 93/42 S AIR Portable Aspiration Unit Basic Equip / AIR 93/42 TRACHEOFIRST® PRO 93/42 TRACHEOPORT® PRO 93/42 TWISTA SP 1070 230V/50-60 Hz Suction unit, surgical 93/42 TWISTA SP 1070 Complete Unit / 2 x 3 l Suction unit, surgical 93/42 TWISTA SP 1070 Complete Unit / 2 x 4 l / PC Suction unit, surgical 93/42 TWISTA SP 1070 Complete Unit / 2 x 4 l / PSU Suction unit, surgical 93/42 BORA UP 2080 OP 115V/60 Hz Suction unit, surgical 93/42 (no longer marketed) TWISTA SP 1070 127V/60Hz Suction unit, surgical 93/42 (no longer marketed)
I, IIa
MDR, 93/42
Website
info@atmosmed.de
EUDAMED record
Report an error
Unintech
Germany
153 others
I, IIa
MDR, 93/42
info@unintech.de
EUDAMED record
Report an error
Diaswiss FDA
EU representative : DFS-Diamon GmbH (Germany)
Switzerland
150 others Carbide finishing bur Diacarb RA 2 refs 93/42 Carbide finishing bur Diacarb RA ASSD 93/42 Dental Crown Cutter FG crown cutter carbide 93/42 Diaflex Mini 93/42 Diasoft Crown Cutter 2 refs 93/42 DIASWISS Bone Cutter Allport FG XL 2 refs 93/42 DIASWISS Bone Cutter Bone cutter carbide HP 2 refs 93/42 DIASWISS Bone Cutter Bone cutter carbide Tin-coated 154T FG 93/42 DIASWISS Bone Cutter Bone cutter carbide Tin-coated 162AT F 93/42 DIASWISS Bone Cutter Bone cutter carbide Tin-coated 162AT H 93/42 DIASWISS Bone Cutter Bone cutter carbide Tin-coated 162T HP 93/42 DIASWISS Bone Cutter Bone cutter carbide Tin-coated 262T FG 93/42 DIASWISS Bone Cutter Bone cutter carbide Tin-coated 415AT F 2 refs 93/42 DIASWISS Bone Cutter C141 Allport bone cutter 6 refs 93/42 DIASWISS Bone Cutter C141 X Allport bone cutter 4 refs 93/42 DIASWISS Bone Cutter C151 bone cutter 93/42 DIASWISS Bone Cutter C151 bone cutter carbide bur 93/42 DIASWISS Bone Cutter C152 bone cutter 2 refs 93/42 DIASWISS Bone Cutter C161 Lindemann bone cutter 2 refs 93/42 DIASWISS Bone Cutter C161 Lindemann bone cutter carbide bur 93/42 DIASWISS Bone Cutter C162 Lindemann bone cutter 2 refs 93/42 DIASWISS Bone Cutter C168 bone cutter 93/42 DIASWISS Bone Cutter C687 bone cutter 93/42 DIASWISS Bone Cutter C687 X carbide bone cutter RA L 93/42 DIASWISS Bone Cutter CB255A bone cutter 2 refs 93/42 DIASWISS Bone Cutter DIA-Z 93/42 DIASWISS Bone Cutter Electroplated diamond HP C 141D 3 refs 93/42 DIASWISS Bone Cutter FG XL Endo carbide C389 diamond coated 2 refs 93/42 DIASWISS Bone Cutter RF 161 Lindemann bone cutter 93/42 DIASWISS Bone Cutter RF 162 Lindemann bone cutter 93/42 DIASWISS Bone Cutter RF 166 Lindemann bone cutter 93/42 DIASWISS Bone Cutter RF 167 Lindemann bone cutter 93/42 DIASWISS Bone Cutter RF 407 Lindemann bone cutter type I 93/42 DIASWISS Bone Cutter RF 410 Lindemann bone cutter type III 93/42 DIASWISS Bone Cutter RF 411 bone cutter diamond coated 5 refs 93/42 DIASWISS Bone Cutter Sugical burs G 411D 014 93/42 DIASWISS Diamond CA Electroplated diamond RA 368 021 93/42 DIASWISS Diamond CA Electroplated diamond RA 368 023 93/42 DIASWISS Diamond CA Electroplated diamond RA 801 010 93/42 DIASWISS Diamond CA Electroplated diamond RA 801 014 93/42 DIASWISS Diamond CA Electroplated diamond RA 801 016 93/42 DIASWISS Diamond CA Electroplated diamond RA 801 018 93/42 DIASWISS Diamond CA Electroplated diamond RA 801 023 93/42 DIASWISS Diamond CA Electroplated diamond RA 801 029 93/42 DIASWISS Diamond CA Electroplated diamond RA 805 014 93/42 DIASWISS Diamond CA Electroplated diamond RA 805 016 93/42 DIASWISS Diamond CA Electroplated diamond RA 808 018 93/42 DIASWISS Diamond CA Electroplated diamond RA 810 040 93/42 DIASWISS Diamond CA Electroplated diamond RA 818 040 93/42 DIASWISS Diamond CA Electroplated diamond RA 835 008 93/42 DIASWISS Diamond CA Electroplated diamond RA 835 010 93/42 DIASWISS Diamond CA Electroplated diamond RA 835 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 835 016 93/42 DIASWISS Diamond CA Electroplated diamond RA 837 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 837 014 93/42 DIASWISS Diamond CA Electroplated diamond RA 845 010 93/42 DIASWISS Diamond CA Electroplated diamond RA 845 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 850 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 850 014 93/42 DIASWISS Diamond CA Electroplated diamond RA 850 016 93/42 DIASWISS Diamond CA Electroplated diamond RA 857 014 93/42 DIASWISS Diamond CA Electroplated diamond RA 859 016 93/42 DIASWISS Diamond CA Electroplated diamond RA 860 016 93/42 DIASWISS Diamond CA Electroplated diamond RA 862 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 863 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 881 012 93/42 DIASWISS Diamond CA Electroplated diamond RA 881 014 93/42 DIASWISS Diamond CA Electroplated diamond RA C862 014 93/42 DIASWISS Diamond CA RA diamond standard 2 refs 93/42 DIASWISS Diamond CA RA diamond standard 839 014 93/42 DIASWISS Diamond FG FG crown cutter zirconia diamond bur 3 refs 93/42 DIASWISS Diamond FG FG diamond coarse 175 refs 93/42 DIASWISS Diamond FG FG diamond coarse 4mm 93/42 DIASWISS Diamond FG FG diamond depth marker conical 8° 1.0 93/42 DIASWISS Diamond FG FG diamond depth marker conical 8° 1.5 93/42 DIASWISS Diamond FG FG diamond depth marker conical 8° 1.8 93/42 DIASWISS Diamond FG FG diamond depth marker conical 8° 2.2 93/42 DIASWISS Diamond FG FG diamond depth marker conical 8° 2.4 93/42 DIASWISS Diamond FG FG diamond depth marker cylindrical 1.0 93/42 DIASWISS Diamond FG FG diamond depth marker cylindrical 1.5 93/42 DIASWISS Diamond FG FG diamond depth marker cylindrical 2.0 93/42 DIASWISS Diamond FG FG diamond depth marker cylindrical 2.2 93/42 DIASWISS Diamond FG FG diamond depth marker cylindrical 2.4 93/42 DIASWISS Diamond FG FG diamond fein 93/42 DIASWISS Diamond FG FG diamond fine 130 refs 93/42 DIASWISS Diamond FG FG diamond medium 93/42 DIASWISS Diamond FG FG diamond short 39 refs 93/42 DIASWISS Diamond FG FG diamond standard 239 refs 93/42 DIASWISS Diamond FG FG diamond supercoarse 100 refs 93/42 DIASWISS Diamond FG FG diamond superfine 65 refs 93/42 DIASWISS Diamond FG FG diamond turbo standard 3 refs 93/42 DIASWISS Diamond FG FG diamond turbo supercoarse 2 refs 93/42 DIASWISS Diamond FG FG diamond ultrafine 9 refs 93/42 DIASWISS Diamond FG FG microprep fine 8 refs 93/42 DIASWISS Diamond FG FG microprep standard 16 refs 93/42 DIASWISS Diamond FG FG prep diamond fine 3 refs 93/42 DIASWISS Diamond FG FG prep diamond supercoarse 7 refs 93/42 DIASWISS Diamond FG FG reducer coarse 2 refs 93/42 DIASWISS Diamond FG FG reducer standard 3 refs 93/42 DIASWISS Diamond FG FG trepanation instrument zirconia 93/42 DIASWISS Diamond FG FG zirconia diamond 368 93/42 DIASWISS Diamond FG FG zirconia diamond 379 93/42 DIASWISS Diamond FG FG zirconia diamond 830L 93/42 DIASWISS Diamond FG FG zirconia diamond 877K 93/42 DIASWISS Diamond FG FG zirconia diamond fine 368 93/42 DIASWISS Diamond FG FG zirconia diamond fine 379 93/42 DIASWISS Diamond FG FG zirconia diamond fine 877K 93/42 Diazircon 93/42 Endodontic Access Bur FG diamond coarse Endo 93/42 Endodontic Guttapercha Separator ThermaSoft 801 0,8 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801 1,2 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801 1,4 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801 1,6 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801L 1,0 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801L 1,2 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801L 1,6 mm 93/42 Endodontic Guttapercha Separator ThermaSoft 801L 2,1 mm 93/42 FG Diacarb carbide crown cutter 10 refs 93/42 FG Diacarb crown cutter 93/42 FG Diacarb finishing bur 30 refs 93/42 FG Diacarb finishing bur ASSD 93/42 FG L Swiss Goldie standard 4 refs 93/42 FG Swiss Goldie coarse 32 refs 93/42 FG Swiss Goldie coarse diamond bur 11 refs 93/42 FG Swiss Goldie fine 23 refs 93/42 FG Swiss Goldie standard 38 refs 93/42 FG Swiss Goldie superfine 13 refs 93/42 Perio diamond fine 2 refs 93/42 Perio diamond standard 3 refs 93/42 Perio diamond superfine 3 refs 93/42 rootEX Pilot Drill Drill Root-Ex long 1,1 mm single 93/42 rootEX Pilot Drill Drill Root-Ex long 1,3 mm single 93/42 rootEX Pilot Drill Drill Root-Ex long 1,6 mm single 93/42 rootEX Pilot Drill Drill Root-Ex short 1,1 mm 93/42 rootEX Pilot Drill Drill Root-Ex short 1,8 mm single 93/42 rootEX Pilot Drill rootEX drill 0,8 mm, pu: 6 pcs 93/42 rootEX Pilot Drill rootEX drill 1,1 mm, pu: 6 pcs 93/42 rootEX Pilot Drill rootEX drill 1,3 mm, pu: 6 pcs 93/42 rootEX Pilot Drill rootEX drill 1,8 mm, pu: 6 pcs 93/42 rootEX Pilot Drill rootEX drill short shank 0,8 mm 6 93/42 rootEX Pilot Drill rootEX drill short shank 1,3 mm 6 93/42 rootEX Pilot Drill rootEX drill short shank 1,6 mm, pu: 6 93/42 rootEX Root Tip Extractor rootEX instrument long 0,8 mm single 93/42 rootEX Root Tip Extractor rootEX instrument long 0,8 mm, pu: 6 p 93/42 rootEX Root Tip Extractor rootEX instrument long 1,3 mm single 93/42 rootEX Root Tip Extractor rootEX instrument long 1,8 mm single 93/42 rootEX Root Tip Extractor rootEX instrument long 1,8 mm, pu: 6 p 93/42 rootEX Root Tip Extractor rootEX instrument short 0,8 mm single 93/42 rootEX Root Tip Extractor rootEX instrument short 1,3 mm single 93/42 rootEX Root Tip Extractor rootEX instrument short 1,8 mm single 93/42
IIa
93/42
Website
mail@diaswiss.ch
EUDAMED record
Report an error
Nonin FDA
EU representative : MPS Medical Product Service GmbH (Germany)
United States
Avant Pulse Oximeter System MODEL 9600, 8000AA, PCS-EU 93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA, PCS-US 93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA-2, PCS-EU 93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA-2, PCS-US 93/42 Avant Pulse Oximeter System MODEL 9600, 8000J, PCS-EU 93/42 147 others Avant Pulse Oximeter System MODEL 9600, 8000SL, PCS-US 93/42 Avant Pulse Oximeter System MODEL 9600, 8000SL-3, PCS-US 93/42 Avant Pulse Oximeter System MODEL 9600, 8000SM, PCS-EU 93/42 Avant Pulse Oximeter System MODEL 9600, 8000SM-3, PCS-EU 93/42 Avant Pulse Oximeter System MODEL 9600, 8000SS-3, PCS-EU 93/42 Avant Pulse Oximeter System MODEL 9600, 8008J, PCS-EU 93/42 Avant Pulse Oximeter System MODEL 9600, PULSE OXIMETER HC 93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000AA-3, PCS-US 93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000SL-3, PCS-US 93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000SM-3, PCS-US 93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000AA-3, PCS-EU 93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000AA-3, PCS-US 93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000SM-3, PCS-UK 93/42 Fiber Optic Pulse Oximeter MODEL 7500FO, PCS-JP 93/42 Fiber Optic Pulse Oximeter MODEL 7500FO, PULSE OXIMETER, INMETRO 93/42 Fingertip Pulse Oximeter MODEL 9590, OXIMETER - BLACK, INMETRO 93/42 FINGERTIP PULSE OXIMETER with 9590 BLUE, OXIMETER MODEL 9590 BLUE, OXIMETER 93/42 FINGERTIP PULSE OXIMETER with 9590 RED, OXIMETER MODEL 9590 RED, OXIMETER 93/42 FINGERTIP PULSE OXIMETER, MODEL 9590 BLK, OXIMETER 93/42 Flexiwrap Adhesive Strips 70276, MODEL 8000JFW ADULT FLEXW DISP 93/42 LP XPOD 22370, XPOD LP - 8000SM SENSOR SET 93/42 LP XPOD 22380, XPOD LP - 7000A SENSOR SET 93/42 LP XPOD 36944, XPOD LP - 8000SM-3M SENSOR SET 93/42 Model 2500 PKG ASSY, 2500, CHINA 93/42 MODEL 2500, PALMSAT HANDHELD OXIMETER 93/42 MODEL 3011LP XPOD, OXIMETER DF1 2M W/O CONN 93/42 MODEL 3011LP XPOD, OXIMETER DF1 W/O CONN 93/42 MODEL 3012LP, LP XPOD 93/42 MODEL 3017LP XPOD, OXIMETER DF7 W/OUT CONN 93/42 MODEL 3150SC, WRIST-OX2 USB COMM CABLE 93/42 Model 3231 USB OEM External Pulse Oximeter 93/42 MODEL 7500, 8000SL, PCS-USPulse Oximeter System 93/42 Model 9550 Onyx II Fingertip Pulse Oximeter System 6515-01-535-2728, OXIMETER, PULSE, FINGER W/CASE 93/42 MODEL 9590, OXIMETER BLUE 93/42 MODEL 9590, OXIMETER RED 93/42 MODEL LP XPOD, ALICE NIGHTONE, NONIN SPO2 CAB 93/42 MODEL LP XPOD, NONIN, SPO2 CABLE, ALICE 93/42 MODEL X-100H, HUB 93/42 MODEL X-100HH, HUB HOLSTER 93/42 Multi-Sensing Oximetry Signal Processor MODEL 3500SP, DEVELOPMENT KIT 93/42 NoninConnect Elite Finger Pulse Oximeter MODEL 3240, NONINCONNECT ELITE 93/42 OEM External Pulse Oximeter MODEL 3231 93/42 OEM External Wireless Pulse Oximeter MODEL 3230, V2.7 AU/NZ 93/42 OEM External Wireless Pulse Oximeter PKG ASSY, 3230, CONTINUA 93/42 Onyx II Fingertip Pulse Oximeter MODEL 9550, PULSE OXIMETER 93/42 Onyx® Vantage 9590 Fingertip Pulse Oximeter MODEL 9590, OXIMETER BLACK 93/42 Onyx® Vantage 9590 Fingertip Pulse Oximeter MODEL 9590, OXIMETER PURPLE 93/42 PalmSAT Charger MODEL 2500C, PCS-JP 93/42 PalmSAT Charger MODEL 2500C, PULSE OXIMETER CHARGER, INMETRO 93/42 PALMSAT HANDHELD OXIMETER MODEL 2500, 8000Q2 93/42 PALMSAT HANDHELD OXIMETER MODEL 2500A CFG, PULSE OXIMETER W/ALARMS 93/42 PALMSAT HANDHELD OXIMETER MODEL 2500A, PULSE OXIMETER W/ALARMS 93/42 PALMSAT HANDHELD OXIMETER with 8000J sensor MODEL 2500, 8000J 93/42 PALMSAT HANDHELD OXIMETER with 8001J sensor MODEL 2500, 8001J 93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AA-2 93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AA-3 93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AP 93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AP-3 93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000J-3 93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000SL-3 93/42 PalmSat Pulse Oximeter System MODEL 2500, PALMSAT HANDHELD OXIMETER CONFIGUREABLE 93/42 PalmSat Pulse Oximeter System MODEL 2500A INMETRO, 8000SM-3 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000AA-2 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000AP-3 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000J 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000Q2 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SL 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SL-3 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SS 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SS-3 93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8008J 93/42 Pulse Oximeter System MODEL 2500, 8000SS-3 93/42 Pulse Oximeter System MODEL 7500 INMETRO, 8000SM-3 93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8000AA-3M, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, 8000AP, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, 8000AP, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000AP-3, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, 8000J, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000Q2, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8000SL, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000SL-3, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8000SM, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8000SS, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000SS, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-UK 93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-US 93/42 Pulse Oximeter System MODEL 7500, 8008J, PCS-EU 93/42 Pulse Oximeter System MODEL 7500, 8008J, PCS-US 93/42 Pulse Oximeter System MODEL 7500, NO SENSOR, PCS-AU 93/42 Pulse Oximeter System MODEL 7500, PULSE OXIMETER HC 93/42 Pulse Oximeter with Waveform MODEL 9700, 8000AA, PCS-EU 93/42 SenSmart X-100 MODEL X-100SP-1, SENSMART SIGNAL PROCESSOR 93/42 SenSmart X-100 MODEL X-100SP-2, SENSMART SIGNAL PROCESSOR 93/42 SenSmart X-100 MODEL X-100SP-3, SENSMART SIGNAL PROCESSOR 93/42 SenSmart X-100 MODEL X-100SP-4, SENSMART SIGNAL PROCESSOR 93/42 SenSmart X-100 MODEL X-100SP-6, SENSMART SIGNAL PROCESSOR 93/42 Universal Oximetry System MODEL X-100, INT, PCS-EU, ENG 93/42 Universal Oximetry System MODEL X-100, INT, PCS-EU, NONE 93/42 Universal Oximetry System MODEL X-100, INT, PCS-UK, NONE 93/42 Universal Oximetry System MODEL X-100, INT, PCS-UK, NONE, ENG 93/42 Universal Oximetry System MODEL X-100, INT, PCS-US, ENG 93/42 Universal Oximetry System MODEL X-100, LONG, PCS-EU, NONE, ENG 93/42 Universal Oximetry System MODEL X-100, LONG, PCS-UK, NONE, ENG 93/42 Universal Oximetry System MODEL X-100, LONG, PCS-US, JAPAN, ENG 93/42 Universal Oximetry System MODEL X-100, LONG, PCS-US, NONE, ENG 93/42 Universal Oximetry System PKG ASSY, X-100SP-1/INT-100 93/42 Universal Oximetry System PKG ASSY, X-100SP-2/INT-100 93/42 Universal Oximetry System PKG ASSY, X-100SP-3/INT-100 93/42 Universal Oximetry System PKG ASSY, X-100SP-4/INT-100 93/42 Universal Oximetry System PKG ASSY, X-100SP-5/INT-100 93/42 Universal Oximetry System PKG ASSY, X-100SP-6/INT-100 93/42 Vital Signs Monitor Capnography/Pulse Oximeter MODEL LS1-9R, 8000AA-3, US 93/42 Wireless Handheld Multi-Parameter System (H500) MODEL CO-PILOT 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000AA-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000J-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SL-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SM-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SS-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000AA-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000J-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000SL-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000SM-WO2 93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE 93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE, PACK, NOX 93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE, PHILIPS 93/42 Wrist-Worn Pulse Oximeter MODEL 3150SC, WRIST-OX2 USB COMM CABLE, PHILIPS 93/42 Wrist-Worn Pulse Oximeter MODEL 3150USB, 8000SS-WO2 93/42 WristOx2® Model 3150 MODEL 3150WB, PKG ASSY, 3150WB, WRISTBAND 93/42 WristOx2® Model 3150 with Bluetooth® Low Energy Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE 93/42
IIb
93/42
regulatory@nonin.com
EUDAMED record
Report an error
Fazzini
Italy
145 others
I, IIa
MDR, 93/42
Website
INFO@FAZZINI.IT
EUDAMED record
Report an error
groupe lépine
France
144 others
IIa
93/42
Website
EUDAMED record
Report an error
Olympus Winter & Ibe FDA
Germany
143 others Electrosurgical generator ESG-150 93/42 Electrosurgical generator ESG-300 Electrosurgical Generators - ESG-300 3 refs Electrosurgical generator ESG-400 Electrosurgical Generators - ESG-400 2 refs Electrosurgical generator ESG-410 Electrosurgical Generators - ESG-410 2 refs Electrosurgical generator, B-Type CELON ELITE ESG-200 2 refs Electrosurgical generator, B-Type CELON Precision 2 refs Foot switch 3 refs Guiding tube, for probes 93/42 Guiding tube, for probes, with retractor 93/42 Inner sheath, for 26 Fr. outer sheath 93/42 Inner sheath, for 26 Fr. outer sheath, with A22085A 93/42 Inner sheath, long, for WA22018A and WA22019A 93/42 Inner sheath, long, for WA22018A/19A, with deflecting tip obturator 93/42 Irrigation port, 1 Luer-Lock connector, rotatable 93/42 Irrigation port, 1 stopcock, rotatable 93/42 Irrigation port, 1 vertical stopcock, fixed 93/42 Irrigation port, 2 stopcocks, rotatable 93/42 LG-adapter, 90°, OES telescope to OES LG cable 3 refs Light guide, 3 mm, 2,5 m, fluid, plug type, PDD Light source , for flexible endoscopes EndoLED 2 refs Light source , for stroboscopy OLYMPUS CLL-S1 2 refs Obturator 17 Fr. 3 refs Obturator optical, 19.8 Fr. 93/42 Obturator optical, 21 Fr. 93/42 Obturator optical, 22.5 Fr. 93/42 Obturator optical, 25 Fr. 93/42 Obturator, 15.5 Fr., for A20930A 93/42 Obturator, 17 Fr., for A20911A 93/42 Obturator, 19.8 Ch., for A20916A 93/42 Obturator, 19.8 Fr, for A20912A 93/42 Obturator, 21 Fr., for A20913A 93/42 Obturator, 21 Fr., for A20933A 93/42 Obturator, 22.5 Fr., for A20914A/-34A 93/42 Obturator, 24 Fr. 93/42 Obturator, 25 Fr. 93/42 Obturator, 26 Fr. 93/42 Obturator, 5 mm 93/42 Obturator, deflecting tip, 24 Fr. 93/42 Obturator, deflecting tip, 26 Fr. 93/42 Obturator, for A3551, 4 Fr. channel 93/42 Obturator, optical, 24 Fr. 93/42 Obturator, optical, 24 Fr., long 93/42 Obturator, optical, 26 Fr. 93/42 Obturator, optical, for A42021A 93/42 OP telescope, 0°, 5 mm channel 93/42 OP telescope, 7°, 11 Fr. x 220 mm, 7.5 Fr. channel, angled ocular 93/42 OP-telescope, 30°, 4 mm channel 93/42 Outer sheath, 26 Fr., 2 stopcocks, rotatable 93/42 Outer sheath, 26 Fr., 2 stopcocks, vertical, fixed 93/42 Outer sheath, 26 Fr., for A3551 93/42 Outer sheath, 27 Fr, 2 stopcocks, vertical, fixed 93/42 Outer sheath, 27 Fr., 2 stopcocks, rotatable 93/42 Outer sheath, 27 Fr., long, rotatable 93/42 Outer sheath, 27 Fr., long, rotatable, for tumor resection 93/42 Outer sheath, 28 Fr., 2 stopcocks, rotatable 93/42 Outer sheath, 8.5 mm / 26 Fr., 2 stopcocks, rotatable 93/42 Pressure reducer, with connector acc. to BS 341 No. 3, for Argon Plasma Coagulation 93/42 Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation 93/42 Pressure reducer, with connector acc. to DIN 477 No. 10, for Argon Plasma Coagulation 93/42 Pressure reducer, with connector acc. to DIN 477 No.6, for Argon Plasma Coagulation 93/42 Pressure reducer, with connector acc. to ISO 5145 No. 4, for Argon Plasma Coagulation 93/42 Pressure reducer, with connector acc. to JIS B8246, for Argon Plasma Coagulation 93/42 Resection sheath, 24 Fr. 93/42 Resection sheath, 24 Fr., with deflecting obturator 93/42 Resection sheath, 26 Fr. 93/42 Resection sheath, 26 Fr., with deflecting obturator 93/42 Resection sheath, 8 mm, for 8.5 mm outer sheath 93/42 Sheath, 22 Fr., for urethrotome 93/42 Sheath, 3.0 mm 93/42 Sheath, 4 mm 93/42 Sheath, 4.5 mm, 5 Fr. channel, continuous irrigation 93/42 Sheath, 4.5 mm, continuous irrigation, 3 Fr. channel 93/42 Sheath, 5 mm 93/42 Sheath, 5.5 mm, 5 Fr. channel, continuous irrigation 93/42 Sheath, 5.5 mm, continuous irrigation, 3 Fr. channel 93/42 Sheath, 6.5 mm, continuous flow, 5 Fr. channel 93/42 Sheath, 6.5 mm, continuous irrigation, 7 Fr. channel 93/42 Telescope IR, 5.4 mm, 30° ULTRA 93/42 Telescope , 2.7 mm, 30°, autoclavable TrueView II 93/42 Telescope 10 mm, 0° ULTRA 93/42 Telescope 10 mm, 30° ULTRA 93/42 Telescope 10 mm, 45° ULTRA 93/42 Telescope 5.4 mm, 0° ULTRA 93/42 Telescope 5.4 mm, 30° ULTRA 93/42 Telescope 5.4 mm, 45° ULTRA 93/42 Telescope IR, 10 mm, 30°, short ULTRA 93/42 Telescope IR, 5.4 mm, 0° ULTRA 93/42 Telescope, 10 mm, 0° IR 93/42 Telescope, 10 mm, 30° IR 93/42 Telescope, 10 mm, 70°, autoclavable 93/42 Telescope, 10 mm, 90°, autoclavable 93/42 Telescope, 2.7 mm, 0°, autoclavable TrueView II 93/42 Telescope, 2.7 mm, 70°, autoclavable TrueView II 93/42 Telescope, 2.7mm, 30°, short, autoclavable TrueView II 93/42 Telescope, 3 mm, 0°, autoclavable 93/42 Telescope, 3 mm, 12°, autoclavable 93/42 Telescope, 3 mm, 30°, wideangle, autoclavable 93/42 Telescope, 4 mm, 0° ULTRA 93/42 Telescope, 4 mm, 0°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 0°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 0°, with trocar tube connector ULTRA 93/42 Telescope, 4 mm, 12 °, PDD, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 12°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 12°, long 93/42 Telescope, 4 mm, 30 °, PDD, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 30 °, wide-angle, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 30° inverse ULTRA 93/42 Telescope, 4 mm, 30° ULTRA 93/42 Telescope, 4 mm, 30°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 30°, connector for light guide on top, autoclavable 93/42 Telescope, 4 mm, 30°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 30°, with trocar tube connector ULTRA 93/42 Telescope, 4 mm, 45° inverse ULTRA 93/42 Telescope, 4 mm, 45° ULTRA 93/42 Telescope, 4 mm, 45°, connector for light guide on top, autoclavable 93/42 Telescope, 4 mm, 45°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 70 °, PDD, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 70° inverse ULTRA 93/42 Telescope, 4 mm, 70° ULTRA 93/42 Telescope, 4 mm, 70°, connector for light guide on bottom, autoclavable 93/42 Telescope, 4 mm, 70°, connector for light guide on top, autoclavable 93/42 Telescope, 4 mm, 70°, HD, autoclavable OES ELITE 93/42 Telescope, 4 mm, 70°, long 93/42 Telescope, 4 mm, 70°, with trocar tube connector ULTRA 93/42 Versapoint II Electrosurgical Generator non-sterile, reusable 93/42 Versapoint II Footswitch non-sterile, reusable 93/42 Video telescope , 10 mm, 0° ENDOEYE 3D 93/42 Video telescope , 10 mm, 30° ENDOEYE 3D 93/42 Video telescope , 10 mm, 30°, autoclavable ENDOEYE HD II 93/42 Video telescope , 5.4 mm, 0°, autoclavable ENDOEYE HD II 93/42 Video telescope, 5.4 mm, 30°, autoclavable ENDOEYE HD II 93/42 Video telescope, 10 mm, 0°, autoclavable ENDOEYE HD II 93/42 Washer-disinfector PAA ETD Double 93/42 Working element, active 93/42 Working element, active, for resection in saline 93/42 Working element, for A3551 93/42 Working element, for probes 93/42 Working element, passive 93/42 Working element, passive, for resection in saline 93/42 Working insert, 24 Fr., 6 Fr. channel 93/42 Working insert, 8.5 mm, 8 Fr. channel, for A42021A 93/42 Telescope, 1.9 mm, 0°, 280mm, autoclavable 93/42 (no longer marketed) Telescope, 1.9 mm, 30°, 280 mm, autoclavable 93/42 (no longer marketed)
I, IIa, IIb
MDR, 93/42
Website
eudamed.regulatoryaffairs@olympus-oste.eu
EUDAMED record
Report an error
BNOS MediTECH
EU representative : Medical Device Management Ltd (Ireland)
United Kingdom (ex Northern Ireland)
126 others microVENT Advanced European Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT Advanced European Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Advanced European Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Advanced European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Advanced European Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator -DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator, AFNOR French fitting, White Hose. 93/42 microVENT Classic, Standard - AGA fitting, white hose 93/42 microVENT Classic, Standard - DIN (Hayer) fitting, white hose 93/42 microVENT Classic, Standard - JIS fitting, green hose 93/42 microVENT Classic, Standard Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT Classic, Standard Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT Classic, Standard Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT Classic, Standard Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Classic, Standard Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Classic, Standard Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Classic, Standard Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT Classic, Standard, - BS fitting (Schrader probe), white hose 93/42 microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - AFNOR French fitting, white hose 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - AGA fitting, white hose 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - BS fitting (Schrader probe), white hose 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - DIN (Hayer) fitting, white hose 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - JIS fitting, green hose 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - SIS Australian fitting, white hose 93/42 microVENT CPR Resuscitator, Standard, Adult and Child - UNIFOR (Italian) Fitting, White Hose 93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - AFNOR French fitting, white hose 93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - AGA fitting, white hose 93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief 2 refs 93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - JIS fitting, green hose 93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator -SIS Australian fitting, white hose 93/42 Microvent Industrial, Advanced, Adult Only, BS Probe 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - AFNOR French fitting, white hose 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - AGA fitting, white hose 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - JIS fitting, green hose 93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - SIS Australian fitting, white hose 93/42 Microvent Lithuania Spec, A/C Adv, AGA Hose, Stretcher Bracket 93/42 microVENT Responder Resuscitator, Adult and Child - AFNOR French fitting, white hose 93/42 microVENT Responder Resuscitator, Adult and Child - AGA fitting, white hose 93/42 microVENT Responder Resuscitator, Adult and Child - BS fitting (Schrader probe), white hose 93/42 microVENT Responder Resuscitator, Adult and Child - DIN (Hayer) fitting, white hose 93/42 microVENT Responder Resuscitator, Adult and Child - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Responder Resuscitator, Adult and Child - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Responder Resuscitator, Adult and Child - JIS fitting, green hose 93/42 microVENT Responder Resuscitator, Adult and Child - SIS Australian fitting, white hose 93/42 microVENT Standard European Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT Standard European Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT Standard European Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT Standard European Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT Standard European Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT Standard European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT Standard European Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - JIS fitting, green hose 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - AFNOR French fitting, white hose 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - AGA fitting, white hose 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - SIS Australian fitting, white hose 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - AFNOR French fitting, white hose 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - AGA fitting, white hose 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - JIS fitting, green hose 93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - SIS Australian fitting, white hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT World, Advanced, Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - SIS Australian fitting, white hose 93/42 microVENT World, Advanced, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White Hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - SIS Australian fitting, white hose 93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White hose 93/42 Microvent World, Airmix, Advanced 3M Hose AGA Probe 93/42 microVENT World, Standard, Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT World, Standard, Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT World, Standard, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT World, Standard, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT World, Standard, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT World, Standard, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT World, Standard, Adult and Child Resuscitator - SIS Australian fitting, white hose 93/42 microVENT World, Standard, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White Hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - AGA fitting, white hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - JIS fitting, green hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - SIS Australian fitting, white hose 93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White Hose 93/42 Mircovent microVENT World, Standard, Adult and Child Resuscitator - JIS fitting, green hose 93/42
IIa
93/42
Website
sales@meditech.uk.com
EUDAMED record
Report an error
Lamidey Noury Medical FDA
France
114 others Angled bipolar forceps 16cm blunt tip 8x1mm 93/42 Angled bipolar forceps 18cm blunt tip 6x0.5mm 93/42 Angled bipolar forceps 18cm blunt tip 8x1mm 93/42 Angled bipolar forceps 18cm blunt tip 8x2mm 93/42 Angled bipolar forceps 20cm smooth tip 8x1mm 93/42 Angled bipolar forceps 20cm smooth tip 8x2mm 93/42 Angled bipolar forceps 22cm tip 8x1mm 93/42 Angled bipolar forceps 22cm tip 8x2mm 93/42 AS64R high flow suction units 93/42 Bayonet bipolar forceps 16cm blunt tip 6x0.5mm 93/42 Bayonet bipolar forceps 16cm blunt tip 8x1mm 93/42 Bayonet bipolar forceps 20cm smooth tip 8x1mm 93/42 Bayonet bipolar forceps 20cm smooth tip 8x2mm 93/42 Bayonet bipolar forceps 20cm tip 6x0.3mm 93/42 Bayonet bipolar forceps 22cm tip 6x0.3mm 93/42 Bayonet bipolar forceps 22cm tip 8x1mm 93/42 Bayonet bipolar forceps 22cmtip 6x0.5mm 93/42 Bayonet bipolar forceps 25cm tip 6x0.5mm 93/42 Bayonet bipolar forceps 25cm tip 8x1mm 93/42 Curved bayonet bipolar forceps (Black curved) 20cm blunt tip 8x1mm 93/42 Curved bayonet bipolar forceps (Forward curved) 20cm blunt tip 8x1mm 93/42 Curved THERMOCLAMP 160mm Thin jaws 93/42 Curved THERMOCLAMP 16cm with automatic recognition cable 93/42 Curved THERMOCLAMP 220mm curved jaws 93/42 Curved Thermoclamp 22cm with automatic recognition cable 93/42 Cutting forceps THERMOCUT for vessel sealing, 10mm diameter, Jaws 10mm, Lg.20cm 93/42 Cutting forceps THERMOCUT for vessel sealing, 10mm diameter, Jaws 10mm, Lg.33cm 93/42 Cutting forceps THERMOCUT for vessel sealing, 5mm diameter, Jaws 5m, Lg.33cm 93/42 Cutting forceps THERMOCUT for vessel sealing, 5mm diameter, Jaws 5mm, Lg.20cm 93/42 DERLEC electrosurgical pencils for electrode Ø2.4mm 93/42 DERLEC electrosurgical pencils for electrode Ø4mm 93/42 Electrodes angled ball insulated, ball Ø 3mm Lg 65mm 93/42 Electrodes angled blade insulated overmoulding, Lg 115mm 93/42 Electrodes angled blade insulated overmoulding, Lg 60mm 93/42 Electrodes angled blade insulated overmoulding, Lg 80mm 93/42 Electrodes angled blade insulated, Lg 115mm 93/42 Electrodes angled blade insulated, Lg 60mm 93/42 Electrodes angled blade insulated, Lg 80mm 93/42 Electrodes straight ball insulated overmoulding, ball Ø 4mm Lg 132mm 93/42 Electrodes straight ball insulated overmoulding, ball Ø 4mm Lg 57mm 93/42 Electrodes straight ball insulated, ball Ø 3mm Lg 117mm 93/42 Electrodes straight ball insulated, ball Ø 3mm Lg 62mm 93/42 Electrodes straight ball insulated, ball Ø 3mm Lg 81mm 93/42 Electrodes straight ball insulated, ball Ø 4mm Lg 117mm 93/42 Electrodes straight ball insulated, ball Ø 4mm Lg 62mm 93/42 Electrodes straight ball insulated, ball Ø 4mm Lg 81mm 93/42 Electrodes straight ball insulated, ball Ø 5mm Lg 117mm 93/42 Electrodes straight ball insulated, ball Ø 5mm Lg 62mm 93/42 Electrodes straight ball insulated, ball Ø 5mm Lg 81mm 93/42 Electrodes straight blade insulated overmoulding, blade 20mm Lg 115mm 93/42 Electrodes straight blade insulated overmoulding, blade 20mm Lg 65mm 93/42 Electrodes straight blade insulated overmoulding, blade 20mm Lg 84mm 93/42 Electrodes straight blade insulated, blade 20mm Lg 120mm 93/42 Electrodes straight blade insulated, blade 20mm Lg 65mm 93/42 Electrodes straight blade insulated, blade 20mm Lg 84mm 93/42 Electrodes straight blade insulated, curved blade 5mm Lg 84mm 93/42 Electrodes straight blade uninsulated, blade 20mm Lg 50mm 93/42 Electrodes straight loop insulated, loop Ø 6mm Lg 120mm 93/42 Electrodes straight loop insulated, loop Ø 6mm Lg 60mm 93/42 Electrodes straight loop insulated, loop Ø 6mm Lg 84mm 93/42 Electrodes straight loop insulated, loop Ø 8mm Lg 120mm 93/42 Electrodes straight loop insulated, loop Ø 8mm Lg 60mm 93/42 Electrodes straight loop insulated, loop Ø 8mm Lg 84mm 93/42 Electrodes straight needle insulated overmoulding, pointe Ø0.8mm Lg 60mm 93/42 Electrodes straight needle insulated, pointe Ø0.5mm Lg 120mm 93/42 Electrodes straight needle insulated, pointe Ø0.5mm Lg 65mm 93/42 Electrodes straight needle insulated, pointe Ø0.5mm Lg 84mm 93/42 Générateur électrochirurgical bipolaire MCB V10GMCB 93/42 Générateurs électrochirurgicaux monopolaires/bipolaires (400W max) V10GMS 93/42 Générateurs électrochirurgicaux OPTIMA V10GOPT4 93/42 Handle Cutting forceps THERMOCUT for vessel sealing, 10mm diameter 93/42 Handle Cutting forceps THERMOCUT for vessel sealing, 5mm diameter 93/42 Insert of THERMOCUT forceps, 10mm diameter, Jaws 10mm, Lg.33cm 93/42 Insert of THERMOCUT forceps, 10mmdiameter, Jaws 10mm, Lg.33cm 93/42 Insert of THERMOCUT forceps, 5mm diameter, Jaws 5mm, Lg.20cm 93/42 Insert of THERMOCUT forceps, 5mm diameter, Jaws 5mm, Lg.33cm 93/42 MODULE DE DISTRIBTION D’ARGON V11A100 93/42 Push-blade for THERMOCUT forceps, 10mm, Lg.20cm 93/42 Push-blade tube for THERMOCUT forceps, 10mm diameter, Lg.33cm 93/42 Reussable bipolar cutting loop UNIV / THICK (round ; Fr26) VXPR2 93/42 Rosace tube for THERMOCUT forceps, 10mm diameter, Lg.20cm 93/42 Rosace tube for THERMOCUT forceps, 10mm diameter, Lg.33cm 93/42 Rosace tube for THERMOCUT forceps, 5mm diameter, Lg.20cm 93/42 Rosace tube for THERMOCUT forceps, 5mm diameter, Lg.33cm 93/42 Set of 8 standards electrodes 93/42 Sterile blades, single use, for THERMOCUT forceps, Lg.266mm 93/42 Sterile blades, single use, for THERMOCUT forceps, Lg.451mm 93/42 Straight Adson bipolar forceps 11cm blunt tip 5x0.3mm 93/42 Straight Adson bipolar forceps 11cm EU plug smooth tip 5x0.5mm 93/42 Straight Adson bipolar forceps 11cm smooth tip 5x1mm 93/42 Straight bipolar droite 20cm smooth tip 6x0.3mm 93/42 Straight bipolar droite 20cm smooth tip 8x1mm 93/42 Straight bipolar droite 22cm smooth tip 8x1mm 93/42 Straight bipolar droite 22cm smooth tip 8x2mm 93/42 Straight bipolar droite 25cm smooth tip 8x2mm VPB25D20 93/42 Straight bipolar forceps 13cm blunt tip 6x0.3mm 93/42 Straight bipolar forceps 13cm blunt tip 6x0.5mm 93/42 Straight bipolar forceps 13cm blunt tip 6x1mm 93/42 Straight bipolar forceps 16cm blunt tip 6x0.3mm 93/42 Straight bipolar forceps 16cm smooth tip 8x1mm 93/42 Straight bipolar forceps 18cm blunt tip 6x0.3mm 93/42 Straight bipolar forceps 18cm blunt tip 8x2cm 93/42 Straight bipolar forceps 18cm blunt tip 8x2mm 93/42 Straight bipolar forceps 18cm smooth tip 8x1mm 93/42 Straight bipolar forceps 20cm smooth tip 8x2mm 93/42 Straight bipolar forceps 25cm smooth tip 8x1mm 93/42 TACTILEC electrosurgical pencils for electrode ø 4mm; pins plug 93/42 TACTILEC electrosurgical pencils for electrode - ø2.4mm ; 3 pins plug 93/42 TACTILEC electrosurgical pencils for electrode Ø 4mm ; ERBE ESU 93/42 TACTILEC electrosurgical pencils for electrodes ø 2,4mm;ERBE ESU 93/42 THERMOCISION forceps 16cm 93/42 THERMOCISION forceps 16cm with automatic recognition cable 93/42 THERMOCISION forceps 22cm with automatic recognition cable 93/42 THERMOCISION forceps LG 22cm 93/42
IIa, IIb
93/42
Website
prrc@lamidey-noury.fr
EUDAMED record
Report an error
Ningbo David Medical Device FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
114 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Eryigit
Türkiye
112 others
I, IIb
MDR, 93/42
Website
info@eryigit.com.tr
EUDAMED record
Report an error
Sykers
EU representative : Kingsmead Service B.V. (Netherlands)
China
109 others
I
MDR
contact@sykers.com
EUDAMED record
Report an error
Taijieweiye
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
109 others
III
93/42
EUDAMED record
Report an error
Uamedsurgical
EU representative : Yellow's medical instruments GmbH (Germany)
Pakistan
108 others
I
MDR
Website
info@uamedsurgical.com
EUDAMED record
Report an error
SMS
Poland
106 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Ertan Demirkollu - Cryomed Biomedikal Cihazlar İmalat İthalat ve İhracat Sanayi ve Ticaret
Türkiye
98 others BİMED 0612 dermatoloji probu 93/42 BİMED 0812 dermatoloji prob ucu 93/42 BİMED 1000 dermatoloji prob ucu 93/42 BİMED 1200 dermatoloji prob ucu 93/42 BİMED 1905 jinekoloji prob ucu 2 refs 93/42 BİMED 1905 jinekolojik prob ucu 93/42 BİMED 1910 jinekoloji prob ucu 3 refs 93/42 BİMED 1920 jinekoloji prob ucu 3 refs 93/42 BİMED 2507 jinekoloji prob ucu 2 refs 93/42 BİMED 2507 jinekolojik prob ucu 93/42 BİMED cryo chamber (odacığı) 10mm 93/42 BİMED cryo chamber (odacığı) 15mm 93/42 BİMED cryo chamber (odacığı) 18mm 93/42 BİMED cryo chamber (odacığı) 25mm 93/42 BİMED cryo chamber (odacığı) 30mm 93/42 BİMED cryo chamber (odacığı) 6mm 93/42 BİMED cryo kone seti 6'lı 93/42 BİMED cryo tabagı 1.5mm 93/42 BİMED cryo tabagı 10mm 93/42 BİMED cryo tabagı 12mm 93/42 BİMED cryo tabagı 15mm 93/42 BİMED cryo tabagı 18mm 93/42 BİMED cryo tabagı 3mm 93/42 BİMED cryo tabagı 4 'lu set 93/42 BİMED cryo tabagı 5mm 93/42 BİMED cryo tabagı 8 'li set 93/42 BİMED cryo tabagı 8mm 93/42 BİMED kontak (ball tip) prob 10mm 93/42 BİMED kontak (ball tip) prob 4mm 93/42 BİMED kontak (ball tip) prob 6mm 93/42 BİMED kontak (ball tip) prob 8mm 93/42 BİMED kontak (cervical tip) prob 1905 93/42 BİMED kontak (cervical tip) prob 1920 93/42 BİMED kontak (cervical tip) prob 2507 93/42 BİMED kontak (condyloma tip) prob 0519 93/42 BİMED kontak (flat tip) prob 10mm 93/42 BİMED kontak (flat tip) prob 15mm 93/42 BİMED kontak (flat tip) prob 20mm 93/42 BİMED kontak (flat tip) prob 25mm 93/42 BİMED kontak (flat tip) prob 30mm 93/42 BİMED kontak (konik tip) prob 10mm 93/42 BİMED kontak (konik tip) prob 1mm 93/42 BİMED kontak (konik tip) prob 2mm 93/42 BİMED kontak (konik tip) prob 3mm 93/42 BİMED kontak (konik tip) prob 4mm 93/42 BİMED kontak (konik tip) prob 5mm 93/42 BİMED kontak (konik tip) prob 6mm 93/42 BİMED kontak (konik tip) prob 7mm 93/42 BİMED kontak (konik tip) prob 8mm 93/42 BİMED kontak (konik tip) prob 9mm 93/42 BİMED kontak (mini tip) prob 10mm 93/42 BİMED kontak (mini tip) prob 1mm 93/42 BİMED kontak (mini tip) prob 2mm 93/42 BİMED kontak (mini tip) prob 3mm 93/42 BİMED kontak (mini tip) prob 4mm 93/42 BİMED kontak (mini tip) prob 5mm 93/42 BİMED kontak (mini tip) prob 6mm 93/42 BİMED kontak (mini tip) prob 7mm 93/42 BİMED kontak (mini tip) prob 8mm 93/42 BİMED kontak (mini tip) prob 9mm 93/42 BİMED MC 150 CRYO CİHAZI 93/42 BİMED MC-120 Cryo Cihazı 93/42 BİMED MC-120A Cryo Cihazı 93/42 BİMED MC-150 CRYOSET 93/42 BİMED oftalmoloji cryo probu (curved cataract) 1,5mm 93/42 BİMED oftalmoloji cryo probu (curved cataract) 1,6mm 93/42 BİMED oftalmoloji cryo probu (extended retina) 2,5mm 93/42 BİMED oftalmoloji cryo probu (glaucoma) 3,0mm 93/42 BİMED oftalmoloji cryo probu (glaucoma) 3,5mm 93/42 BİMED oftalmoloji cryo probu (intra-vitreal) 0,9mm 93/42 BİMED oftalmoloji cryo probu (mid-reach retina) 2,5mm 93/42 BİMED oftalmoloji cryo probu (special retina) 2,5mm 93/42 BİMED oftalmoloji cryo probu (standart retina) 2,5mm 93/42 BİMED oftalmoloji cryo probu (straight cataract) 1,6mm 93/42 BİMED sprey uc 0,4 mm 93/42 BİMED sprey uc 0,5 mm 93/42 BİMED sprey uç 0.6mm 93/42 BİMED sprey uç 0.7mm 93/42 BİMED sprey uç 0.8mm 93/42 BİMED sprey uç 0.9mm 93/42 BİMED sprey uç 1.0mm 93/42 BİMED standart sprey uç seti 5 'li 93/42 BİMED sıvı azot aktarma unitesi 10lt. 93/42 BİMED sıvı azot aktarma unitesi 20lt. 93/42 BİMED sıvı azot aktarma unitesi 26lt. 93/42 BİMED sıvı azot aktarma unitesi 30lt. 93/42 BİMED sıvı azot aktarma unitesi 35lt. 93/42 BİMED sıvı azot aktarma unitesi 50lt. 93/42 BİMED uzatma adaptörü 45 derece 93/42 BİMED uzatma adaptörü 90 derece 93/42 BİMED uzun düz sprey uc 14G 93/42 BİMED uzun düz sprey uc 16G 93/42 BİMED uzun düz sprey uc 18G 93/42 BİMED uzun düz sprey uc 20G 93/42 BİMED uzun egik sprey uc 14G 93/42 BİMED uzun egik sprey uc 16G 93/42 BİMED uzun egik sprey uc 18G 93/42 BİMED uzun egik sprey uc 20G 93/42
IIa
93/42
Website
EUDAMED record
Report an error
Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
97 others Anesthesia Machine A80C 93/42 Anesthesia Machine A8C 93/42 Anesthesia Machine A9 Pro 93/42 Anesthesia Machine A90 93/42 Anesthesia Machine A90C 93/42 Anesthesia Machine A9C 93/42 Anesthesia Machine WATO EX-20 93/42 Anesthesia Machine WATO EX-25 93/42 Anesthesia Machine WATO EX-30 93/42 Anesthesia Machine WATO EX-35 93/42 Anesthesia System A5 93/42 Anesthesia System A7 93/42 Anesthesia System A8 93/42 Anesthesia System WATO EX-55 93/42 Anesthesia System WATO EX-55 Pro 93/42 Anesthesia System WATO EX-55C 93/42 Anesthesia System WATO EX-55C Pro 93/42 Anesthesia System WATO EX-65C 93/42 Anesthesia System WATO EX-65C Pro 93/42 Anesthesia System WATO EX-75 93/42 Anesthesia System WATO EX-75C 93/42 Anesthesia System WATO EX-85 93/42 Anesthesia System WATO EX-85C 93/42 Anesthetic Vaporizer V60 93/42 Anesthetic Vaporizer V80 93/42 Automated External Defibrillator BeneHeart C1A 93/42 Automated External Defibrillator BeneHeart C2 93/42 Automated External Defibrillator BeneHeart D1 93/42 BeneVision N1 Camera Head CHX-LW010 3 refs Central Monitoring System 60-14100-00/GA3202/GA3212/GA3211/040-001187-00/GA3201/60-14200-00 2 refs CO Module kit(B03B V2.0) BeneVision N17 3 refs Defibrillator/Monitor uMED 20/uMED 20A 2 refs 93/42 eGateway Integration Manager Electrocardiograph BeneHeart R12 93/42 Electrocardiograph BeneHeart R12/BeneHeart R12B/BeneHeart R12A/BeneHeart R3/BeneHeart R3B/BeneHeart R3A 3 refs Electrocardiograph BeneHeart R900\BeneHeart R90\BeneHeart R700\BeneHeart R70\BeneHeart R300\BeneHeart R30 3 refs enteral feeding pump BeneFusion cNP/BeneFusion cDNP 2 refs ePM 12 93/42 EV100 3 refs EV100, EV100B, EV100C, EV100 Platinum 2 refs FX1, FX10, FX11, FX12 3 refs HB130, HB310, HB320, HB330, HB100, HB100-TEC, HB300, HB300-TEC 3 refs HB300L 3 refs HB300R 3 refs HB500 3 refs HB500R 2 refs HD3 3 refs HS-50F 3 refs HyBase 3 refs HyLED XE91 3 refs HyLED(Video) Infusion Pump BeneFusion eVP/BeneFusion nVP ex/BeneFusion eVP ex/BeneFusion nVP Neo/BeneFusion eVP Neo/BeneFusion nVP 3 refs Infusion Pump BeneFusion uVP/BeneFusion iVP/BeneFusion iVP ex/BeneFusion uVP ex 3 refs Infusion Supervision System BeneFusion eDS ex/BeneFusion eDS/BeneFusion nDS ex/BeneFusion nDS 3 refs Infusion Supervision System BeneFusion nCS LC0005S 3 refs MRI Infusion Workstation BeneFusion MRI Station NIBP Cuff CM1103 3 refs Patient Monitor BeneVision MRI Patient monitor BeneVision N22/BeneVision N22 OR/BeneVision N22 ICU/BeneVision N19/BeneVision N19 OR/BeneVision N19 ICU/ BeneVision M22/BeneVision M22C/BeneVision M19/BeneVision M19C 3 refs Patient monitor BeneVision VMAX 3 refs Patient Monitor cPM 15M 3 refs Patient Monitor uMEC 30 2 refs Patient Monitor uMEC6, uMEC15S, uMEC15, uMEC10, uMEC7, uMEC12 6 refs 93/42 Pulse Oximeter PM-60 93/42 R1 3 refs Rigid Endoscope M 00430A, G 00430A, M 00412A, G 00412A, M 02930A, G 02930A, M 02912A, G 02912A, M 00430PA, G 00430PA, M 00412PA, G 00412PA, M 02930PA, G 02930PA, M 02912PA, G 02912PA 3 refs Rigid Endoscope M 00430A/ M 02930A/ G 00430A/ G 02930A, G S041601H / G S291401H, G S042000H / G S291600H, G C042000H / G C291600H 3 refs Rigid Endoscope M 02900A, M 02930A, G 02900A, G 02930A, M 02900PA, M 02930PA, G 02900PA, G 02930PA, M 00400A, M 00430A, M 00470A, G 00400A, G 00430A, G 00470A, M 00400PA, M 00430PA, M 00470PA, G 00400PA, G 00430PA, G 00470PA 3 refs Single-Use Cysto-Nephroscope FCY08-L069BAF, FCY07-L070BAF, FCY08-L069PAF, FCY07-L070PAF, FCY14-M040MBF, FCY16-M040MBF, FCY14-M041PBF, FCY16-M041PBF, FCY14-M040PBR, FCY16-M040PBR 3 refs Single-Use Ureteroscope FUR08-L068BBF, FUR08-L069BBF, FUR08-L070BBF, FUR08-L070BBR, FUR08-L068NBF, FUR08-L069NBF, FUR08-L070MBF, FUR08-L070MBR, FUR08-L068PBF, FUR08-L069PBF, FUR08-L070PBF, FUR08-L070PBR 3 refs SurgiCore, MR-DOR Syringe Pump BeneFusion eSP Neo/BeneFusion nSP/BeneFusion eSP ex/BeneFusion eSP/BeneFusion nSP ex/BeneFusion nSP Neo 3 refs Syringe Pump BeneFusion uSP/BeneFusion iSP/BeneFusion uDSP ex/BeneFusion uSP ex/BeneFusion iSP ex/BeneFusion uDSP 3 refs Telemetry Monitor TM80 U1 3 refs UX1 3 refs UX7 3 refs V60 93/42 Ventilator NB300 93/42 Ventilator NB350 93/42 Ventilator NB380 93/42 Ventilator SV300 93/42 Ventilator SV300 Pro 93/42 Ventilator SV350 93/42 Ventilator SV350 Pro 93/42 Ventilator SV600 93/42 Ventilator SV650 93/42 Ventilator SV800 93/42 Ventilator SV850 93/42 Ventilator SynoVent E3 93/42 Ventilator SynoVent E5 93/42 Vital Signs Monitor VS-600 VS 9C WATO EX-65 93/42 Wearable Patient Monitor EP30
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Tianjin Bolang Science-Technology Development
EU representative : Lotus NL B.V. (Netherlands)
China
96 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Lumitex FDA
EU representative : MDSS GmbH (Germany)
United States
BiliSoft 2.0 PT Systems, Large Pad, Arabic, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Arabic, UK Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Arabic, US Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Brazilian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Bulgarian, CE Plug 93/42 95 others BiliSoft 2.0 PT Systems, Large Pad, Chinese, CCC Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Croatian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Czech, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Danish, Danish Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Dutch, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Dutch, US Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, Australian Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, Indian Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, South Africa Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, UK Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, UK Plug, Malaysian 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, US Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, English, US Plug, Homecare 93/42 BiliSoft 2.0 PT Systems, Large Pad, Estonian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Finnish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, French, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, French, Swiss Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, French, US Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, German, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, German, Swiss Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Greek, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Hungarian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Indonesian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Italian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Italian, Swiss Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Japanese, JP Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Kazakh, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Korean, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Latvian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Lithuanian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Norwegian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Polish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Portuguese, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Romanian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Russian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Serbian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Slovakian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Spanish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Spanish, Italy Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Spanish, US Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Swedish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Turkish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Ukrainian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Large Pad, Vietnamese, US Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Arabic, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Arabic, UK Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Arabic, US Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Brazilian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Bulgarian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Chinese, CCC Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Croatian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Czech, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Danish, Danish Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Dutch, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Dutch, US Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, Austraillian Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, Indian Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, South Africa Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, UK Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, UK Plug, Malaysian 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, US Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, English, US Plug, Homecare 93/42 BiliSoft 2.0 PT Systems, Small Pad, Estonian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Finnish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, French, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, French, Swiss Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, French, US Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, German, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, German, Swiss Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Greek, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Hungarian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Indonesian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Italian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Italian, Swiss Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Japanese, JP Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Kazakh, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Korean, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Latvian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Lithuanian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Norwegian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Polish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Portuguese, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Romanian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Russian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Serbian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Slovakian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Spanish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Spanish, Italy Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Spanish, US Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Swedish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Turkish, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Ukrainian, CE Plug 93/42 BiliSoft 2.0 PT Systems, Small Pad, Vietnamese, US Plug 93/42
IIa
93/42
Website
EUDAMED record
Report an error
Designs for Vision FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
93 others Adapter, USB Switchcraft 4912-0000-0011 Battery Pod Kit,Wireless-3 Pod 4906-0000-3001 Bracket Assy, Extension Arm & Infinity TS 4908-0023-0000 Bracket Assy, Orascoptic ROH Elite/Ergo Edge 4708-0026-0000 Bracket Assy, Universal 4908-0004-0000 Bracket Assy, Yeoman “T” Mount 4908-0010-0000 Bracket Assy, Zeiss 4708-0018-0000 Cable Assy, LED Micro Left 4911-0000-0022 Cable Assy, LED Nano 4’5” w/Ty-Wrap Right 4901-0001-1122 Charger&Cord,3C 4709-0000-3019 ClearView Laser Loupe Clip, Belt 4911-0002-0029 Common Platform, LED Daylight Dental Complete 4914-0000-0005 Cradle Assy, Wireless 4906-0000-0004 Expanded Field Loupe Foot Pedal Assy, Shield 4002-0001-0048 General Headlight GLS General Loupe Hdset LED TwinBeam DV 4709-2000-0001 Headband Assy DVT Mount 4709-3000-0005 Holster, Power Pack Universal 0030-4912-0001 Infinity Loupe Laser Sport/RX Loupe LED Classic DayLite Charger Universal 4912-0000-2019 LED DayLite 4.5 Cable Assy Right 4702-0001-0022 LED DayLite Battery Pod Assy 4906-0000-0001 LED DayLite Dental UltraMini HDi Complete 4902-3003-1002 LED DayLite Dental UltraMini HDi IR Basic 4932-3003-1012 LED DayLite Dental UltraMini HDi IR Complete 4932-3003-1002 LED DayLite HDi Optical Assy 4702-3000-0001 LED DayLite HDi Optical Assy 4702-3002-0001 LED DayLite HDi Ultramini HDi XQE/XRE Complete 4902-3002-0001 LED DayLite Micro Basic Common Platform 4911-0001-0005 LED DayLite Micro Cable Assy Right 4911-0001-0022 LED DayLite Micro Complete Common Platform 4911-0000-0005 LED DayLite Micro HDi Basic 4902-3002-1012 LED DayLite Micro HDI Basic Int'l 4902-3002-1112 LED DayLite Micro HDi Complete Int'l 4902-3002-1122 LED DayLite Micro HDi IR Basic 4932-3000-1012 LED DayLite Micro Standard Imaging Basic 4929-0000-0000 LED DayLite Micro Standard Imaging Complete 4929-0002-0000 LED DayLite NanoCam 4K Camera assembly only 4003-3004-0004 LED DayLite NanoCam GO Camera Complete 4003-3080-0004 LED DayLite NanoCam HD Camera Complete 4003-3000-0000 LED DayLite NanoCam HDi Headlight Complete 4003-3000-1002 LED DayLite Powerpack Assy 4914-0000-0001 LED DayLite REVEAL FC 9500-0000-0000 LED DayLite Surgical Charger + Cord 2C 4709-0000-2019 LED DayLite Surgical Complete Common Platform 4912-0000-0005 LED DayLite Surgical PowerPack Assy with Holster 4912-0001-0000 LED DayLite Surgical TwinBeam DV HDi Complete 4709-3000-1002 LED DayLite Surgical Ultra Mini HDi-Optical Assy 4902-3002-0021 LED DayLite Surgical Ultra Mini Headlight Assy 4902-0000-0002 LED DayLite Surgical UltraMini HDi Basic 4902-3000-1012 LED DayLite Surgical UltraMini HDi Complete 4902-3000-1002 LED DayLite Surgical UltraMini PS HDi Complete 4902-3001-1002 LED DayLite Surgical USB DayLite HDi Complete 4702-3000-1002 LED DayLite Ultra Mini CSV Standard Imaging Assy 4929-3002-0002 LED DayLite UltraMini CSV Standard Headlight Assy 4929-3000-0002 LED DayLite Ultramini Nano Dental Headlight Assy 4901-0000-0002 LED DayLite WireLess 4906-0000-0000 LED DayLite Wireless Battery 10440 350 mAh 4907-0000-1018 LED DayLite Wireless Battery 10440 350 mAh 4912-0000-0001 LED DayLite WireLess HDi IR 4916-3000-0000 LED DayLite Wireless HDi IR Optical Assy 4916-3001-0003 LED DayLite WireLess Mini 4907-0000-0000 LED DayLite Wireless Mini Cradle Assy 4907-0000-0004 LED DayLite WireLess Mini HDi 4907-0004-0000 LED DayLite Wireless Mini HDi Optical Assy 4907-0004-0002 LED DayLite Wireless Optical Assy 4906-0001-0003 LED NanoCam Go Surg UltraMini HDi Complete 4902-3180-1002 LED TriBeam DayLite Plus 4913-3002-0002 LED TriBram DayLite Yellow 4480-3000-1002 LED Wireless System Mini HDi 4907-0004-0000 Loupe/Light Combo CFG-LL-CB NanoCam 4K Complete with DayLite HDi 4702-3004-1002 NanoCam 4K Complete with Panoramic Spot PS Surgical HDi 4902-3004-1002 NanoCam 4K System without LED Headlight 4003-3004-0000 NanoCam Go Complete with Panoramic Spot PS Surgical HDi 4902-3080-1002 NanoCam Go System without LED Headlight 4003-3080-0000 Optical Assy, LED DayLite T-mount 4708-0008-0002 Optical Assy, Wireless Mini 4907-0001-0003 Panoramic Field Loupe Plug & Cord, Japan 4706-0000-0037 Plug & Cord, U .K (English Fused) 4706-0000-0034 Plug Cord European 4706-0000-0030 PowerPack DayLite Micro 4911-0000-0001 ReVeal FC Reveal FC Observation Systems Reveal Loupe Solea Laser Loupe Standard Field Loupe TwinBeam HDi CXL Complete 4709-3005-1002
I
MDR
Website
EUDAMED record
Report an error
Omron FDA
EU representative : OMRON Healthcare Europe B.V. (Netherlands)
Japan
94 others
I, IIa
MDR
info_omronhealthcare@omron.com
EUDAMED record
Report an error
Medigma Biomedical
Germany
90 others Drill S-5.5, 2.5/1.8mmDx16.0mmL 93/42 Drill S-5.5, 2.5/1.8mmDx18.0mmL 93/42 Drill S-5.5, 2.5/1.8mmDx8.0mmL 93/42 Drill S-5.5, 3.2/2.5mmDx10.0mmL 93/42 Drill S-5.5, 3.2/2.5mmDx13.0mmL 93/42 Drill S-5.5, 3.2/2.5mmDx16.0mmL 93/42 Drill S-5.5, 3.2/2.5mmDx18.0mmL 93/42 Drill S-5.5, 3.2/2.5mmDx6.25mmL 93/42 Drill S-5.5, 3.2/2.5mmDx8.0mmL 93/42 Drill S-5.5, 3.85/3.2mmDx10.0mmL 93/42 Drill S-5.5, 3.85/3.2mmDx11.5mmL 93/42 Drill S-5.5, 3.85/3.2mmDx16.0mmL 93/42 Drill S-5.5, 3.85/3.2mmDx6.25mmL 93/42 Drill S-5.5, 4.6/3.85mmDx11.5mmL 93/42 Drill S-5.5, 4.6/3.85mmDx13.0mmL 93/42 Drill S-5.5, 4.6/3.85mmDx16.0mmL 93/42 Drill S-5.5, 4.6/3.85mmDx6.25mmL 93/42 Drill S-5.5, 4.6/3.85mmDx8.0mmL 93/42 Drill Stopper for Long L10 1820 93/42 Drill Stopper for Long L10 1828 93/42 Drill Stopper for Long L10 1832 93/42 Drill Stopper for Long L10 1836 93/42 Drill Stopper for Long L10 1842 93/42 Drill Stopper for Long L10 1846 93/42 Drill Stopper for Long L10 1856 93/42 Drill Stopper for Long L11.5 1820 93/42 Drill Stopper for Long L11.5 1828 93/42 Drill Stopper for Long L11.5 1832 93/42 Drill Stopper for Long L13/Short L8 1828 93/42 Drill Stopper for Long L13/Short L8 1832 93/42 Drill Stopper for Long L13/Short L8 1836 93/42 Drill Stopper for Long L13/Short L8 1842 93/42 Drill Stopper for Long L13/Short L8 1846 93/42 Drill Stopper for Long L13/Short L8 1852 93/42 Drill Stopper for Long L15/Short L10 1828 93/42 Drill Stopper for Long L15/Short L10 1832 93/42 Drill Stopper for Long L15/Short L10 1836 93/42 Drill Stopper for Long L15/Short L10 1842 93/42 Drill Stopper for Long L15/Short L10 1846 93/42 Drill Stopper for Long L15/Short L10 1852 93/42 Drill Stopper for Long L15/Short L10 1856 93/42 Drill Stopper for Long L16 1832 93/42 Drill Stopper for Long L16 1836 93/42 Drill Stopper for Long L16 1852 93/42 Drill Stopper for Long L16 1856 93/42 Drill Stopper for Long L8 1820 93/42 Drill Stopper for Long L8 1852 93/42 Drill Stopper for LongL6 1832 93/42 Drill Stopper for LongL8 1832 93/42 Drill Stopper for Short L11.5 1320 93/42 Drill Stopper for Short L11.5 1328 93/42 Drill Stopper for Short L11.5 1332 93/42 Drill Stopper for Short L11.5 1336 93/42 Drill Stopper for Short L11.5 1342 93/42 Drill Stopper for Short L11.5 1352 93/42 Drill Stopper for Short L11.5 1356 93/42 Drill Stopper for Short L6 1336 93/42 Drill Stopper for Short L6 1342 93/42 Drill Stopper for Short L6 1346 93/42 Drill Stopper for Short L6 1356 93/42 Drill S-5.5, 3.85/3.2mmDx18.0mmL 93/42 Drill S-5.5, 4.6/3.85mmDx18.0mmL 93/42 Extra Long Pilot Drill 1.8/2.5mmD x 16-25mmL 93/42 Extra Long Pilot Drill 1.8/2.5mmD x 16-25mmL Twist Step Drill 3 refs Extra Long Twist Step Drill 3.2/3.6mmD x 16-25mmL 93/42 MB Guided Surgery Drills Kit 93/42 MB Tri-Step Drill Stop Kit 93/42 Pilot Drill 2mmD x 6-13mmL 2 refs Pilot Drill 2mmD x 8-18mmL 93/42 Pilot Drill S-5.5, 2.5/1.8mmDx6.0mmL Guided Surgery Pilot Drills Regular Long Drill Stop Kit 93/42 Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills 93/42 Three Step Drill-Long 93/42 Three Step Drill-Short Tip Drill MTD1 Twist Step Drill 1.8/2.5mmD x 8-18mmL 93/42 Twist Step Drill 2.3/2.8mmD x 6-13mmL 93/42 Twist Step Drill 2.3/2.8mmD x 8-18mmL 93/42 Twist Step Drill 2.8/3.2mmD x 6-13mmL 93/42 Twist Step Drill 2.8/3.2mmD x 8-18mmL 93/42 Twist Step Drill 3.2/3.6mmD x 8-18mmL 93/42 Twist Step Drill 3.2/3.9mmD x 6-13mmL Twist Step Drill 1 2 refs Twist Step Drill 3.8/4.2mmD x 6-13mmL 93/42 Twist Step Drill 3.8/4.2mmD x 8-18mmL 93/42 Twist Step Drill 4.2/4.6mmD x 6-13mmL 93/42 Twist Step Drill 4.2/4.6mmD x 8-18mmL 93/42 Twist Step Drill 4.8/5.2mmD x 8-18mmL 93/42 Twist Step Drill 5.2/5.6mmD x 6-13mmL 93/42 Twist Step Drill 5.2/5.6mmD x 8-18mmL 93/42 Wide Short Drill Stop Kit 93/42
I, IIa
MDR, 93/42
office@medigma-implants.com
EUDAMED record
Report an error
Daddy D Pro FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
87 others
I
93/42
Website
export@daddydpro.com
EUDAMED record
Report an error
A&D FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
85 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Being Foshan Medical Equipment
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
85 others
IIa
MDR, 93/42
EUDAMED record
Report an error
Orantech FDA
EU representative : Medten EU ApS (Denmark)
China
85 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Cardioline FDA
Italy
84 others
I, IIa
MDR, 93/42
Website
compliance@cardioline.com
EUDAMED record
Report an error
Heine FDA
Germany
84 others
I
MDR
Website
info@heine.com
EUDAMED record
Report an error
Draeger FDA
EU representative : Drägerwerk AG & Co. KGaA (Germany)
China, Germany, United States
111 others Babyroo TN300 1306013VK19Z00 Babyroo TN300 306012VK19Z000 BiliLux 094900 93/42 C2000 Isolette 000222 93/42 CO2-Sensor Savina 300 365556 93/42 D-Vapor 225195 93/42 D-Vapor 3000 301370 93/42 Dosiermodul D 229834 93/42 Dosiermodul I 229797 93/42 Dosiermodul S 229810 93/42 Dräger Jaundice Meter JM-105 1206014VK19Z00 Dräger Jaundice Meter JM-105 206071VK19Z000 Evita V600 304022FK19Z000 2 refs EXC Dosiermodul D 565154 93/42 Fabius MRI 041498 93/42 Hauttemp.-Sensor3,Dual,EW,BX10 031646 93/42 Hauttemp.-Sensor5, gr .,BX10 029247 93/42 HEMOMED POD 008549 93/42 IACS Monitoring with C700 307028XK13Z010 IBP Adapter Cable Drager 10pin 1080566K19Z000 3 refs Infinity Acute Care System C500 2307028XK13Z00 Infinity Central Station Wide 307006XK19Z000 INFINITY M300 BEDSIDE CHARGER 307005VK13K010 3 refs INFINITY MASIMO SP02 POD USB 050739 93/42 INFINITY MASIMO SPO2 POD X8 050746 93/42 INFINITY MCABLE DUAL HEMO 307028VK19K010 2 refs INFINITY MPOD-QUAD HEMO 307035VK16K010 Infinity Nellcor SpO2 Pod X8 049306 93/42 INFINITY® M540 307028XK13Z020 3 refs Isolette 8000 plus 090612 93/42 M540 HEMO-VERBIND.KABEL 1.5M 1307035XK12Z01 2 refs MCable-Mainstream CO2 053686 93/42 NBP Anschlussschlauch, Erw 3,7m 1080036K19Z000 3 refs NIBP Neo #1 Mansch 3,1-5,7cm 1070246K19Z000 NIBP Neo #2 Mansch 4,3-8cm 1070246K19Z010 NIBP Neo #3 Mansch 5,8-10,9cm 1070246K19Z020 NIBP Neo #4 Mansch 7,1-13,1cm 1070246K19Z030 NIBP Neo #5 Mansch 8,3-15cm 1070246K19Z040 NIBP-Schlauch,neonat. Manschetten, 2,4 m 1070246K19Z050 NMT-KABEL TRIDENT, 2-ADR, 0,3M 1070276K19Z530 NMT-THERMISTOR TRIDENT 1070276K19Z540 OR-PC 24 for Vista CMS 383000 93/42 Oxylog 3000 plus 304015FK19Z000 2 refs Perseus A500 301031FK19Z000 POD MULTIMED 12-Lead + SpO2 008525 93/42 Polaris 103032XK19Z000 PROBE 1,SKIN TEMP,REUSABLE 038003 93/42 PROBE 3,SKIN TEMP,REUSABLE 031653 93/42 PROBE 5,SKIN TEMP,REUSABLE 029292 93/42 PROBE,SKIN TEMP,CENTRL,BX10 446866 93/42 PROBE,SKIN TEMP,PERPH,BX 10 446842 93/42 Prüfkopf 1,Hauttemperatur 10 038058 93/42 PulmoVista 500 1204026VK19Z00 PulmoVista 500 252603 93/42 Savina 300 411628 93/42 Savina 300, System 251422 93/42 Seattle PAP 308041XK19Z000 2 refs SHP UNT INFINITY CNAP POD 050685 93/42 SPO2 DRÄGER ERN. SCHAUM, 24STK 005357 93/42 SPO2 DRÄGER ERW. VINYL, 24STK 005319 93/42 SPO2 DRÄGER NERO BAND, 24 STK 005340 93/42 SPO2 DRÄGER PÄD. SCHAUM, 24STK 005364 93/42 SPO2 DRÄGER PÄD. VINYL, 24STK 005326 93/42 SPO2 DRÄGER SÄUGL. BAND, 24STK 005333 93/42 SPO2-Sensor, Dräger, Mehrweg 007016 93/42 SUCTION BOTTL,800mL,DISP,BOX20 1061016K19Z000 Transportinkubator 500 000208 93/42 Vapor 2000 228059 93/42 Vapor 3000 301363 93/42 VarioLux AUS 108033XK19Z000 3 refs Vista 120 C.O. Model C 548089 93/42 Vista 120 Nellcor Model A 548096 93/42 Vista 120 Nellcor Model C 557500 93/42 Vista 120 Non-Inv Model A 548072 93/42 Vista 120 SC Model A Br 307003VK19Z000 3 refs Vista 120/S Monitor 566151 93/42 Vista 120S C.O. model C 438892 93/42 Vista 120S C.O. Nellcor model C+ 441014 93/42 Vista 120S neinvazivní, model A 438885 93/42 Vista 120S Nellcor Model A 441007 93/42 Vista 300 Invasive Model C 3 refs Vista Telemetry T100 Model A 4307009VK19Z00 3 refs Zeus IE 248934 93/42 Babytherm 8004 041382 93/42 (no longer marketed) Babytherm 8010 017097 93/42 (no longer marketed) BT 8004 100-240V 419228 93/42 (no longer marketed) BT 8010 100-240V 246558 93/42 (no longer marketed) CNAP CUFF CONTROLLER CABLE 005722 93/42 (no longer marketed) CNAP SENSOR CUFF, SMALL 005715 93/42 (no longer marketed) CNAP SENSORMANSCHETTE, L 005692 93/42 (no longer marketed) CNAP SENSORMANSCHETTE, M 005708 93/42 (no longer marketed) CO2 Hauptstromsensor 204024VK19Z000 (no longer marketed) Delta Monitor 004152 93/42 (no longer marketed) DeltaXL Monitor 004169 93/42 (no longer marketed) Dräger Isolette 8000 000178 93/42 (no longer marketed) Evita V300 389354 93/42 (no longer marketed) Fabius GS premium 041467 93/42 (no longer marketed) Fabius Plus 041481 93/42 (no longer marketed) Fabius Plus XL 377610 93/42 (no longer marketed) Fabius Tiro 041474 93/42 (no longer marketed) Fabius Tiro D-M 251002 93/42 (no longer marketed) Infinity Explorer Monitor 004060 93/42 (no longer marketed) Infinity Kappa Monitor 004039 93/42 (no longer marketed) Infinity Omega Monitor 002738 93/42 (no longer marketed) Oxylog VE300 304019FK19Z000 (no longer marketed) Primus 041436 93/42 (no longer marketed) Primus IE 224747 93/42 (no longer marketed) Resuscitaire 000215 93/42 (no longer marketed) Savina System 016403 93/42 (no longer marketed) Workstation Critical Care 042266 93/42 (no longer marketed) Workstation NC 250418 93/42 (no longer marketed)
I, IIa, IIb
MDR, 93/42
Website
EUDAMED@draeger.com
EUDAMED record
Report an error
Urion FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
China
82 others ALPHAMED U60B 2 refs 93/42 ALPHAMED U60CH 93/42 ALPHAMED U60E 2 refs 93/42 AlphaMed U60GH 93/42 Alphamed U62GH 93/42 ALPHAMED U62I 93/42 AlphaMed U807 93/42 ALPHAMED U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models 3 refs ALPHAMED U80E 2 refs 93/42 ALPHAMED U80EH 2 refs 93/42 ALPHAMED U81K 93/42 ALPHAMED U81RH 93/42 ALPHAMED U81V 2 refs 93/42 Alphamed U81Y 93/42 ALPHAMED U82RH 93/42 ALPHAMED U82V 93/42 ALPHAMED U82W 93/42 ALPHAMED U83H 93/42 AlphaMed U83Y 93/42 AlphaMed U83Z 93/42 ALPHAMED U85H 93/42 ALPhamed U86E 93/42 AlphaMed U86WH 93/42 ALPHAMED U87E 93/42 ALPhamed U90B 93/42 Alphamed U90B Plus U90B, U90B Pro, U90B PIus, U90B Ultra, U90C, U90C Pro, U90C Plus, U90C Ultra 3 refs AlphaMed U90E 93/42 Alphamed U90F 93/42 ANOVATOR U807 93/42 Anriwell AW-301 U80EH 93/42 Autonomie et Bien être U60EH 93/42 autonomie et bien être U80H 93/42 Axets U63I 93/42 Axets U81V 93/42 BP MeasureX U80EH 93/42 BP MeterX U80N 93/42 Ciśnieniomierz naramienny DIATHER Care U87E 2 refs 93/42 Dr.Mayer U60CH 93/42 Dr.Mayer U80EH 93/42 ELERA U81E 93/42 Farmadosis U80R 93/42 HeartiPro U80N 93/42 HERTIPRO U80Y 93/42 HUGO-MED U81E 93/42 Jnx|Med U80N 93/42 JOOPHYS U80R 93/42 L2N U80M 93/42 L2N U81Q 93/42 L2N U87E 93/42 L2N Wrist Electronic Blood Pressure Monitor U62GH, U65H, U61GH, U60H, U61H, U62H, U63H, U67H, U68H, U60BH, U60K, U60B, U60CH, U60C, U60EH, U60E, U60I, U62I, U63I, U60GH, U60G 3 refs Life Net U80EH 93/42 Meds MEDICAL SOLUTIONS U81V 93/42 Meds MEDICAL SOLUTIONS U90B 93/42 misure U81D 3 refs 93/42 Misure U81RH 2 refs 93/42 Misure U82RH 3 refs 93/42 Misure U90B 2 refs 93/42 Novacardix U80EH 93/42 NOVΛCARDIX U80EH 93/42 ORAVA U82RH 93/42 ORTHOVISIONS U61H 93/42 promed U80LH 93/42 PVS FIRST AID U80E 93/42 Redcare U81M 93/42 ROTOPATA U87E 93/42 SANGOOL U63H 93/42 sanitayaki U63I 93/42 sanitayaki U81CH 93/42 sanitayaki U81Q 93/42 santecare U60E 93/42 SDUNW U80Z 93/42 SDUNW U81V 93/42 SimplyMED+ U63I 2 refs 93/42 SimplyMED+ U80EH 93/42 SimplyMED+ U82RH 2 refs 93/42 Stepcare U90B 93/42 SUNALE U80C 93/42 U80B 93/42 U82V 93/42 U82V, Elektroniczny ciśnienia NARAMIENNY, depan 2 refs 93/42 URION U80EH 93/42 WADEO U61H 93/42
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Karlstorz FDA
Germany
78 others Aspirators 10432N Atomizers, bronchoscopy Atomizes, ear surgery, metal Audio/Video management units Battery light sources, intubation endoscopes 11301D1 2 refs Battery light sources, telescopes Camera control units TC100 3 refs Cold loops 26053R Combination devices TP101 Compact telescopes, suction/irrigation 3 refs Connecting cables 3 refs Documentation management appliances 2 refs Fiber optic light carriers, mediastinoscopy Flexible bronchoscopes, working channel Flexible endoscopes 11001RD1 Flexible endoscopes, sterile, single use 2 refs Flexible endoscopes, SW Flexible fiberscopes, irrigation Flexible intubation endoscopes, suction/irrigation channel, sterile, single use 2 refs Flexible intubation endoscopes, SW Flexible intubation endoscopes, working channel, sterile, single use 3 refs Flexible video bronchoscopes 11910D Flexible video choledochoscopes Flexible videoendoscopes Flexible videoendoscopes, sterile, single use 3 refs Headlights 2 refs HF generators Image/video transmitters WO400-01 Imagers 8403XSB 3 refs Input devices TC014 Insufflators Insufflators, heating Insufflators, heating, smoke evacuation Interface modules, operating tables WU10000 Lamp heads 2 refs Lamp heads, fiber optic 3 refs Laryngoscopes, metal 8574C Laryngoscopes, metal, plastics 8590JV Laser units UL300 Mechanical lithotripters 27076A 2 refs Monitors, video laryngoscopes 8403XD 2 refs Motor control units NIR Fluorescence light sources Non-flexible intubation endoscopes 10331B2 Non-flexible intubation endoscopes, SW PDD fluorescence light source Protectors 8596OJ Rigid esophagoscopes 2 refs Rigid telescopes 3 refs Rigid videoendoscopes, laparoscopy Semirigid telescopes 3 refs Shaver blades, urology Sheaths, irrigation/suction, nephroscopy Sheaths, nephroscopy Sockets 3 refs Suction/Irrigation Pumps UP220 Telescopes, arthroscopy Telescopes, bronchoscopy Telescopes, channel Telescopes, hysteroscopy 2 refs Telescopes, irrigation, hysteroscopy Telescopes, laparoscopy 3 refs Telescopes, laryngoscopy 3 refs Telescopes, otology 3 refs Telescopes, proctology 2 refs Telescopes, urology 3 refs Telescopes, urology, natural body orifices 3 refs Telescopes, working channel, metal 2 refs Touch screens Transport systems UG055 Transport systems UG500 3 refs Transport systems, active UG040 3 refs Valves UP501 Video laryngoscopes 8404AX 3 refs White light camera heads TH110 3 refs White Light/FI camera heads 3 refs White-light light sources White-light light sources, SW 2 refs
I, IIa, IIb
MDR
Website
regulatory@karlstorz.com
EUDAMED record
Report an error
Olympus FDA
EU representative : Olympus Europa SE & Co. KG (Germany)
Japan
75 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Ritim Grup Tibbi Cihazlar Elektronik Sanayi Ve Ticaret Anonim Sirketi
Türkiye
75 others
III
93/42
Website
info@ritimport.com
EUDAMED record
Report an error
Foras
Türkiye
73 others
IIa, IIb
93/42
Website
info@foras.com.tr
EUDAMED record
Report an error
Contecmed FDA
EU representative : Prolinx GmbH (Germany)
China
72 others Dynamic ECG Systems TLC5000, TLC6000 2 refs ECG Workstation CONTEC8000G Electrocardiograph ECG100G 93/42 Electrocardiograph ECG1212G, ECG90A, ECG300G, ECG600G, ECG1200G, E3, E3M, E6, E12, E18M 3 refs Electrocardiograph ECG300GT 93/42 Electronic Sphygmomanometer BP-100 93/42 Electronic Sphygmomanometer CONTEC07A Electronic Sphygmomanometer CONTEC08A Electronic Sphygmomanometer CONTEC08A-BT 93/42 Electronic Sphygmomanometer CONTEC08C Electronic Sphygmomanometer CONTEC08D 93/42 Electronic Sphygmomanometer CONTEC08E 93/42 EMG/EP System CMS6600B, CMS6600 2 refs Fetal Monitor CMS800G Infusion Pump SP750 Mesh Nebulizer IN-100 93/42 Mesh Nebulizer NE-M01, NE-M01L 2 refs Mesh Nebulizer NE-M03 93/42 Mesh Nebulizer NE-M03A 93/42 Mesh Nebulizer NE-M03B 93/42 Oxygen Concentrator CONTEC21 Patient Monitor CMS6000 93/42 Patient Monitor CMS7000 93/42 Patient Monitor CMS8000 93/42 Patient Monitor CMS9000 93/42 Pocket Fetal Doppler Baby Sound A 93/42 Pocket Fetal Doppler Baby Sound B 93/42 Pocket Fetal Doppler Baby Sound C 93/42 Pocket Fetal Doppler Baby Sound C1 93/42 Pocket Fetal Doppler CONTEC10A 93/42 Pocket Fetal Doppler CONTEC10B 93/42 Pocket Fetal Doppler CONTEC10C, CONTEC10CL 2 refs Pocket Fetal Doppler Sonoline C 93/42 Portable ECG Monitor PM10 Pulse Oximeter ANP100 93/42 Pulse Oximeter CMS50-Pro 93/42 Pulse Oximeter CMS50D+ 93/42 Pulse Oximeter CMS50D-BT 93/42 Pulse Oximeter CMS50D1 93/42 Pulse Oximeter CMS50D2 93/42 Pulse Oximeter CMS50D2-1 93/42 Pulse Oximeter CMS50DL, CMS50D 2 refs Pulse Oximeter CMS50DL1 93/42 Pulse Oximeter CMS50DL2 93/42 Pulse Oximeter CMS50E 93/42 Pulse Oximeter CMS50F 93/42 Pulse Oximeter CMS50I 93/42 Pulse Oximeter CMS50M 93/42 Pulse Oximeter CMS50N 93/42 Pulse Oximeter CMS50Q1 93/42 Pulse Oximeter CMS50QA 93/42 Pulse Oximeter CMS50QB 93/42 Pulse Oximeter CMS60C 93/42 Pulse Oximeter CMS60D 93/42 Pulse Oximeter CMS60D1 93/42 Pulse Oximeter CMS70A 93/42 Pulse Oximeter NX-8740-675 93/42 Pulse Oximeter PO-100 93/42 Pulse Oximeter PO-200 93/42 Pulse Oximeter PO-200A Solo 93/42 Pulse Oximeter PO-200Solo 93/42 Pulse Oximeter PO-230 93/42 Pulse Oximeter PO-250 93/42 Pulse Oximeter PO-300 93/42 Pulse Oximeter PO-400 93/42 Pulse Oximeter PO-650A 93/42 Pulse Oximeter PO-650B 93/42 Pulse Oximeter PO-900 93/42 Pulse Oximeter SAT-500 93/42 Spirometer SP10 93/42 SPIROMETER SP80B Video Laryngoscope CMS-GS1
I, IIa, IIb
MDR, 93/42
Website
pms.qms@contecmed.com
EUDAMED record
Report an error
Sonoscape FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
72 others
I, IIa, IIb
MDR
ra@sonoscape.net
EUDAMED record
Report an error
SLE
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
71 others
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Intercus
Germany
70 others GNp Kanülierter Bohrer D 5,0 mm Verriegelung langer Nägel 93/42 GNp Stoppbohrer Verriegelung 93/42 Kopfraumbohrer, durchbohrt, für CLAVIUS-Schrauben D 5,5 mm, L 160 mm, mit Dreikantschaft 93/42 Kopfraumbohrer, durchbohrt, für CONTUS-Schrauben D 7,5 mm, L 160 mm, mit Dreikantschaft 93/42 Kopfraumbohrer, durchbohrt, für durchbohrte Schrauben D 3,0 mm, für Schnellkupplung 93/42 Kopfraumbohrer, durchbohrt, für durchbohrte Schrauben D 4,0 mm, für Schnellkupplung 93/42 Kopfraumbohrer, durchbohrt, für EPIUS-Schrauben D 4,0 mm, L 160 mm, für Schnellkupplung 93/42 Kopfraumbohrer, für CIRRUS-Schrauben mini D 2,3 mm, ID 1,0 mm, L 65 mm, für Schnellkupplung 93/42 Kopfraumbohrer, für Schrauben D 1,5 mm, D 2,0 mm, Dentalkupplung 93/42 Kopfraumbohrer, für Schrauben D 2,7 mm, D 3,5 mm, D 4,0 mm, für Schnellkupplung 93/42 Kopfraumbohrer, für Schrauben D 4,5 mm, D 6,5 mm, Schnellkupplung 93/42 Spiralbohrer, dreilippig, D 2,5 mm, GL 175 mm, mit Dreikantschaft 93/42 Spiralbohrer, dreilippig, D 3,5 mm, GL 210 mm, mit Dreikantschaft 93/42 Spiralbohrer, durchbohrt, D 2,5 mm, ID 1,35 mm, GL 160 mm, für Schnellkupplung 93/42 Spiralbohrer, durchbohrt, D 3,2 mm, ID 1,7 mm, GL 160 mm, für Schnellkupplung 93/42 Spiralbohrer, durchbohrt, D 3,5 mm, ID 1,35 mm, GL 160 mm, Schnellkupplung 93/42 Spiralbohrer, durchbohrt, D 3,5 mm, ID 1,8 mm, GL 160 mm, Schnellkupplung 93/42 Spiralbohrer, durchbohrt, D 3,5 mm, ID 1,8 mm, GL 195 mm, Schnellkupplung 93/42 Spiralbohrer, durchbohrt, D 4,5 mm, ID 2,1 mm, GL 230 mm, mit Dreikantschaft 93/42 Spiralbohrer, durchbohrt, D 5,5 mm, ID 2,7 mm, GL 190 mm, mit Dreikantschaft 93/42 Spiralbohrer, durchbohrt, D 5,5 mm, ID 2,7 mm, GL 250 mm, mit Dreikantschaft 93/42 Spiralbohrer, zweilippig, D 1,1 mm, GL 60 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 1,5 mm, GL 105 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 1,5 mm, GL 125 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 1,5 mm, GL 125 mm, mit Zylinderschaft 93/42 Spiralbohrer, zweilippig, D 1,5 mm, GL 65 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 1,5 mm, GL 88 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,0 mm, GL 105 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,0 mm, GL 125 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,0 mm, GL 125 mm, mit Zylinderschaft 93/42 Spiralbohrer, zweilippig, D 2,0 mm, GL 150 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,0 mm, GL 160 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,0 mm, GL 65 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,5 mm, GL 105 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,5 mm, GL 125 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,5 mm, GL 125 mm, mit Zylinderschaft 93/42 Spiralbohrer, zweilippig, D 2,5 mm, GL 150 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,5 mm, GL 160 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,5 mm, GL 175 mm, mit Dreikantschaft 93/42 Spiralbohrer, zweilippig, D 2,7 mm, GL 100 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 2,7 mm, GL 125 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 3,2 mm, GL 145 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 3,2 mm, GL 195 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 3,2 mm, GL 250 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 3,2 mm, GL 250 mm, mit Dreikantschaft 93/42 Spiralbohrer, zweilippig, D 3,2 mm, GL 250 mm, mit Messfunktion, für Bohrsystem 750.104521 93/42 Spiralbohrer, zweilippig, D 3,5 mm, GL 110 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 3,5 mm, GL 195 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 3,5 mm, GL 210 mm, mit Dreikantschaft 93/42 Spiralbohrer, zweilippig, D 4,0 mm, GL 195 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 4,0 mm, GL 220 mm, für Schnellkupplung 93/42 Spiralbohrer, zweilippig, D 4,0 mm, GL 250 mm, mit Dreikantschaft 93/42 Spiralbohrer, zweilippig, D 4,5 mm, GL 145 mm, für Schnellkupplung 93/42 Vorbohrer, durchbohrt, D 2,4 mm, für durchbohrte Schrauben D 3,0 mm, für Schnellkupplung 93/42 Vorbohrer, durchbohrt, D 2,4 mm, ID 1,5 mm, GL 100 mm, mit Messskala und Schnellkupplung 93/42 Vorbohrer, durchbohrt, D 2,9 mm, ID 1,7 mm, für EPIUS-Schrauben, für Schnellkupplung 93/42 Vorbohrer, durchbohrt, D 3,0 mm, für durchbohrte Schrauben D 4,0 mm, D 4,5 mm, für Schnellkupplung 93/42 Vorbohrer, durchbohrt, D 3,0 mm, ID 1,7 mm, GL 90 mm, für Schrauben L 26 mm, selbstschneidend 93/42 Vorbohrer, durchbohrt, D 3,0 mm, ID 1,7 mm, GL 90 mm, für Schrauben L 36 mm, selbstschneidend 93/42 Vorbohrer, durchbohrt, D 3,0 mm, ID 1,7 mm, GL 90 mm, für Schrauben L 46 mm, selbstschneidend 93/42 Vorbohrer, durchbohrt, D 3,0 mm, ID 1,8 mm, GL 100 mm, mit Zylinderschaft 93/42 Vorbohrer, durchbohrt, für CIRRUS-Schrauben, für Schnellkupplung 93/42 Vorbohrer, durchbohrt, für INCUS/CIRRUS, D 1,6 mm, ID 0,9 mm, GL 65 mm, für Schnellkupplung 93/42 Vorbohrer, mit Kopfraumfräser, durchbohrt, für CIRRUS-Schrauben ab Länge 20 mm, Schnellkupplung 93/42 Vorbohrer, mit Kopfraumfräser, durchbohrt, für CIRRUS-Schrauben ab Länge 30 mm, Schnellkupplung 93/42 Vorbohrer, mit Kopfraumfräser, durchbohrt, für CIRRUS-Schrauben ab Länge 9 mm, Schnellkupplung 93/42 XS kanülierter Bohrer D 4,5 mm/ID 2,0 mm 93/42 XS Spiralbohrer für lange Nägel D 4,5 mm 93/42 XXS kanülierter Bohrer D 3,5 mm/ID 1,6 mm 93/42 XXS Spiralbohrer für lange Nägel D 3,5 mm 93/42
IIa
93/42
info@intercus.de
EUDAMED record
Report an error
PENTAX Medical FDA
EU representative : PENTAX Europe GmbH (Germany)
Japan
73 others
I, IIa
MDR, 93/42
Website
info.emea@pentaxmedical.com
EUDAMED record
Report an error
Intco FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany) and 1 other
China
67 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Medical Consult Implants
Germany
67 others Einbringinstrument für Mini-Kugelkopf-Implantat & DAAS Rotating 93/42 Gewindeschneider für S&T Ø 3,3 93/42 Gewindeschneider für Straight Ø 4,1 93/42 Gewindeschneider für Straight Ø 4,5 93/42 Gewindeschneider für Straight Ø 5,0 93/42 Gewindeschneider für Straight Ø 5,5 93/42 Gewindeschneider für Tapered Ø 3,8 93/42 Gewindeschneider für Tapered Ø 4,1 93/42 Gewindeschneider für Tapered Ø 4,5 93/42 Gewindeschneider für Tapered Ø 5,5 93/42 Implantateinbringer, kurz, Ø 3,3 (gelb) Rotating 93/42 Implantateinbringer, kurz, Ø 3,8/4,1 (grau) Rotating 93/42 Implantateinbringer, kurz, Ø 4.5/5.0 (orange) Rotating 93/42 Implantateinbringer, kurz, Ø 5,5 (rot/violett) Rotating 93/42 Implantateinbringer, lang, Ø 3,3 (gelb) Rotating 93/42 Implantateinbringer, lang, Ø 3,8/4,1 (grau) Rotating 93/42 Implantateinbringer, lang, Ø 4,5 (blau) Rotating 93/42 Implantateinbringer, lang, Ø 4.5/5.0 (orange) Rotating 93/42 Pilotbohrer Straight Ø 2,0mm 93/42 Safety Stopp Finalbohrer f. Tapered 3,8 (Ø 3,25x10mm) 93/42 Safety Stopp Finalbohrer f. Tapered 3,8 (Ø 3,25x11,5mm) 93/42 Safety Stopp Finalbohrer f. Tapered 3,8 (Ø 3,25x13mm) 93/42 Safety Stopp Finalbohrer f. Tapered 3,8 (Ø 3,25x14,5mm) 93/42 Safety Stopp Finalbohrer f. Tapered 4,1 (Ø 3,7 x 14,5mm) 93/42 Safety Stopp Finalbohrer f. Tapered 4,1 (Ø 3,7 x10mm) 93/42 Safety Stopp Finalbohrer f. Tapered 4,1 (Ø 3,7 x13mm) 93/42 Safety Stopp Finalbohrer f. Tapered 4,5 (Ø 4,2x11,5mm) 93/42 Safety Stopp Finalbohrer f. Tapered 4,5 (Ø 4,2x13mm) 93/42 Safety Stopp Finalbohrer f. Tapered 5,0 (Ø 4,7x11,5mm) 93/42 Safety Stopp Finalbohrer f. Tapered 5,0 (Ø 4,7x13mm) 93/42 Safety Stopp Finalbohrer f. Tapered 5,0 (Ø 4,7x14,5mm) 93/42 Safety Stopp Finalbohrer f. Tapered 5,5 (Ø 5,3x10mm) 93/42 Safety Stopp Finalbohrer für Tapered 4,5 (Ø 4,2 x 14,5mm) 93/42 Safety Stopp Pilotbohrer Ø 2,0x11,5mm 93/42 Safety Stopp Pilotbohrer Ø 2,0x13mm 93/42 Safety Stopp Pilotbohrer Ø 2,0x14,5mm 93/42 Safety Stopp Spiralbohrer f. S&T Ø 2,8x10mm 93/42 Safety Stopp Spiralbohrer f. S&T Ø 2,8x11,5mm 93/42 Safety Stopp Spiralbohrer f. S&T Ø 2,8x13mm 93/42 Safety Stopp Spiralbohrer f. S&T Ø 2,8x14,5mm 93/42 Safety Stopp Spiralbohrer f. Straight 3,8 (Ø 3,25x10mm) 93/42 Safety Stopp Spiralbohrer f. Straight 3,8 (Ø 3,25x11,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 3,8 (Ø 3,25x13mm) 93/42 Safety Stopp Spiralbohrer f. Straight 3,8 (Ø 3,25x14,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 4,1 (Ø 3,7x10mm) 93/42 Safety Stopp Spiralbohrer f. Straight 4,1 (Ø 3,7x11,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 4,1 (Ø 3,7x13mm) 93/42 Safety Stopp Spiralbohrer f. Straight 4,1 (Ø 3,7x14,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 4,5 (Ø 4,25x13mm) 93/42 Safety Stopp Spiralbohrer f. Straight 4,5 (Ø 4,25x14,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,0 (Ø 4,7x10mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,0 (Ø 4,7x11,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,0 (Ø 4,7x13mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,0 (Ø 4,7x14,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,5 (Ø 5,3 x 10mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,5 (Ø 5,3 x 11,5mm) 93/42 Safety Stopp Spiralbohrer f. Straight 5,5 (Ø 5,3 x 13mm) 93/42 Tiefenbohrer für Straight 4,5 (Ø 4,25mm) 93/42 Tiefenbohrer für Straight 5,0 (Ø 4,7mm) 93/42 Tiefenbohrer für Straight Ø 2,8mm 93/42 Tiefenbohrer für Straight Ø 3,25mm 93/42 Tiefenbohrer für Tapered 3,8 (Ø 3,25mm) 93/42 Tiefenbohrer für Tapered 4,1 (Ø 3,7mm) 93/42 Tiefenbohrer für Tapered 4,5 (Ø 4,2mm) 93/42 Tiefenbohrer für Tapered 5,5 (Ø 5,3mm) 93/42 Winkelstück-Inbus, kurz Rotating 93/42 Winkelstück-Inbus, lang Rotating 93/42
IIa
93/42
Website
EUDAMED record
Report an error
Quanta System FDA
Italy
66 others
IIb
MDR, 93/42
regulatory@quantasystem.com
EUDAMED record
Report an error
Richard Wolf FDA
Germany
65 others
I, IIa, IIb
MDR, 93/42
Website
info@richard-wolf.com
EUDAMED record
Report an error
Deka
Italy
64 others
IIa, IIb
MDR, 93/42
Website
info@deka.it
EUDAMED record
Report an error
Beijing Choice Electronic Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
63 others M-50B 93/42 M-50C 93/42 M-50E 93/42 MD2000A 93/42 MD2000B 93/42 MD2000C 93/42 MD300K2 93/42 MD300M 93/42 MD300W628 93/42 ME5 93/42 Oxygen concentrator OCB-5,OCB-5R 2 refs Oxygen concentrator OCB-5RN Oxygen concentrator OCP-4 3 refs PM A10 93/42 PM A19 93/42 PO 45 93/42 Pulse Oximeter MD300C13 93/42 Pulse Oximeter MD300C19 93/42 Pulse Oximeter MD300C2 93/42 Pulse Oximeter MD300C203 93/42 Pulse Oximeter MD300C208 93/42 Pulse Oximeter MD300C21 93/42 Pulse Oximeter MD300C22 93/42 Pulse Oximeter MD300C228 93/42 Pulse Oximeter MD300C23 93/42 Pulse Oximeter MD300C26 93/42 Pulse Oximeter MD300C29 93/42 Pulse Oximeter MD300C41 93/42 Pulse Oximeter MD300C5 93/42 Pulse Oximeter MD300C52 93/42 Pulse Oximeter MD300C53 93/42 Pulse Oximeter MD300C54 93/42 Pulse Oximeter MD300C55 93/42 Pulse Oximeter MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, OX200 3 refs Pulse Oximeter MD300CI216 93/42 Pulse Oximeter MD300CI216R, MD300CI218R 2 refs Pulse Oximeter MD300CI218 93/42 Pulse Oximeter MD300CN130 93/42 Pulse Oximeter MD300CN140 93/42 Pulse Oximeter MD300CN150 93/42 Pulse Oximeter MD300CN160 93/42 Pulse Oximeter MD300CN310 93/42 Pulse Oximeter MD300CN330 93/42 Pulse Oximeter MD300CN330R, MD300CN350R, MD300CN356R 3 refs Pulse Oximeter MD300CN340 93/42 Pulse Oximeter MD300CN350 93/42 Pulse Oximeter MD300CN356 93/42 Pulse Oximeter MD300CN360 93/42 Pulse Oximeter MD300K2 93/42 Pulse Oximeter MD300K2N Pulse Oximeter MD300MNR Pulse Oximeter MD300W series 2 refs Pulse Oximeter OX200 93/42 Pulse Oximeter OXY300 93/42 Pulse Oximeter P300 Intelli IT(HPO-300T) 93/42 PX-100-EU 93/42 PX-101-EEU 93/42 PX-101-EU 93/42 TS 370PO 93/42 TS 380PO 93/42 Vital Sign Monitor MD2000A1 3 refs Vital Sign Monitor MD2000C 93/42 Wrist Pulse Oximeter MD300W628 93/42
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Philips FDA
EU representative : Philips Medical Systems Nederland B.V. (Netherlands) and 1 other
China, Germany, Netherlands, United States
76 others Adt Orl/Nsl CO2 Line w/O2 Conn STerm 93/42 Adt Orl/Nsl CO2 Line w/O2 Conn STerm Lng 93/42 Adt Orl/Nsl CO2 Line w/O2 LTerm 93/42 Adt Orl/Nsl CO2 Line w/O2 LTerm Lng 93/42 Adt Orl/Nsl CO2 Line w/O2 STerm 93/42 Adt/Med BiteBlk CO2 Line w/O2 Conn STerm 93/42 Adt/Med BiteBlk CO2 Line w/O2 STerm 93/42 Adt/Med BiteBlk CO2 Line w/O2 STerm Lng 93/42 ADULT FOAM ECG ELECTRODE, DISPOSABLE 3 refs ADULT NIBP AIR HOSE 3.0M 2 refs ATTACHMENT ELECTRODE AVALON CL BELT CLIP 4 refs Avalon CL Fetal & Maternal Patch Avalon FM20 Fetal Monitor FM20-50 93/42 Avalon FM30 Fetal Monitor FM20-50 93/42 Avalon FM40 Fetal Monitor FM20-50 93/42 Avalon FM50 Fetal Monitor FM20-50 93/42 Cardiac Workstation 5000/7000 2 refs Care Assist Android 2 refs CBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE Reusable Leadsets/ECG leads/SPO2 Cables 3 refs CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE IntelliVue MX40 Single-Patient-Use Cable 93/42 CBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele IntelliVue MX40 Single-Patient-Use Cable 93/42 COMFORT CARE CUFF, ADULT 3 refs DECG REUSABLE LEGPLATE ADAPTER PHILIPS EFFICIA 3-LEAD GRABBER, AAMI 3 refs FETAL SPIRAL ELECTRODE 93/42 G-Series patient monitor, Model is G30E 2 refs Heartstart FRx 93/42 HeartStart HS1 Defibrillator and Accs. 93/42 INFANT SINGLE-PATIENT CUFF SIZE #5 3 refs IntelliSpace ECG Management System IntelliVue Active Display AD75 AD75/AD85 Active Displays 2 refs IntelliVue MP5 93/42 IntelliVue Patient Monitor MP5SC 93/42 IntelliVue Patient Monitor MX400 MX400-550 3 refs IntelliVue Patient Monitor MX700 MX700/800 93/42 IntelliVue Patient Monitor MX750 MX750/850 2 refs IntelliVue Patient Monitor MX800 MX700/800 93/42 IntelliVue XDS Software Invasive Blood Pressure Module 93/42 MX40 - 2.4 MX40 Patient Wearable Monitor 93/42 MX40 - WLAN MX40 Patient Wearable Monitor 93/42 Nasal Alar SpO2 Sensor FAST Only, 20/CS Alar Nasal SpO2 Sensors 93/42 Nasal Alar SpO2 Sensor MLT CPTL, 24/CS Alar Nasal SpO2 Sensors 93/42 Neo/Inf Nsl CO2 Line w/O2 LTerm 93/42 NEONATAL NIBP AIR HOSE 1.5M 2 refs NEONATAL/PEDIATRIC SNAP ELECTRODE,SQUARE 3 refs PageWriter TC10 Cardiograph PageWriter TC35 Cardiograph Patient Information Center iX Patient Monitor 6100 Patient Monitor 6000 Series 3 refs Pedi Nsl CO2 Line w/O2 LTerm 93/42 Pedi Nsl CO2 Line w/O2 STerm 93/42 Pedi Orl/Nsl CO2 Line w/O2 LTerm 93/42 Pedi Orl/Nsl CO2 Line w/O2 LTerm Lng 93/42 Pedi Orl/Nsl CO2 Line w/O2 STerm 93/42 Pedi Orl/Nsl CO2 Line w/O2 STerm Lng 93/42 Philips Avent Electric Breast Pump 3 refs Philips Lumea 3 refs ST80i Stress Test System 12L Leadset, Grabber/Snaps IEC; 93/42 Telemetry Monitor 5500 VitalSky system 93/42 12L Leadset, Grabber, IEC 12L Leadset, Grabber/Snaps IEC; 2 refs (no longer marketed) Adt Nsl CO2 Line w/O2 LTerm 93/42 (no longer marketed) Adt Orl/Nsl CO2 Line w/O2 STerm Lng 93/42 (no longer marketed) BILECLIPSE, 50 PACK (no longer marketed) Bilical, 50 Pack (no longer marketed) DigiTrak XT Holter Recorder 93/42 (no longer marketed) E/R Temp Probe 10 FR Reuse Autoclavable 93/42 (no longer marketed) E/R Temp Probe 12 FR Reuse Autoclavable 93/42 (no longer marketed) Esophageal/Rectal Temperature Probe 93/42 (no longer marketed) PageWriter TC20 Cardiograph PageWriter TC30 Cardiograph 93/42 (no longer marketed) PageWriter TC30 Cardiograph 93/42 (no longer marketed) PageWriter TC50 Cardiograph PageWriter TC30 Cardiograph 93/42 (no longer marketed) PageWriter TC70 Cardiograph PageWriter TC30 Cardiograph 93/42 (no longer marketed) Skin Temp Probe Reusable Autoclavable 93/42 (no longer marketed)
I, IIa, IIb
MDR, 93/42
eudamed@philips.com
EUDAMED record
Report an error
Fiocchetti
Italy
62 others
IIa
93/42
Website
info@fiocchetti.it
EUDAMED record
Report an error
Technogym
Italy
61 others
I, IIa
MDR
prrc@technogym.com
EUDAMED record
Report an error
Micare FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
60 others
I
MDR
info@micare.cn
EUDAMED record
Report an error
Masimo FDA
EU representative : MDSS GmbH (Germany)
United States
59 others LiDCO Module 2 refs LiDCO to B. Braun, BP Module Cable 3 refs LiDCO to BNC, Analog Cable 3 refs Masimo SafetyNet Masimo SafetyNet, Radius PPG Chip 3 refs Masimo SET SpO Cable, E30 uSpO2 93/42 Masimo SET SpO Cable, USB uSpO2 93/42 Masimo SET Module, LNC 2 refs Masimo W1 MightySat 93/42 MightySat Rx 6 refs O3 Regional Oximeter 3 refs O3 Sensors 2 refs Pronto 3 refs 93/42 Pronto, (DCI SC-200) 93/42 Pronto, (DCI SC-200, DCIP SC-200) 93/42 Pronto, (DCI SC-400) 93/42 Pronto, (DCIP SC-200) 93/42 Pronto, (DCIP SC-400) 93/42 Rad-5 (Handheld) 93/42 Rad-5 (Handheld, International) 93/42 Rad-5 (Handheld, Refurbished) 93/42 Rad-5 (Handheld, with Sensor Sample Pack) 93/42 Rad-57 6 refs 93/42 Rad-57c 93/42 Rad-57cm 2 refs 93/42 Rad-5v (Handheld) 93/42 Rad-5v (Handheld, International) 93/42 Rad-5v (Handheld, Refurbished) 93/42 Rad-5v (Handheld, with Sensor Sample Pack) 93/42 Rad-5v Handheld, DCI, DCI-P 93/42 Rad-5v Handheld, Pediatric 93/42 Rad-67, Pulse CO-Oximeter (Spot-check) Rad-97 2 refs Rad-97 Home Use with noninvasive blood pressure 2 refs Rad-97 with NomoLine Capnography Rad-G 5 refs Radical-7 2 refs Radius PPG Kit, M20 2 refs Radius PPG Wireless Receiver 93/42 Radius VSM - ECG Electrode Adult 3-Lead 3 refs Radius VSM Disposable NIBP Cuff 3 refs Radius VSM Monitor Radius VSM with Reusable Pod & NIBP Radius-7 2 refs 93/42 rainbow SET COOximetry Module rainbow SET Module Carescape 2 refs 93/42 rainbow SET IntelliVue Module 2 refs 93/42 Rainbow Set Module 93/42 Rainbow Set Module for Welch Allyn 93/42 rainbow SET Pulse CO-Oximetry Cable, Carescape Sp02, Masimo, 0.9m Cable 93/42 rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo 93/42 Root, Masimo 93/42 Root, NIBP and Temperature SedLine 2 refs 93/42 SedLine Module 2 refs 93/42 smartSedLineTM Sedatoin Monitor 2 refs uSpO2 Pulse Oximetry Cable for GE ApexPro CH, CARESCAPE Telemetry T4 & T14 3 refs uSpO2 Masimo SET Oximetry Cable 6 refs 93/42 uSpO2 Masimo SET Oximetry Cable, USB 93/42
I, IIb
MDR, 93/42
Website
customerorders@masimo.com
EUDAMED record
Report an error
Erbe Vision FDA
Germany
58 others Bariatric Laparoscope, autocl. Ø 5.5mm 30°; 4K; WL 424mm 20860-XXX 93/42 Bariatric Laparoscope, autocl.Ø 5.5mm 45°; 4K; WL 425mm 20860-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 0° HD; WL 300mm 20864-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 12° HD; WL 300mm 20864-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 30° HD; WL 300mm 20864-XXX 93/42 Cystoscope, autoclavable, Ø 4mm; 70° HD; WL 300mm 20864-XXX 93/42 Hysteroscope, autoclavable, Ø 2.9mm; 0° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 2.9mm; 12° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 2.9mm; 30° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 0° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 12° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 30° HD; WL 300mm 20862-XXX 93/42 Hysteroscope, autoclavable, Ø 4mm; 70° HD; WL 300mm 20862-XXX 93/42 Inner sheath, cont.flow, diag. Ø 5.4mm; WL 260mm;for Ø 4mm 0° 20862-XXX 93/42 Inner sheath, cont.flow, diag. Ø 5.4mm;WL 260mm;for Ø 4mm 30° 20862-XXX 93/42 Inner sheath, diagnostic, Ø 4mm; WL 260mm; f. Ø2.9mm 30° 20862-XXX 93/42 Inner sheath, diagnostic, Ø 4mm; WL 260mm; for Ø2.9mm 0° 20862-XXX 93/42 Inner sheath, operating, for Ø 2,9mm 30° 20862-XXX 93/42 Inner sheath, operating, for Ø2.9mm 20862-XXX 93/42 Inner sheath, operating, sem-rig 5CH instrument channel 20862-XXX 93/42 Inner sheath, resectoscope, 24CH; for Ø 4mm 20862-XXX 93/42 Inner sheath,resectoscope,mini 17.5CH; for Ø 2.9mm 20862-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 0°; 4K; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 0°; HD; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 0°;4K NIR; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 30°; 4K NIR; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 30°; 4K; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 30°; HD; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 45°; 4K NIR; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 45°; 4K; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 10mm 45°; HD; WL 330mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 0°; 4K NIR; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 0°; 4K; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 0°; HD; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 30°; 4K NIR; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 30°; 4K; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 30°; HD; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 45°; 4K NIR; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 45°; 4K; WL 300mm 20860-XXX 93/42 Laparoscope, autoclavable, Ø 5.5mm 45°; HD; WL 300mm 20860-XXX 93/42 LED 610 Light source 3 refs Outer sheath, cont.flow, diag. Ø5mm;WL 240mm;f. Ø2.9mm 0°&30° 20862-XXX 93/42 Outer sheath, cont.flow, diag. Ø6.5mm;WL 240mm;f. Ø4mm 0°&30° 20862-XXX 93/42 Outer sheath, cont.flow, oper. Ø 6.3mm; WL 192mm; for Ø 2.9mm 20862-XXX 93/42 Outer sheath, cont.flow, oper. Ø 6.5mm;WL 192mm;for Ø 4mm 30° 20862-XXX 93/42 Outer sheath, resectoscope, round holes, 26CH; for Ø 4mm 20862-XXX 93/42 Outer sheath,resectoscope,mini cont.flow., 18.5CH;for Ø2.9mm 20862-XXX 93/42 Sheath for resectoscope, oblique tip, 24 CH 20862-XXX 93/42 Sheath, cont. flow, operating, Ø 8mm; WL 200mm;for Ø 4mm 0° 20862-XXX 93/42 Sheath, cont. flow, operating, Ø 8mm; WL 200mm;for Ø 4mm 30° 20862-XXX 93/42 Sheath,single flow,diagnostic Ø 4mm; WL 270mm; f. Ø2.9mm 30° 20862-XXX 93/42 Sheath,single flow,diagnostic Ø 4mm; WL 270mm; for Ø2.9mm 0° 20862-XXX 93/42 VIRON 1 Camera control unit 3 refs Working element bip. ,active, 26/24CH, w. protection rod 20862-XXX 93/42 Working element bip. ,passive, 26/24CH, w. protection rod 20862-XXX 93/42 Working element mono.,active, 26/24CH, w. protection rod 20862-XXX 93/42 Working element mono.,passive, 26/24CH, w. protection rod 20862-XXX 93/42 Working element, mini, bipolar passive,18.5CH 20862-XXX 93/42
I, IIa, IIb
MDR, 93/42
Website
info.vision.de@erbegroup.com
EUDAMED record
Report an error
Hpcosmos FDA
Germany
58 others COSMED T250 MR treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 250CE 170/65 treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 LE 300CE 170/65 treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 LE 500CE 170/65 treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 LE 580CE 200/75 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 580CE 200/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 590CE 200/100 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 590CE 200/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 600CE 250/75 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 600CE 250/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 650CE 250/100 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 650CE 250/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 680CE 250/125 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 690CE 300/75 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 690CE 300/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 700CE 300/100 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 700CE 300/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 LE 720CE 300/125 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 locomotion 190/65 DE med treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 locomotion® 150/50 DE med treadmill h/p/cosmos 150/50 (locomotion) 93/42 locomotion® 190/65 3p DE med treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p) 93/42 locomotion® 190/65 3p E med treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p) 93/42 locomotion® 190/65 E med treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 mercury® med OEM treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 mercury® med treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 mercury® med treadmill h/p/cosmos 150/50 G7 (pluto, mercury) 3 refs pluto med treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 pluto® ef med treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 pluto® lt med OEM treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 pluto® lt med treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 pluto® med OEM treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 pulsar lt med treadmill h/p/cosmos 170-190/65 MCU6 3 refs pulsar lt treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 pulsar® lt 3p treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p) 93/42 quasar lt med treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 quasar med treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 quasar® med 3p treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p) 93/42 saturn® 250/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 250/100r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 250/125r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 250/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 250/75r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 300/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 300/100r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 300/125r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 300/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 saturn® 300/75r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 stellar med treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 stellar® lt med treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 stratos® med treadmill h/p/cosmos 150/50 (pluto, mercury) 93/42 torqualizer® 1200 med 2 refs treadmill h/p/cosmos 150/50 (pluto, mercury) 13 refs 93/42 treadmill h/p/cosmos 170-190/65 (quasar, pulsar) 93/42 treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p) 93/42 venus® 200/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 venus® 200/100r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 venus® 200/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42 venus® 200/75r treadmill h/p/cosmos 200-300/75-125 (venus, saturn) 93/42
IIa, IIb
MDR, 93/42
Website
regulatory.affairs@hpcosmos.com
EUDAMED record
Report an error
Modemedikal
Türkiye
57 others BROKEN SCREW DRILL BIT-L 93/42 BROKEN SCREW DRILL BIT-S 93/42 COUNTER DRILL BIT Ø3,3 93/42 COUNTER DRILL BIT Ø3,7 93/42 COUNTER DRILL BIT Ø4,1 93/42 COUNTER DRILL BIT Ø4,7 93/42 FINAL DRILL BIT Ø2,4 93/42 FLAT DRILL BIT Ø3,7 93/42 FLAT DRILL BIT Ø4,1 93/42 FLAT DRILL BIT Ø4,7 93/42 LANCE DRILL BIT 93/42 LEVEL BONE TAP Ø3,3 93/42 LEVEL BONE TAP Ø3,7 93/42 LEVEL BONE TAP Ø4,1 93/42 LEVEL BONE TAP Ø4,7 93/42 LEVEL BONE TAP Ø5,3 93/42 LONG DRILL BIT Ø3,7 93/42 LONG DRILL BIT Ø4,1 93/42 LONG DRILL BIT Ø4,7 93/42 LONG IMPLANT DRILL BIT Ø3,7 93/42 LONG IMPLANT DRILL BIT Ø4,1 93/42 LONG IMPLANT DRILL BIT Ø4,7 93/42 LONG IMPLANT DRILL BIT Ø5,3 93/42 LONG IMPLANT DRILL BIT Ø6,0 93/42 PILOT DRILL BIT Ø 2,0 mm 10 mm 93/42 PILOT DRILL BIT Ø 2,0 mm 11,5 mm 93/42 PILOT DRILL BIT Ø 2,0 mm 13 mm 93/42 PILOT DRILL BIT Ø1,5 93/42 PILOT DRILL BIT Ø1,8 93/42 PILOT DRILL BIT Ø2,0 mm 6 mm 93/42 PROFILE DRILL BIT Ø3,3 93/42 PROFILE DRILL BIT Ø3,7 93/42 PROFILE DRILL BIT Ø4,1 93/42 PROFILE DRILL BIT Ø5,3 93/42 PROFILE DRILL BIT Ø6,0 93/42 PROVO BONE TAP Ø3 93/42 PROVO BONE TAP Ø3,5 93/42 PROVO BONE TAP Ø4 93/42 PROVO BONE TAP Ø4,5 93/42 PROVO DRILL BIT Ø1,5 93/42 PROVO DRILL BIT Ø3 93/42 PROVO DRILL BIT Ø3,5 93/42 PROVO DRILL BIT Ø4 93/42 RAPID BONE TAP Ø3,3 93/42 RAPID BONE TAP Ø3,7 93/42 RAPID BONE TAP Ø4,1 93/42 RAPID BONE TAP Ø5,3 93/42 ROUND DRILL BIT 93/42 SHORT DRILL BIT Ø3,3 93/42 SHORT DRILL BIT Ø3,7 93/42 SHORT DRILL BIT Ø4,1 93/42 SHORT IMPLANT DRILL BIT Ø3,3 93/42 SHORT IMPLANT DRILL BIT Ø3,7 93/42 SHORT IMPLANT DRILL BIT Ø4,1 93/42 SHORT IMPLANT DRILL BIT Ø4,7 93/42 SHORT IMPLANT DRILL BIT Ø5,3 93/42 SHORT IMPLANT DRILL BIT Ø6,0 93/42
IIa
93/42
Website
EUDAMED record
Report an error
BMED
Italy
55 others BONTEMPI - AA-200 - LAMA INOX LARINGOSCOPIO MILLER FIG.0 93/42 BONTEMPI - AA-201 - LAMA INOX LARINGOSCOPIO MILLER FIG.1 93/42 BONTEMPI - AA-202 - LAMA INOX LARINGOSCOPIO MILLER FIG.2 93/42 BONTEMPI - AA-203 - LAMA INOX LARINGOSCOPIO MILLER FIG.3 93/42 BONTEMPI - AA-204 - LAMA INOX LARINGOSCOPIO MILLER FIG.4 93/42 BONTEMPI - AA-250 - LAMA A FIBRE OTTICHE PER LAR.MILLER FIG.0 LARINGOSCOPI 93/42 BONTEMPI - AA-251 - LAMA A FIBRE OTTICHE PER LAR.MILLER FIG.1 LARINGOSCOPI 93/42 BONTEMPI - AA-252 - LAMA A FIBRE OTTICHE PER LAR.MILLER FIG.2 LARINGOSCOPI 93/42 BONTEMPI - AA-253 - LAMA A FIBRE OTTICHE PER LAR.MILLER FIG.3 LARINGOSCOPI 93/42 BONTEMPI - AA-254 - LAMA A FIBRE OTTICHE PER LAR.MILLER FIG.4 LARINGOSCOPI 93/42 BONTEMPI - AA-401 - LAMA PER LARINGOSCOPIO NEGUS#NOME? 93/42 BONTEMPI - AA-402 - LAMA PER LARINGOSCOPIO NEGUS#NOME? 93/42 BONTEMPI - AA-403 - LAMA PER LARINGOSCOPIO NEGUS#NOME? 93/42 BONTEMPI - AA-404 - LAMA PER LARINGOSCOPIO NEGUS#NOME? 93/42 BONTEMPI - AA-500 - LAMA A FIBRE OTTICHE PER LAR.MCINTOSH FIG.0 LARINGOSCOPI 93/42 BONTEMPI - AA-501 - LAMA A FIBRE OTTICHE PER LAR.MCINTOSH FIG.1 LARINGOSCOPI 93/42 BONTEMPI - AA-502 - LAMA A FIBRE OTTICHE PER LAR.MCINTOSH FIG.2 LARINGOSCOPI 93/42 BONTEMPI - AA-503 - LAMA A FIBRE OTTICHE PER LAR.MCINTOSH FIG.3 LARINGOSCOPI 93/42 BONTEMPI - AA-504 - LAMA A FIBRE OTTICHE PER LAR.MCINTOSH FIG.4 LARINGOSCOPI 93/42 BONTEMPI - AA-70 - MANICO INOX PER LARINGOSCOPI Ø mm.30 93/42 BONTEMPI - AA-80 - MANICO INOX PER LARINGOSCOPI Ø mm.18 93/42 BONTEMPI - AA-90H - MANICO A FIBRE OTTICHE PER LARING.Ø mm.30 LARINGOSCOPI 93/42 BONTEMPI - AA-S103 - SET LARINGOSCOPIO MCINTOSH CON 3 LAME 93/42 BONTEMPI - AA-S104 - SET LARINGOSCOPIO MCINTOSH CON 4 LAME 93/42 BONTEMPI - AA-S105 - SET LARINGOSCOPIO MCINTOSH CON 5 LAME 93/42 BONTEMPI - AA-S203 - SET LARINGOSCOPIO MILLER CON 3 LAME 93/42 BONTEMPI - AA-S204 - SET LARINGOSCOPIO MILLER CON 4 LAME 93/42 BONTEMPI - AA-S205 - SET LARINGOSCOPIO MILLER CON 5 LAME 93/42 BONTEMPI - AA-S253 - SET LARINGOSCOPIO MILLER FIBRE OTTICHE CON 3 LAME 93/42 BONTEMPI - AA-S254 - SET LARINGOSCOPIO MILLER FIBRE OTTICHE CON 4 LAME 93/42 BONTEMPI - AA-S255 - SET LARINGOSCOPIO MILLER FIBRE OTTICHE CON 5 LAME 93/42 BONTEMPI - AA-S403 - SET LARINGOSCOPIO NEGUS-GUEDEL CON 3 LAME 93/42 BONTEMPI - AA-S404 - SET LARINGOSCOPIO NEGUS-GUEDEL CON 4 LAME 93/42 BONTEMPI - AA-S503 - SET LARINGOSCOPIO MCINTOSH FIB.OTT.CON 3 LAME 93/42 BONTEMPI - AA-S504 - SET LARINGOSCOPIO MCINTOSH FIB.OTT.CON 4 LAME 93/42 BONTEMPI - AA-S505 - SET LARINGOSCOPIO MCINTOSH FIB.OTT.CON 5 LAME 93/42 BONTEMPI - AB-32 - OTOSCOPIO CON 3 SPECULUM E ASTUCCIO OFTALMOSCOPI 93/42 BONTEMPI - AB-34 - OFTALMOSCOPIO STANDARD 93/42 BONTEMPI - AB-48 - OTO-OFTALMO ALOGENO PER VETERINARIA OFTALMOSCOPI 93/42 BONTEMPI - AB-49 - OTOSCOPIO A LUCE ALOGENA COMPLETO OFTALMOSCOPI 93/42 BONTEMPI - AT-1 - ABLATORE DEL TARTARO SINGOLO DIRITTO CUCCHIAI E CURETTE 93/42 BONTEMPI - AT-12 - SCALER MITCHEL FIG.2 cm.17 CUCCHIAI E CURETTE 93/42 BONTEMPI - AT-2L - ABLATORE DEL TARTARO SINGOLO SINISTRO CUCCHIAI E CURETTE 93/42 BONTEMPI - AT-2R - ABLATORE DEL TARTARO SINGOLO DESTRO CUCCHIAI E CURETTE 93/42 BONTEMPI - AT-6 - ABLATORE DEL TARTARO DOPPIO 2RL-DX-SX CUCCHIAI E CURETTE 93/42 BONTEMPI - FR-20 - TRAPANO HUDSON A MANO - COMPLETO PERFORATORI 93/42 BONTEMPI - FR-21 - TRAPANO HUDSON A MANO SOLO PERFORATORI 93/42 BONTEMPI - PC-01 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO, CONF. 5PZ, 20 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-02 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO ANG., CONF. 5PZ, 20 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-03 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO, 35 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-04 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO ANG., 35 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-05 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO, 70 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-06 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO ANG., 70 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-07 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO, 105 mm BISTURI E COLTELLI 93/42 BONTEMPI - PC-08 - ELETTRODI MONOPOLARI AD AGO DI TUNGSTENO ANG., 105 mm BISTURI E COLTELLI 93/42
I
93/42
Website
EUDAMED record
Report an error
Fudakang FDA
EU representative : MedPath GmbH (Germany)
China
55 others
IIa
93/42
Website
EUDAMED record
Report an error
Neitz FDA
EU representative : MDSS GmbH (Germany)
Japan
52 others
I
MDR
Website
EUDAMED record
Report an error
Quality In Flow FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Israel
52 others
IIa, IIb
93/42
info@qinflow.com
EUDAMED record
Report an error
Gyrus ACMI FDA
EU representative : Olympus Europa SE & Co. KG (Germany)
United States
51 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Termosalud FDA
Spain
51 others
IIa, IIb
MDR, 93/42
regulatory@termosalud.com
EUDAMED record
Report an error
Edan FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
50 others
I, IIa, IIb
MDR
EUDAMED record
Report an error
MED-Fibers FDA
EU representative : Total-Laser Solution GmbH (Austria)
United States
50 others MED-Fibers, Inc. MF 400/440 RM 93/42 MED-Fibers, Inc. MF 800/880 SBT 2mmCB 2 refs 93/42 MED-Fibers, Inc. MF ENT 200 N 93/42 MED-Fibers, Inc. MF-1000/1100-HCBT 93/42 MED-Fibers, Inc. MF-150/180-HHz 93/42 MED-Fibers, Inc. MF-200-SBT 93/42 MED-Fibers, Inc. MF-200-SBT-BT 93/42 MED-Fibers, Inc. MF-272/300-A 93/42 MED-Fibers, Inc. MF-272/300-HHz 93/42 MED-Fibers, Inc. MF-272/300-HHz-DT 93/42 MED-Fibers, Inc. MF-272/300-SBT 93/42 MED-Fibers, Inc. MF-272/300-SBT-DT 93/42 MED-Fibers, Inc. MF-365/400-A 93/42 MED-Fibers, Inc. MF-365/400-HHz 93/42 MED-Fibers, Inc. MF-365/400-SBT 93/42 MED-Fibers, Inc. MF-400-HPCS-ES 93/42 MED-Fibers, Inc. MF-400-HPCS-ES 5 pack 93/42 MED-Fibers, Inc. MF-400/440-CON 93/42 MED-Fibers, Inc. MF-400/440-CON-TB 93/42 MED-Fibers, Inc. MF-400/440-R 5 meter 93/42 MED-Fibers, Inc. MF-400/440-RM-5pack 93/42 MED-Fibers, Inc. MF-400/440-RM-TB 93/42 MED-Fibers, Inc. MF-550/600-HCBT 93/42 MED-Fibers, Inc. MF-550/600-HHz 93/42 MED-Fibers, Inc. MF-600-HPCS-ES 5 pack 93/42 MED-Fibers, Inc. MF-600/630-CON 93/42 MED-Fibers, Inc. MF-600/630-CON-TB 93/42 MED-Fibers, Inc. MF-600/630-R 5 meter 93/42 MED-Fibers, Inc. MF-600/630-RM 93/42 MED-Fibers, Inc. MF-600/630-RM-5pack 93/42 MED-Fibers, Inc. MF-ENT-300-BEND 93/42 MED-Fibers, Inc. MF-Tuohy Borst Adapters (FLOW30, Male Spin/Lock, Pediatric) 93/42 MED-Fibers, Inc. MF-Tuohy Borst Adapters (FLOW30, Male Spin/Lock, Pediatric) 25 Pack 93/42 MED-Fibers, Inc. TXMF400R 93/42 MED-Fibers, Inc. TXMF400RZ 93/42 MED-Fibers, Inc. TXMF600BFS 93/42 MED-Fibers, Inc. TXMF600R 93/42 MF 200 Series 3 refs 93/42 MF 300 Series 2 refs 93/42 MF 600 Series 2 refs 93/42 MF 800 Series MF 800/880 Series 93/42 MFR1000 Series MFR 1000 Series 93/42 MFR272/300A MFR 272 Series 93/42 Surgical Fiber Optic Assembly 93/42 Surgical Fiber Optic Assembly MF 200/240 SBT EF 93/42 Surgical Fiber Optic Assembly MF 600/660 SBT 93/42 Surgical Fiber Optic Assembly MF 600/750 HPCS 93/42 Surgical Fiber Optic Assembly MF 800/880 SBT CB 93/42 Surgical Fiber Optic Assembly MF ENT 200 N 93/42 Surgical Fiber OPtic Assembly MFR 600 HPC ES 93/42
IIb
93/42
Website
info@med-fibers.com
EUDAMED record
Report an error
Natus FDA
EU representative : Natus Manufacturing Ltd (Ireland)
Canada, Denmark, United States
48 others
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Beurer
Germany
45 others
I, IIa
MDR, 93/42
info@beurer.de
EUDAMED record
Report an error
Bioner
Spain
45 others
IIa
93/42
Website
EUDAMED record
Report an error
Evidence Implant FDA
EU representative : Meridius Medical Europe Limited (Ireland)
South Korea
45 others
IIa
93/42
Website
EUDAMED record
Report an error
Inomed FDA
Germany
45 others C3 CryoSonde 2.1 mm spitz für C3 CryoSystem 217200 93/42 C3 CryoSystem 217000 93/42 Einmalkanüle 12Gx62 mit Mandrin 217660 93/42 Einmalkanüle 12Gx92 mit Mandrin 217680 93/42 Einmalkanüle 15Gx45 mit Mandrin 217604 93/42 Einmalkanüle 15Gx65 mit Mandrin 217606 93/42 Einmalkanüle 15Gx95 mit Mandrin 217609 93/42 Führungsrohr für RF TC Brain Electrode 260595 93/42 ISIS Headbox 16 Ch. DIF 504271 93/42 ISIS Headbox 16Ch. REF - AEP 504281 93/42 ISIS Headbox 16Ch. REF 504261 93/42 ISIS Headbox 8Ch. DIF - 8Ch. REF - AEP 504285 93/42 ISIS Headbox U8DRD 504270 93/42 ISIS Headbox U8DTP 504275 93/42 ISIS Headbox U8SRD 504260 93/42 ISIS Headbox U8SRD-AEP 504280 93/42 ISIS Headbox U8STP-AEP 504265 93/42 ISIS MER System Kompakt Komplettsystem 590102 3 refs ISIS Neurostimulator 504180 93/42 ISIS Neurostimulator Komplettsystem 504185 ISIS System Base Unit 504000 ISIS Xpert Plus System 504004 2 refs ISIS Xpress System für individuelle Konfiguration 504006 LG1, RF-Läsionsgenerator, 1 Kanal Stimulation, Kont. und Gepulste RF 261000 93/42 LG2, RF-Läsionsgenerator, 2 Kanal Stimulation, Kont. und Gepulste RF 262000 93/42 LG2-sEEG, RF-Läsionsgenerator 1 Kanal TC und 1 Kanal sEEG 263000 93/42 RF TC Brain Electrode 1x1,5 asymetrisch,Typ:TCBA 011 260511 93/42 RF TC Brain Electrode bipolar 1x1,5mm, Typ:TCB012 260512 93/42 RF TC Brain Electrode bipolar 1x2,0mm, Typ:TCB012 260404 93/42 RF TC Brain Electrode bipolar 2x2mm, Typ:TCB013 260513 93/42 RF TC Brain Electrode monopolar 1x1,5mm, Typ:TCU001 260501 93/42 RF TC Brain Electrode monopolar 1x3mm,Typ:TCU002 260502 93/42 RF TC Brain Electrode monopolar 2x4mm,Typ:TCU003 260503 93/42 SUSy Stereotaxiesystem für Keramikring 808000 2 refs TC-Schmerz-Elektrode 100mm mit 7-pol. Lemosa-Kupplung 260010 93/42 TC-Schmerz-Elektrode 100mm mit inomed SuperLight-Stecker 260011 93/42 TC-Schmerz-Elektrode 150mm mit 7-pol. Lemosa-Kupplung 260015 93/42 TC-Schmerz-Elektrode 150mm mit SuperLight-Stecker 260016 93/42 TC-Schmerz-Elektrode 50mm mit 7-pol. Lemosa-Kupplung 260005 93/42 TC-Schmerz-Elektrode 50mm mit inomed SuperLight-Stecker 260006 93/42 TC-Trigeminus-Elektrode mit 7-pol. Lemosa-Kupplung 260126 93/42 TC-Trigeminus-Elektrode mit inomed SuperLight-Stecker 260121 93/42 Thermosonde für Kombi-Elektrode. Art.230777 260561 93/42 ZD Befestigungsschiene für offenen Ring 802010 2 refs Äußeres Führungsrohr für RF TC Brain Electrode 260590 93/42
I, IIa, IIb, III
MDR, 93/42
Website
info@inomed.com
EUDAMED record
Report an error
Turkuaz Biyomedikal Tekn Ve Sag Hizm San Tic Sti
Türkiye
45 others
IIb
93/42
Website
info@tbtmedical.com
EUDAMED record
Report an error
Zhejiang Haisheng Medical Device FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
45 others
IIb
MDR, 93/42
EUDAMED record
Report an error
BTL Industries FDA
EU representative : BTL ITALIA S.r.l. (Italy)
United Kingdom (ex Northern Ireland)
44 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Nüve Sanayi̇ Malzemeleri̇ İmalat Ve Ti̇caret Anoni̇m Şi̇rketi̇
Türkiye
44 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Medcaptain FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
43 others EP-90, EP-90T, EP-90 Ex, EP-90 PRO 3 refs HP TCI 93/42 HP TCI PRO 93/42 HP-30, HP-30 Neo, HP-30 PRO, S700, S720 PCA HP-60, HP-60C, HP-60 PRO, HP-60C PRO, V700 HP-80 93/42 HP-80 MRI 93/42 HP-80 PRO 93/42 iCMS,BD neXus Medication Safeware MP-30 93/42 MP-30A 93/42 MP-30T 93/42 MP-60 93/42 MP-60A 93/42 MP-60C 93/42 MP-60T 93/42 MP-80 93/42 MP-80A 93/42 MP-80T 93/42 MRI 700 93/42 MS-100 93/42 S740 TCI 93/42 SYS-50 93/42 SYS-52 93/42 SYS-56 93/42 SYS-58 93/42 SYS-6010 93/42 SYS-6010A 93/42 SYS-6010T 93/42 SYS-70 93/42 TP-100,TP-200,TP-300,TP-600 TP-20 93/42 TP-20S 93/42 U7, U7 PRO, U7 EX, U7 SE, U7D, U7L, U7T, U7Q, U5, U5 PRO, U5 EX, U5 SE, U5D, U5L, U5T, U5Q UC-500I,UC-500L,UC-500TI,UC-500TL,UC-500XTI,UC-500XTL,UC-700I,UC-700L,UC-700RI,UC-700RL,UC-700TI,UC-700TL,UC-700XTI,UC-700XTL,UC-500DTI,UC-500DTL,UC-700DTI,UC-700DTL,UC-E500DTI,UC-E700DTI,UC-500ZTI,UC-500ZTL,UC-700ZTI,UC-700ZTL,UC-E500ZTI,UC-E700ZTI UG-500, UG-500T, UG-700, UG-700T, UG-500D, UG-700D, UG-E500D, UG-E700D, UG-500Z, UG-700Z, UG-E500Z, UG-E700Z VC-10, VC-10A, VC-10T, VC-10 PRO VC-20, VC-20A, VC-20T, VC-20 PRO VC-30, VC-30A, VC-30T, VC-30 PRO VS-10S, VS-10M, VS-10H XP-30, XP-30 PRO, AP-30, AP-30 PRO XP-60, XP-60 PRO, XP-60C, XP-60C PRO, XP-60T, AP-60, AP-60 PRO, AP-60C, AP-60C PRO, AP-60T XP-80, XP-80 PRO, AP-80, AP-80 PRO
I, IIa, IIb
MDR, 93/42
Website
info@medcaptain.com
EUDAMED record
Report an error
Emd
Hungary
42 others Craniotome head, L15, Rotatable MultiSmart 93/42 Craniotome head, L25, Fix MultiSmart 93/42 Craniotome head, L25, Rotatable MultiSmart 93/42 Curved Slim head, L105 MultiSmart 93/42 Curved Slim head, L125 MultiSmart 93/42 Curved Slim head, L85 MultiSmart 93/42 Fluid bottle holder for NSS-110 MultiSmart 93/42 Footswitch MultiSmart 93/42 Handpiece head MultiSmart 93/42 High-speed motor MultiSmart 93/42 Instrument tray MultiSmart 93/42 Laminotome head, L35, Fix MultiSmart 93/42 Laminotome head, L35, Rotatable MultiSmart 93/42 Linear Slim head, L105 MultiSmart 93/42 Linear Slim head, L125 MultiSmart 93/42 Linear Slim head, L85 MultiSmart 93/42 Oil spray nozzle MultiSmart 93/42 Oiling spray MultiSmart 93/42 Perforator handpiece MultiSmart 93/42 Rinse-wash device MultiSmart 93/42 Slim handpiece, Angled MultiSmart 93/42 Standard handpiece, L120 A, Angled MultiSmart 93/42 Standard handpiece, L120 S, Straight MultiSmart 93/42 Standard handpiece, L170 A, Angled MultiSmart 93/42 Standard handpiece, L170 S, Straight MultiSmart 93/42 Standard handpiece, L220 A, Angled MultiSmart 93/42 Standard handpiece, L220 S, Straight MultiSmart 93/42 Standard handpiece, L25 A, Angled MultiSmart 93/42 Standard handpiece, L25 S, Straight MultiSmart 93/42 Standard handpiece, L45 A, Angled MultiSmart 93/42 Standard handpiece, L45 S, Straight MultiSmart 93/42 Standard handpiece, L70 A, Angled MultiSmart 93/42 Standard handpiece, L70 S, Straight MultiSmart 93/42 Standard handpiece, L95 A, Angled MultiSmart 93/42 Standard handpiece, L95 S, Straight MultiSmart 93/42 Standard irrigation adapter, L120 MultiSmart 93/42 Standard irrigation adapter, L170 MultiSmart 93/42 Standard irrigation adapter, L220 MultiSmart 93/42 Standard irrigation adapter, L25 MultiSmart 93/42 Standard irrigation adapter, L45 MultiSmart 93/42 Standard irrigation adapter, L70 MultiSmart 93/42 Standard irrigation adapter, L95 MultiSmart 93/42
IIb
93/42
Website
EUDAMED record
Report an error
Longlife FDA
EU representative : MDSS GmbH (Germany)
Pakistan
42 others Child, 2 AL-1212 3 refs Child, 2 AL-1215 3 refs Child, 2 AL-1401 3 refs Child, 2 AL-1402 3 refs Child, 2 AL-1404 3 refs Child, 2 AL-1405 3 refs Child, 2 AL-1406 3 refs Child, 2 AL-1408 3 refs Child, 2 AL-1424 3 refs Child, 2 AL-1426 3 refs Child, 2 AL-1427 3 refs Child- 2 AL-1403 3 refs Extra Medium Adult 3.5 AL-1411 3 refs Halogen Lamp 2.5V Replacement Lamp 3 refs Infant AL-1651 3 refs Infant AL-1852 3 refs Infant AL-1858 3 refs Infant AL-1859 3 refs Infant, (1xLithium 123 Size) AL-1251 3 refs Infant, (1xLithium 123 Size) AL-1451 3 refs Infant, 1 AL-1209 3 refs Infant, 1 AL-1210 2 refs Infant, 1 AL-1216 Infant, 1 AL-1410 3 refs Infant, 1 AL-1416 Infant. AL-1652 3 refs Light Guide for Macintosh Blade 0 AL-1461 3 refs Mac Blade 0 with Battery Handle Med AL-1854 3 refs Mac Blade 0 with Battery Handle Med AL-1856 3 refs Mac Conventional Laryngoscope Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1213 3 refs Mac F.O LED Laryngoscope Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1420 3 refs Miller Blade 0 with Battery Handle Med AL-1853 3 refs Miller Blade 0 with Battery Handle Med AL-1855 3 refs Miller Conventional Laryngoscope Sets Set of 5 Blades 0,1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1214 3 refs Miller F.O LED Laryngoscope Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1421 3 refs Neonate 0 AL-1409 2 refs Neonate, 0 AL-1413 2 refs Replacement LED capsule For Handle AL-1857 Set of 2 Blades 3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1418 Set of 2 Blades 3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1422 Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1417 3 refs Set of 4 Blades 1,2,3,4 with 1 Med Handle, 1 Replacement Lamp, in Plastic Case AL-1415 3 refs
I
MDR
Website
EUDAMED record
Report an error
IDS FDA
EU representative : Obelis s.a. (Belgium)
South Korea
41 others
IIb
93/42
Website
EUDAMED record
Report an error
Zhejiang UE Medical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
EBS-380C, EBS-500C, EBS-600C, EBS-380K, EBS-500K, EBS-600K 3 refs Flexible Videoscopes EBM-120P1R, EBM-120P2R, EBM-120P3R, EBM-120MR, EBM-120LR, EBM-120T1MR, EBM-120T1LR, EBM-120T2MR, EBM-120T2LR, EBM-120T3R 3 refs Flexible Videoscopes ENF-120P1, ENF-120P2, ENF-120, ENF-120T 3 refs Flexible Videoscopes TIC-I0,TIC-I1,TIC-I2,TIC-I3,TIC-I4,TIC-I5,PL-F260,PL-F320,PL-F400,PL-F520,PL-SF280,PL-SF380,PL-SF420,PL-SF480,PL-SF520 3 refs PL-F260 93/42 40 others PL-F320 93/42 PL-F400 93/42 PL-F520 93/42 TD-C-III 93/42 TD-C-III-3 93/42 TD-C-IV 93/42 TD-C-IV-3 93/42 TD-C-V 93/42 TD-C-V-3 93/42 TDC-C2 93/42 TDC-C2-3 93/42 TDC-C3 2 refs 93/42 TDC-C3-3 93/42 TDC-C4 2 refs 93/42 TDC-C4-3 93/42 TDC-K2 93/42 TDC-K2-3 93/42 TDC-K3 2 refs 93/42 TDC-K3-3 93/42 TDC-K4 2 refs 93/42 TDC-K4-3 93/42 TIC-I0（TIC-SD-I) 93/42 TIC-I1 93/42 TIC-I2(TIC-SD-II) 93/42 TIC-I3 93/42 TIC-I4 93/42 TIC-I5(TIC-SD-III) 93/42 UE Display UE-M10S Pro, UE-M10S Plus 2 refs UE Display UED-M3, UED-M3-S 2 refs UE Display VPM-T30-01 UE Display VPM-T35 UE-M10S 2 refs UE-M8-S Video Laryngoscope for Single Use UED-D Series 3 refs Video Laryngoscope for Tracheal Intubation UED-A0, UED-A3, UET-A0, UET-A3 3 refs Video Laryngoscope for Tracheal Intubation UED-C0,UED-C1,UED-MC1,UED-C2,UED-C3,UED-C4,UET-C0,UET-C1,UET-MC1,UET-C2,UET-C3,UET-C4 3 refs Video Laryngoscope VLS2-01,VLS2-02 2 refs Video Nasoscope VNS1-01 Video Otoscope VOS1-01, VOS1-02 2 refs VP-180, VP-180D, VP-180S, VP-180P, VP-180M 3 refs
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Rossmax FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Switzerland, Taiwan
39 others
I, IIa, IIb
MDR, 93/42
Website
info@rossmax.com
EUDAMED record
Report an error
Tonica Elektronik A S FDA
Denmark
39 others
IIa
93/42
regulatory@magventure.com
EUDAMED record
Report an error
Ajmedical
Sweden
37 others
I
MDR
Website
info@ajmedical.se
EUDAMED record
Report an error
Azwanind
EU representative : Yellow's medical instruments GmbH (Germany)
Pakistan
37 others
I
MDR
Website
EUDAMED record
Report an error
Medtronic FDA
EU representative : Medtronic B.V. (Netherlands)
United States
37 others
I, IIa, IIb, III
MDR, 93/42
EUDAMED record
Report an error
ASA FDA
Italy
40 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Biolase FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
35 others
IIb
93/42
Website
ra@biolase.com
EUDAMED record
Report an error
Wh FDA
Austria, Italy
35 others
I, IIa, IIb
MDR, 93/42
Website
office.sterilization@wh.com
EUDAMED record
Report an error
Zethon FDA
EU representative : De Soutter Medical Limited (Netherlands)
United Kingdom (ex Northern Ireland)
35 others
I, IIa, III
MDR, 93/42
regulatory@zethon.com
EUDAMED record
Report an error
Modül Grup Mühendislik Elektr Med İnş Eğt Ve Bilş San Tic Şti
Türkiye
34 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
D.O.R.C. Dutch Ophthalmic Research Center (International) FDA
Netherlands
33 others 27G Two Dimensional Cutter – 20k CPM 93/42 27G Ultra Short Disposable 8000 CPM TDC cutter 93/42 Disposable High Speed Cutter 20G/8000CPM 93/42 Disposable High Speed Cutter 23G/8000CPM 93/42 Disposable High Speed Cutter 25G/8000CPM 93/42 Disposable High Speed TDC Cutter 23 G / 6000 CPM DORC Continuum range 93/42 Disposable High Speed TDC Cutter 23 G / 8000 CPM DORC Continuum range 93/42 Disposable High Speed TDC Cutter 25 G / 6000 CPM DORC Continuum range 93/42 Disposable High Speed TDC Cutter 25 G / 8000 CPM DORC Continuum range 93/42 Disposable High Speed TDC Cutter 27 G / 6000 CPM DORC Continuum range 93/42 Disposable High Speed TDC Cutter 27 G / 8000 CPM DORC Continuum range 93/42 Disposable Pneumatic Vitrectome (20 gauge / 0.9 mm) (working with 42 P.S.I., max. 6000 cuts/min) 93/42 Disposable Pneumatic Vitrectome (23 gauge / 0.6 mm) (working with 42 P.S.I., max. 6000 cuts/min) 93/42 Disposable Pneumatic Vitrectome (25 gauge / 0.5 mm) (working with 42 P.S.I., max. 6000 cuts/min) 93/42 Disposable reversed Sinskey hook with irrigation 93/42 EVA NEXUS, Phaco emulsification NCBF system 93/42 EVA NEXUS, Phaco emulsification system 93/42 EVA NEXUS, Phaco vitrectomy NCBF system 93/42 EVA NEXUS, Phaco vitrectomy NCBF system including laser with DORC connector 93/42 EVA NEXUS, Phaco vitrectomy NCBF system including laser with SMA connector 93/42 EVA NEXUS, Phaco vitrectomy system 93/42 EVA NEXUS, Phaco vitrectomy system including laser with DORC connector 93/42 EVA NEXUS, Phaco vitrectomy system including laser with SMA connector 93/42 EVA, anterior machine 93/42 EVA, anterior machine NCBF 93/42 EVA, combined machine 93/42 EVA, combined machine including Laser (DORC connector) 93/42 EVA, combined machine including Laser (SMA connector) 93/42 EVA, combined machine including Laser (SMA connector) with conventional Foot Pedals 93/42 EVA, combined machine NCBF 93/42 EVA, combined machine NCBF including Laser (DORC connector) 93/42 EVA, combined machine NCBF including Laser (SMA connector) 93/42 EVA, combined machine with conventional Foot Pedal 93/42
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Emsaş A.Ş
Türkiye
33 others
I, IIa, III
MDR, 93/42
Website
EUDAMED record
Report an error
Erbe Elektromedizin FDA
Germany
33 others
IIa, IIb
MDR, 93/42
Website
Ralf.Mack@erbegroup.com
EUDAMED record
Report an error
Meden
Poland
33 others AXELERO I Cardio BALMED ECO BALMED ECO AIR BATHAID ECONOMY CHIROSPACE E2.C4-H SAFARI BUFFALO, SAFARI ELEPHANT EKOPOMPA I ELEPHANT B-S1.F4 B-S1.F0, B-S1.F4, B-S2.F0, B-S2.F4, B-S1.F4-H, B-S2.F0-H, B-S2.F4-H, B-S2.F4-H ELEVEO FIRE S3.F0 TERAPEUTA, MONTANE, PRESTIGE, Z-ULTIMATE, ELEMENTAL GALAXY TRACTION T3.F0 T3.F0 XL Hoptop InVacMed JZM Panel 2000 H,N,P,K LEOPARD S3.F0 Z-ADVANCED, NEXUS, SAFARI, FLOW, MATERA, GALAXY LZM 3 LZM 1, 2, 3, Colombia MARS / WENUS MEDCART, WINBACK, QUBIC MERCURY S4.F0-H NEXUS, SAFARI, GALAXY, Z-ADVANCED NBC1 ORKAN NPL2 BRYZA OKO PACIFIC FIJI E5, P5, P7; PACIFIC HAWAII S2,S4,E2 PIO SAFARI ELEPHANT B-S1.F0-H SAFARI ELEPHANT B140-S1.2F2 SOLMED DUO SOLMED UNO, DUO, TRIO TERAPEUTA E-S2.F0, E-S2.F4 TRITON 6E TRITON 6M, 6E UCS VERTIMO CLASSIC, HI-LO UNO, HI-LO DUO, HI-LO DUO+ WaveMOTION ELLIPSE S1,S2,S4 WKD, WKS, WKD, WKR
I, IIa, IIb
MDR
Website
eudamed@meden.com.pl
EUDAMED record
Report an error
Schiller FDA
EU representative : SCHILLER Medizintechnik GmbH (Germany)
France, Switzerland
33 others
I, IIa, IIb
MDR, 93/42
Website
info@schiller.ch
EUDAMED record
Report an error
Medexim
Slovakia
32 others
IIa
93/42
Website
EUDAMED record
Report an error
Meditech FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China, Hungary
32 others
IIa, IIb
93/42
Website
sales@meditech.cn
EUDAMED record
Report an error
Otodynamics FDA
EU representative : MDSS GmbH (Germany)
United Kingdom (ex Northern Ireland)
32 others
I, IIa
MDR, 93/42
Website
support@otodynamics.com
EUDAMED record
Report an error
Redcord
Norway
32 others Redcord Ceiling Suspension, 26-87cm Redcord Ceiling Suspension, Axis/Mini Redcord Ceiling Suspension, Mini Redcord Ceiling Suspension, Trainer standard Redcord Doorfix, one pair Redcord Elastic cord 30cm, black Redcord Elastic cord 30cm, red Redcord Elastic cord 60cm, black Redcord Elastic cord 60cm, red Redcord Home Gym Redcord Mat Redcord Mini Redcord Mini Extra Redcord Narrow sling Redcord Portable Gym Redcord PowerGrip, one pair Redcord Rehab Pro Redcord Rehab Pro Plus Redcord Roll Redcord Rope 30cm, one pair Redcord Rope 5m Redcord Rope 60cm, one pair Redcord Rope Set for upgrading Redcord Sliding Suspension System III Redcord Split sling Redcord Strap, one pair Redcord Tandem Station Redcord Trainer Redcord Wide sling Redcord Workstation Professional Redcord Workstation Professional, Floor stand Redcord Workstation Professional, Wall stand
I
MDR
Website
EUDAMED record
Report an error
Resvent FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
32 others
IIa, IIb
MDR, 93/42
Website
info@resvent.com
EUDAMED record
Report an error
Foshan COXO Medical Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
China
229, 229-1, 229-1B, 229-B, 229-GN, 229-GN1, 229-GW, 229-GW1, 229-GS, 229-GS1, 229-GK1, 229-GK2 3 refs C-CLEAR-1,2 C-CLEAR-1(A) ,C-CLEAR-2 4）,C-CLEAR-2(A) 3 refs C-EXPLORER 2 refs C-HUNTER C-KT ,C-GL 3 refs 31 others C-Puma 93/42 C-PUMA EX C-PUMA MASTER C-PUMA Pro C-ROOT I+,C-ROOT I(VI) 2 refs C-Sailor Air C-Sailor S2，C sailor Pro+（wired)，C sailor Pro+（wireless），C-Sailor S1 3 refs C-Sailor,C-Sailor+,C-sailor Pro 3 refs C-smart I pro C-SMART-I PILOT C-Smart-mini 2 refs C-Smart-Mini AP，C-Smart-Mini AP+ 3 refs CA-1 2 refs CX207 93/42 CX207-A 93/42 CX207-B-2 93/42 CX207-C 2 refs 93/42 CX207-C-2 93/42 CX207-F 2 refs 93/42 CX207-W 93/42 CX207，CX207-G，CX207-2，CX207-A，CX207-A-2，CX207-B，CX207-B-2，CX207-C，CX207-C-2，CX207-F， CX207-W，CX207-W-2 3 refs CX235-1B，CX235-1C，CX235-1E，CX235-1F，CX235-1G，CX235C1，CX235C2，CX235C3， CX235C4，CX235C5，CX235C6，CX235C7，CX235C8，CX235-2S，CX235-2S1 3 refs CX235-1C 93/42 CX235-3B 93/42 CX249-22,CX249-22,CX249-23,CX249-24 2 refs DB686 Swift，DB686，DB686 Nano，DB686-1b,DB686 Q1,DB686 Q2,DB686 Halo 3 refs DP-1 2,DP-2 2 refs PT Master 2 refs Rooter Universal – Contra-angle CX235C4 93/42 TP-1 Ultra smart 2 refs
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Konsung FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
31 others AURORA 8s 93/42 konsung SONOSAT-F01T 93/42 konsung SONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LP KSN-5 93/42 KSOC-10 93/42 KSOC-5 93/42 KSW-5 93/42 KSW-5,KSJ-5,KSI-5,KSQ-5 3 refs Oxygen concentrator Oxygenate 5 (KSW-5) 93/42 Oxygen concentrator Oxygenate 5（konsung：KSW-5 ） 93/42 oxygenate KSOC-10 （230V 50Hz） 93/42 Oxygenate KSW-5 93/42 oxygenate KSW-5 (220V, 50Hz, Philips） 93/42 philips KSOC-10 2 refs 93/42 SONOSAT-F01LP 93/42 SONOSAT-F01LT 93/42 SONOSAT-F01LW 93/42 SONOSAT-F01P 93/42 SONOSAT-F01W 93/42 SONOSAT-F02LP 93/42 SONOSAT-F02LT 93/42 SONOSAT-F02LW 93/42 SONOSAT-F02P 93/42 SONOSAT-F02T 93/42 SONOSAT-F02W 93/42 SONOSAT-W01LP 93/42 SONOSAT-W01LT 93/42 SONOSAT-W01LW 93/42 SONOSAT-W01P 93/42 SONOSAT-W01T 93/42 SONOSAT-W01W 93/42
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
STEMA Medizintechnik
Germany
31 others
I, IIb
MDR, 93/42
Website
info@stema-medizintechnik.de
EUDAMED record
Report an error
Wrmed FDA
EU representative : MDSS GmbH (Germany)
United States
31 others 0130 0134 0136 0138 0146 0150 0151 0152 0153 0154 0159 0161 0162 0163 0169 0174 0175 Therabath, TB10 ADJ, PeachE, 220V 93/42 Therabath, TB10 ADJ, ScentFree, 220V 93/42 Therabath, TB7, Cranberry Zest, 220V 93/42 Therabath, TB7, Blooming Lilacs, 220V 93/42 Therabath, TB7, Cucumber Thyme, 220V 93/42 Therabath, TB7, Eucalyptus Rosemary Mint 220V 93/42 Therabath, TB7, Fresh Squeezed Lemon, 220V 93/42 Therabath, TB7, Lavender Harmony, 220V 93/42 Therabath, TB7, PeachE, 220V 93/42 Therabath, TB7, ScentFree, 220V 93/42 Therabath, TB7, Vanilla Cupcake, 220V 93/42 Therabath, TB7, w/o Wax, 220V 93/42 Therabath, TB7, Warm Apple Spice, 220V 93/42 Therabath, TB7, Wintergreen, 220V 93/42
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Covidien FDA
EU representative : Medtronic B.V. (Netherlands)
United States
31 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Genadyne FDA
EU representative : Obelis s.a. (Belgium)
United States
30 others
IIa, IIb
93/42
Website
info@genadyne.com
EUDAMED record
Report an error
Hangzhou Hawk Optical Electronic Instruments FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4K UHD Camera Head HK-S600,HK-S800,HK-162S,HK-162S,HK-162H,HK-162A 3 refs 4K UHD Monitor 3 refs Adaptateur poire d'Ellik PG-VA, PG-VB,PG-VC,XPG-II, PPS-II, DS-II, SS-II, NS-II, NQ-II, XNQ-I 3 refs Blade,Φ4.5 mm x 400 mm YSB-III,YSB-IIIA 3 refs Collecteur de tissus 300 ml, avec tuyau d'aspiration (Stérile) 93/42 30 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Seesheen
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
30 others Seesheen BR-1249 93/42 Seesheen BR-1259 93/42 SEESHEEN BR-15AF、BR-15AF plus、BR-15AP、BR-15AP plus、BR-15A、BR-15A plus 3 refs SEESHEEN BR-15PF、BR-15PF plus、BR-15AT、BR-15AT plus、BR-15、BR-15 plus、BR-15T、BR-15T plus 3 refs SEESHEEN BR-E14PF、BR-E14PF plus、BR-E14PT、BR-E14PT plus、BR-E14F、BR-E14F plus、BR-E14H、BR-E14H plus、BR-E14HT、BR-E14HT plus、BR-E14HTB、BR-E14HTB plus、BR-E14TB、BR-E14TB plus 3 refs SEESHEEN BR-GP13PF、BR-GP13PF plus、BR-GP13F 、BR-GP13F plus、BR-GP13PT 、BR-GP13PT plus、BR-GP13H 、BR-GP13H plus、BR-GP13HT、BR-GP13HT plus、BR-GP13HTB、BR-GP13HTB plus、BR-GP13TB、BR-GP13TB plus 3 refs SEESHEEN BRD-15P、BRD-15PFS、BRD-15PT、BRD-15PTS、BRD-15、BRD-15S、BRD-15T、BRD-15TS 3 refs Seesheen CH-1331 93/42 Seesheen CH-1349 93/42 SEESHEEN CV-1030, CV-1080, HV-3030, HV-3101、HV-50 2 refs Seesheen CY-1355 93/42 Seesheen CY-1356 93/42 SEESHEEN EC-GP13、EC-GP13L、EC-GP13 pro、ECGP13L pro、EC-GP13B、EC-GP13BL、EC-GP13B pro、EC-GP13BLpro 3 refs SEESHEEN EG-GP13N、EG-GP13N pro、EG-GP13、EG-GP13 pro、EG-GP13T、EG-GP13T pro、EG-GP13J、EG-GP13Jpro、EG-GP13BJ、EG-GP13BJ pro 3 refs Seesheen EN-1249 93/42 SEESHEEN EN-14T, EN-14T plus, EN-14HT, EN-14HT plus 3 refs SEESHEEN EN-14X, EN-14X plus, EN-14, EN-14 plus, EN-14HX, EN-14HX plus, EN-14H, EN-14H plus 3 refs SEESHEEN EN-E19H，EN-1029，EN-1039 3 refs SEESHEEN EN-GP13HT plus、EN-GP13HT、EN-GP13T plus、EN-GP13T 3 refs SEESHEEN HP-1315、HP-1315 pro、HP-1315 pro2、HP-1315 pro3 3 refs SEESHEEN HT-1415,HT-1415 pro,HT-1415 pro2,HT-1415 pro3 3 refs Seesheen QG-2152 93/42 Seesheen QG-3032 93/42 Seesheen QG-3048 93/42 Seesheen QG-3052 93/42 Seesheen UR-1328 93/42 Seesheen UR-1331 93/42 TH-E12、TH-E12 PLUS、TH-E12H、TH-E12H PLUS 3 refs UR-332, UR-328 2 refs URD-1、URD-1S、URD-1R、URD-1SR 3 refs
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Hiskymedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
30 others Confocal Microprobe Imaging System BrightP600 Confocal Microprobe Imaging System BrightP660 Confocal Microprobe Imaging System BrightP680 Confocal Microprobe Imaging System BrightP750 Confocal Microprobe Imaging System BrightP780 Confocal Microprobe Imaging System BrightP860 Confocal Microprobe Imaging System BrightP880 Confocal Microprobe Imaging System BrightP900 Confocal Microprobe Imaging System BrightP980 Confocal Microprobe Imaging System BrightX66 FH6000 93/42 FH8000 93/42 FH9000,FH8000,FH6000 Fiber Optic Microprobe L20 Fiber Optic Microprobe L30 Fiber Optic Microprobe M10 Fiber Optic Microprobe M20 Fiber Optic Microprobe M30 Fiber Optic Microprobe S10 Fiber Optic Microprobe S15 Fiber Optic Microprobe S30 Fiber Optic Microprobe S40 FT100 93/42 FT9000 93/42 Mini560 93/42 Mini900,Mini800,Mini560,FT200,FT100 Plus5000 93/42 Plus9000,Plus5000,Plus1000 Pro9000,Pro3000,Pro1000,FT9000,FT1000 Confocal Microprobe Imaging System BrightP960 (no longer marketed)
IIa
MDR, 93/42
ra@hiskymedical.com
EUDAMED record
Report an error
Hoogland Spine Products FDA
Germany
29 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
ResMed FDA
EU representative : ResMed SAS (France)
Australia
29 others
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Conmed FDA
EU representative : Conmed Europe BV (Belgium) and 1 other
United States
28 others CONMED 53 refs COOLFLEX E9000 93/42 CYNOSURE EnVision 5 refs 93/42 ERGO 93/42 Hall 93/42 HALL MICROFREE 6 refs 93/42 HALL MICROFREE MINIDRIVER 2 refs 93/42 HALL MICROPOWER+ 5 refs 93/42 Hall® Titan™ 7 refs 93/42 Hall® Titan™ Primecut+™ 93/42 HelixAR 93/42 HYFRECATOR 2 refs 93/42 MICRO 100 5 refs 93/42 MICROCHOICE 93/42 MicroFree® Non-orthopedic, Active, Electrosurgical Generator, General purpose, System 2450 3 refs 93/42 Non-orthopedic, Active, Electrosurgical Generator, General purpose, System 5000 4 refs 93/42 Orthopedic, Active, Handpiece, Battery, Pistol-grip, All, Hall 50, Modular 2 refs 93/42 Orthopedic, Active, Handpiece, Battery, Pistol-grip, All, Hall 50, Saws 3 refs 93/42 Orthopedic, Active, Handpiece, Shaver, E9000 93/42 PlumeSafe® X5™ Non-orthopedic, Active, Smoke Evacuation Unit, PlumeSafe X5 3 refs POWERPRO 6 refs 93/42 QUICKLATCH 93/42 SURGAIRTOME TWO 93/42 TOUCH GLASS 93/42 ULTRAPOWER 93/42 VISICLEAR 2 refs
I, IIa, IIb
MDR, 93/42
Website
CustomerExperience@conmed.com
EUDAMED record
Report an error
Zerone
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
28 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Bioptimal International PTE FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
Singapore
27 others
IIa
93/42
Website
ra-bpi@bioptimalg.com
EUDAMED record
Report an error
Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
Türkiye
27 others
I, IIa, IIb
93/42
Website
info@kocmedical.com
EUDAMED record
Report an error
Codan FDA
Germany
27 others Contactboard, 1-fold - FX Zubehör / Accessory IBPM 3 refs Dampening stopcock 2 refs Filling system 3 refs Holder single, adjustable Zubehör / Accessory IBPM 3 refs Modular mounting system Zubehör / Accessory IBPM 3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , ABSS 3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , CLC 3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , NBSS 3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , SWAN Switch 3 refs Monitoring set, addition green line® - Xtrans®/DPT-6000 3 refs Monitoring set, addition green line® - Xtrans®/DPT-6000 , CLC 3 refs Monitoring set, double green line® - Xtrans® / DPT-6000 , NBSS 3 refs Monitoring set, single green line® - Xtrans®/DPT-6000 , NBSS 3 refs Monitoring set, single green line® - Xtrans®/DPT-6000 , SWAN Switch Monitoring set, single Xtrans® / DPT-6000 , NBSS 3 refs Monitoring set, single Xtrans® / DPT-6000 , SWAN Switch 3 refs Monitoring set, single Xtrans® / DPT-6000, ABSS 3 refs Monitoring set, single Xtrans®/DPT-6000 3 refs Monitoring set, single Xtrans®/DPT-6000 , CLC 3 refs Mounting plate, quadruple Zubehör / Accessory IBPM Mounting plate, Single Zubehör / Accessory IBPM 3 refs Needle-free blood sampling system 3 refs Pressure transducer green line® - Xtrans®/DPT-6000 9 refs Sampling adapter HG-01 2 refs Satellite, 1-fold - Plug Zubehör / Accessory IBPM 3 refs Stopcock, 4-way, blue SWAN Switch 3 refs Velcro Strip Zubehör / Accessory IBPM 3 refs
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Zimmer FDA
EU representative : Biomet Global Supply Chain Center B.V. (Netherlands)
Canada, Germany, United States
27 others
I, IIa, IIb
MDR, 93/42
Website
info@zimmer.de
EUDAMED record
Report an error
Keeler FDA
EU representative : Keeler Europe Distribution, S.L. (Spain)
United Kingdom (ex Northern Ireland)
27 others
I, IIa, IIb
MDR, 93/42
Website
regulatory@keeler.co.uk
EUDAMED record
Report an error
Beneware
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
26 others
IIa
93/42
Website
EUDAMED record
Report an error
implantcast FDA
Germany
26 others
IIa
MDR
Website
info@implantcast.de
EUDAMED record
Report an error
Jeilmed FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
26 others
IIa
MDR, 93/42
EUDAMED record
Report an error
Topcon FDA
EU representative : Topcon Europe Medical BV (Netherlands)
Japan
26 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Appasamy FDA
EU representative : Amstermed B.V. (Netherlands)
India
26 others
I, IIa, IIb
MDR, 93/42
Website
ramesh.jagadeesan@appasamy.com
EUDAMED record
Report an error
Lewinmed
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
25 others
I
MDR
Website
EUDAMED record
Report an error
Mechan
EU representative : SUNGO Europe B.V. (Netherlands)
China
25 others
IIb
93/42
sales@mechan.com.cn
EUDAMED record
Report an error
Quest Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
25 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Shenzhen Jiacom Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
China
Arm type automatic blood pressure monitor BP310A,BP311A,BP313A,BP315A,BP316A,BP317A,BP318A,BP319A,BP320A,BP351A,BP353A,BP358A,BP359A,BP360A,BP362A,BP366A,BP367A,BP368A,BP369A,BP370A,BP380A,BP382A,BP385A,BP386A,BP387A,BP388A,BP389A,BP390A,BP391A,BP-JC319,BP-JC312 3 refs BP-JC312 93/42 BP310A 93/42 BP311A 93/42 BP313A 93/42 25 others BP317A 93/42 BP320A 93/42 BP351A 93/42 BP353A 93/42 BP358A 93/42 BP359A 93/42 BP362A 93/42 BP366A 93/42 BP369A 93/42 BP380A 93/42 BP385A 93/42 BP387A 93/42 BP389A 93/42 BP390A 93/42 BP391A 93/42 Wrist type automatic blood pressure monitor BP-JC160 93/42 Wrist type automatic blood pressure monitor BP163W 93/42 Wrist type automatic blood pressure monitor BP166W 93/42 Wrist Type Automatic Blood Pressure Monitor BP168W 93/42 Wrist Type Automatic Blood Pressure Monitor BP168W, BP166W, BP169W, BP163W, BP165W, BP188W,BP189W, BP-JC160, BP180W, BP182W, BP183W,BP185W, BP186W, BP187W 3 refs Wrist type automatic blood pressure monitor BP169W 93/42 Wrist type automatic blood pressure monitor BP182W 93/42 Wrist type automatic blood pressure monitor BP183W 2 refs 93/42 Wrist type automatic blood pressure monitor BP185W 93/42 Wrist type automatic blood pressure monitor BP188W 93/42
IIa
MDR, 93/42
Website
info@szjiakang.com
EUDAMED record
Report an error
Technomex FDA
Poland
25 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Thor Sagli̇k Spor Malzemeleri̇ Ve Rehabi̇li̇taston Si̇stemleri̇ Medi̇kal Yazilim Sanayi̇ Ti̇caret Si̇rketi̇
Türkiye
25 others
I
MDR
Website
info@thormedikal.com
EUDAMED record
Report an error
Zeiss FDA
EU representative : Carl Zeiss Meditec AG (Germany)
China, Germany, United States
30 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
AMI FDA
EU representative : Obelis s.a. (Belgium)
Austria, South Korea
24 others
I, IIa, IIb
MDR, 93/42
info@ami.at
EUDAMED record
Report an error
Foshan SOCO Precision Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
China
24 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Hash Sign
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
24 others
I
MDR
EUDAMED record
Report an error
Steris FDA
EU representative : STERIS Ireland Ltd (Ireland)
Canada, Italy, United Kingdom (ex Northern Ireland), United States
24 others
I, IIa, IIb
MDR, 93/42
Website
ra-emea@steris.com
EUDAMED record
Report an error
Yishunmedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Cold & Hot Face Mask YS-MZ200, YS-MZ220,YS-MZ230,YS-MZ240,YS-MZ250 Fabric Bag YS-BBD05,YS-BBD06,YS-BBD07,YS-BBD09,YS-BBD11 2 refs Frozen Ice Pack YS-BDA50,YS-BDA100,YS-BDA150,YS-BDA200,YS-BDA250,YS-BDA500,YS-BDB50,YS-BDB100,YS-BDB150,YS-BDB200,YS-BDB250,YS-BDB500,YS-BDC50,YS-BDC100,YS-BDC150,YS-BDC200,YS-BDC250,YS-BDC500,etc. 2 refs Gel Sleeve YS-LRD50,YS-LRD60,YS-LRD100,YS-LRD120,YS-LRD130,YS-LRD140,YS-LRD150,YS-LRD200,YS-LRD220,YS-LRD250,YS-LRD270,YS-LRD280,YS-LRD320,YS-LRD350,YS-LRD430,YS-LRD475,YS-LRD500, YS-LRD600,etc 2 refs Hot Cold Eye Mask YS-YZ30,YS-YZ58,YS-YZ60,YS-YZ65,YS-YZ80,YS-YZ99,YS-YZ100,YS-YZ101,YS-YZ110,YS-YZ120,YS-YZ125,YS-YZ130,YS-YZ140,YS-YZ150,YS-YZ160,YS-YZ180,YS-YZ80,YS-YZ160,YS-YZ200,YS-YZ240,YS-YZ260,YS-BQ125,YS-YT4,YS-YT6,YS-YT10,YS-YT15,YS-YT20 24 others Hot Cold Pack YS-LRA50,YS-LRA60,YS-LRA100,YS-LRA120,YS-LRA130,YS-LRA140,YS-LRA150,YS-LRA170,YS-LRA200,YS-LRA220,YS-LRA250,YS-LRA270,YS-LRA280,YS-LRA320,YS-LRA350,YS-LRA475,YS-LRA500,YS-LRA520,YS-LRA540,YS-LRA550,YS-LRA560,YS-LRA580,YS-LRA600,YS-LRA650,YS-etc 3 refs Hot Cold Pack YS-LRB50,YS-LRB60,YS-LRB100,YS-LRB120,YS-LRB130,YS-LRB140,YS-LRB150,YS-LRB180,YS-LRB200,YS-LRC40,YS-LRC50,YS-LRC55,YS-LRC60,YS-LRC70,YS-LRC85,YS-LRC100,YS-LRC120,YS-LRC130,YS-LRC140,YS-LRC150,YS-LRC200,etc 3 refs Hot Compress Pack YS-RFA165,YS-RFA245,YS-RFA265,YS-RFA380,YS-RFA420,YS-RFB150,YS-RFB370,YS-RFB450,YS-RFB500,YS-RFB570,YS-RFB800,YS-RFB950,YS-RFB1130,etc. 2 refs Hot Pack YS-NSD100 93/42 Hot Pack YS-NSD110 93/42 Hot Pack YS-NSD25 93/42 Hot Pack YS-NSD25,YS-NSD35,YS-NSD40,YS-NSD60,YS-NSD63,YS-NSD65,YS-NSD70,YS-NSD75,YS-NSD80,YS-NSD90,YS-NSD100,YS-NSD110,YS-NSD600,YS-NSD1000 2 refs Hot Pack YS-NSD35 93/42 Hot Pack YS-NSD40 93/42 Hot Pack YS-NSD60 93/42 Hot Pack YS-NSD65 93/42 Hot Pack YS-NSD70 93/42 Hot Pack YS-NSD75 93/42 Hot Water Bag YS-RFA165,YS-RFA245,YS-RFA265,YS-RFA380,YS-RFA420 2 refs Instant Cold Pack YS-SL100 93/42 Instant Cold Pack YS-SL100,YS-SL110,YS-SL133,YS-SL160,YS-SL180,YS-SL200,YS-SL220,YS-SL225,YS-SL280,YS-SL290 3 refs Instant Cold Pack YS-SL133 93/42 Instant Cold Pack YS-SL160 93/42 Instant Cold Pack YS-SL250 93/42 Instant Cold Pack YS-SL280 93/42 Instant Cold Pack YS-SL290 93/42 Instant Hot Pack YS-SR100 93/42 Instant Hot Pack YS-SR100,YS-SR250 2 refs Instant Hot Pack YS-SR250 93/42
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Zero-Plus International
EU representative : Globalmind consumer electronics GmbH (Germany)
Hong Kong SAR China
24 others
IIa
93/42
EUDAMED record
Report an error
Bosch Sohn U
Germany
23 others
I
93/42
Website
EUDAMED record
Report an error
DXL Medical
Germany
23 others DXL Plus Paralel Drill Hard Ø3,2 Yellow III 93/42 DXL Plus Parallel Drill Soft Ø3,0 Yellow I 93/42 DXL Plus Parallel Drill standard Ø3,1 Yellow II 93/42 DXL Ø1,8 Short Drill 93/42 DXL Ø3,0 Return Drill 93/42 DXL Ø3,4 Short Drill 93/42 DXL Ø3,8 Short Drill 93/42 DXL Ø4,4 Short Drill 93/42 DXL-Parallel Drill Hard Ø4,7 Blue III 93/42 DXL-Parallel Drill Soft Ø1,8 Pink I 93/42 DXL-Parallel Drill Soft Ø4,4 Blue I 93/42 DXL-Parallel Standard Ø4,6 Blue II 93/42 DXL-Pilot Drill (Cortical) 93/42 DXL-Smart Screw Tap Ø4,1 Green 93/42 DXL-Smart Screw Tap Ø4,8 Blue 93/42 DXL-Stop Drill Ø3,3 Pink 93/42 DXL-Stop Drill Ø3,4 Yellow 93/42 DXL-Stop Drill Ø3,7 Red 93/42 DXL-Stop Drill Ø4,1 Green 93/42 DXL-Stop Drill Ø4,5 93/42 DXL-Stop Drill Ø4,8 Blue 93/42 DXL-Stop Drill Ø5,0 93/42 Universal Drill Extention 93/42
IIa
93/42
Website
EUDAMED record
Report an error
Fisioline FDA
Italy
23 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Guangdong Biolight Meditech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
23 others Fingertip Pulse Oximeter M70, M70A, M70B, M70C, M70D 3 refs Haemodialysis equipment D800Plus, D800H, D800S, D50 3 refs Handheld monitor M850 Handheld monitor M860 Handheld monitor M880 Infusion Pump BioFusion M500, BioFusion M500 Ex, BioFusion M500 Pro, Evadrop V10 3 refs Infusion Pump BioFusion S500, BioFusion S500 Neo, BioFusion S500 Ex, BioFusion S500 Pro, BioFusion P500, BioFusion P500 Neo, BioFusion P500 Ex, BioFusion P500 Pro, CODAN 907 V 3 refs Infusion Supervision System BioFusion DS100, BioFusion DS100T, BioFusion DS100Pro, BioFusion DS100T Pro, CODAN 200 D, CODAN 400 DD 3 refs Patient monitor G10, G12, G15, G10A, G12A, G15A 3 refs Patient monitor M10, Truscope M10 2 refs Patient monitor M1000, TRUSCOPE touch mini 2 refs Patient monitor M12 patient monitor P1, Truscope P1, LM1, 3 refs Patient monitor P12, P15, P18, P22, Truscope P12, Truscope P15, Truscope P18, Truscope P22, LM 15, LM 18 3 refs Patient monitor Q3, Q5, Q7, TRUSCOPE Ultra Q3, TRUSCOPE Ultra Q5, TRUSCOPE Ultra Q7, PG S30, PG S50, PG S70, LM7 3 refs Patient monitor S10, S10A 2 refs Patient monitor S12, S12A, LM12 3 refs Pulse Oximeter M800 Syringe Pump BioFusion M300, BioFusion M300 Ex, BioFusion M300 Pro, Evadrop V20 3 refs Syringe Pump BioFusion S300, BioFusion S300 Neo, BioFusion S300 Ex, BioFusion S300 Pro, BioFusion P300, BioFusion P300 Neo, BioFusion P300 Ex, BioFusion P300 Pro, CODAN 806 S 3 refs Video Laryngoscope BioView C100 Vital signs monitor V6 Vital signs monitor V9
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Megoafek FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
23 others
I, IIa
MDR
Website
info@megoafek.com
EUDAMED record
Report an error
SOMNOmedics FDA
Germany
23 others
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Yuyue FDA
EU representative : Metrax GmbH (Germany)
China
23 others Alltimes 7F-5B Alltimes 8F-5A Electronic blood pressure monitor YE630CR Electronic blood pressure monitor YE660D, YE610D, YE610F, YEC30, YEC31, YEC60 3 refs Electronic blood pressure monitor YE670A, YE666A, YE666B, YES60, YE690C, YE690D 3 refs Electronic blood pressure monitor YE670CR, YE650AR 2 refs Electronic blood pressure monitor YE680B,YE660F,YE660E,YE620B 3 refs Electronic blood pressure monitor YE8300B Positive Airway Pressure Units ET3, ET5, ET5 Elite, ET5 Pro, ET6, ET6 Elite 3 refs Positive Airway Pressure Units Pocket X, Pocket Y, Pocket E, Pocket S 3 refs Positive Airway Pressure Units YH-350, YH-550 3 refs Positive Airway Pressure Units YH-360, YH-560, YH-580 3 refs Positive Airway Pressure Units YH-450, YH-480 3 refs Positive Airway Pressure Units YH-680A, YH-680B, YH-690A, YH-690B 3 refs Positive Airway Pressure Units YH-720, YH-725, YH-730 3 refs Positive Airway Pressure Units YH-820, YH-825, YH-830, YH-820Auto, YH-825Auto 3 refs Positive Airway Pressure Units YH-920, YH-925, YH-930, YH-920Auto, YH-925Auto, YH-920ASV, YH-925ASV, YH-930Lab 3 refs SP-6 Spirit-3 YE650D, YE650A YE8800AR,YE8800CR 2 refs YE990, YE991, YE992, YE993 YUWELL® Finger Pulse Oximeter YX102, YX105, YX106, YX110,YX301, YX306, YX310 3 refs
IIa, IIb
MDR
qa.yuwell@yuyue.com.cn
EUDAMED record
Report an error
Özcan Kardeşler Tip Ci̇hazlari Sanayi̇ Ve Ti̇caret Şti̇
Türkiye
23 others
IIb
93/42
Website
EUDAMED record
Report an error
Maquet FDA
France, Germany
28 others
I, IIa
MDR, 93/42
Website
info.zentrale@getinge.com
EUDAMED record
Report an error
Bscience
Türkiye
22 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
CeramOptec FDA
Germany, Latvia
22 others
IIa, IIb
MDR, 93/42
Website
infolv@ceramoptec.com
EUDAMED record
Report an error
Insulet FDA
EU representative : Insulet Netherlands B.V. (Netherlands)
United States
22 others
IIb, III
MDR, 93/42
Website
EUDAMED record
Report an error
Livetec
Germany
22 others
IIa, IIb
MDR, 93/42
Website
info@livetec.de
EUDAMED record
Report an error
Mes
Poland
22 others Spirometr Lungtest Basic bez komputera, bez bazy SQL Lungtest Basic without computer, without SQL Base 93/42 Spirometr Lungtest Basic bez komputera, bez bazy SQL, z opcjami PIPE i wzorzec oddechowy P0.1 Lungtest Basic, no computer, no SQL Base, PIPE, Breath Pattern with P0.1 93/42 Spirometr Lungtest Basic bez komputera, bez bazy SQL, z opcjami RRS, DRT, Wzorzec Oddechowy P0.1 Lungtest Basic, no computer, no SQL, RRS, DRT , Brearh Pattern P0.1 93/42 Spirometr Lungtest Basic bez komputera, bez bazy SQL, z opcją PIPE Lungtest Basic, PIPE, no computer, no SQL 93/42 Spirometr Lungtest Basic z komputerem 93/42 Spirometr Lungtest Basic z kopmuterem bez bazy SQL Lungtest Basic, computer, SQL 93/42 Spirometr Lungtest Basic z kopmuterem i opcją RRS Lungtest Basic, RRS, no computer 93/42 Spirometr Lungtest Basic z opcją RRS i komputerem Lungtest Basic, RRS, computer 93/42 Spirometr Lungtest Basic z SQL, bez komputera Lungtest Basic without computer 93/42 Spirometr Lungtest Handy bez komputera z bazą SQL Lungtest Handy without computer with SQL base 93/42 Spirometr Lungtest Lab bez komputera Lungtest Lab, no computer 93/42 Spirometr Lungtest Lab Body bez komputera Lungtest Lab Body, no computer 93/42 Spirometr Lungtest Lab Body bez komputera ze spirometrią Lungtest Lab Body, no computer, spirometry 93/42 Spirometr Lungtest Lab Body Lungtest Lab Body, computer 93/42 Spirometr Lungtest Lab Body z komputerem i spirometrią Lungtest Lab Body, computer, spirometry 93/42 Spirometr Lungtest Lab z komputerem i opcją Dyfuzja Lungtest Lab, computer, Diffusion 93/42 Spirometr lungtest Lab z komputerem i wzorcem oddechowym P0.1 Lungtest Lab, computer, breath pattern P0.1 93/42 Spirometr Lungtest Lab z komputerem Lungtest Lab, computer 93/42 Spirometr Lungtest LAB z komputerem, z opcjami Dyfuzja, DRT, PIPE Lungtest LAB, computer, Dyfuzja, DRT, PIPE 93/42 Spirometr Lungtest Lab z komputerem, z opcjami Dyfuzja, RRS, PIPE Lungtest Lab, Duffusion, RRS, PIPE, computer 93/42 Spirometr Lungtest LAB z komputerem, z opcjami RRS, Wzorzec oddechowy P.01, Wzorzec oddechowy E, PIPE Lungtest LAB, computer, RRS, Breath Pattern P.01, Breath Pattern E, PIPE 93/42 Spirometr Lungtest Lab z opcją ISPA Lungtest Lab, computer, ISPA 93/42
IIa
93/42
Website
EUDAMED record
Report an error
Solta FDA
EU representative : MDSS GmbH (Germany)
United States
22 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Kinesis
Poland
24 others
I
MDR
Website
EUDAMED record
Report an error
Compumedics FDA
EU representative : Compumedics EUROPE GmbH (Germany)
Australia
21 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
İstanbul Medi̇kal Şti̇
Türkiye
21 others
IIb
93/42
Website
sales@istanbulmedical.com
EUDAMED record
Report an error
Labotech Microscopes India
EU representative : Labomed Europe b.v. (Netherlands)
India
Labomed 6121025,6121035P,6122015 3 refs Labomed 6128000 / 6128600 3 refs Labomed 6129000-890 ,6133351 ,6133350,6133352,6133400,6133300,6133250,6133201-000,6133200,6133176-000 3 refs Labomed 6129013 , 6129011,6132013,6122011,6120011 3 refs Labomed 6129304 3 refs 21 others Labomed 6134117 , 6134115-801R,6134165,6214051 Labomed 6134132-S ,6134132-C ,6134131S,6134131N,6134131-C,6134180,6134134,6134110-800 Labomed 6134162,6134160,6134152,6134150,6134135,6122500,6122501 3 refs Labomed 6135000 /6136000 2 refs LABOMED 6137000 3 refs Labomed 6137400 Labomed 6137500-800 , 6137100 ,6137300,6137200 3 refs LABOMED 6138000 3 refs Labomed 6165000 / 6165000-100 2 refs Labomed 6165000-220,6165000-221,6165000-222,6165000-223,6165000-224,6165000-225,6165000-226,6165000-227,6165000-228,6165000-229,6165000-230,6165000-231 3 refs Labomed 6165000-840,6165000-821,6165000-901 Labomed 6165000-859 Labomed 6165000-863 Labomed 6167500 Labomed 6169200 / 6169000 2 refs Labomed 6211000 2 refs Labomed 6214000 Labomed 6219100 /6219101 /6219103 /6219104 3 refs Labomed 6219200 / 6219201 2 refs LABOMED 8127303,8126303.8127300,8126300,8127201,8126201,8127200,8126200,8127401,8126401,8127400,8126400,8127701,8126701,8127700,8126700 3 refs LABOMED Prima Mu ENT microscope -6212000 2 refs
I
MDR
EUDAMED record
Report an error
Miglionico
Italy
21 others
IIa
93/42
Website
info@miglionico.net
EUDAMED record
Report an error
Paltop Advanced Dental Solutions FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
United States
21 others Final Drill for Ø3.25mm Implant, Short 93/42 Final Drill for Ø3.75mm Implant 93/42 Final Drill for Ø3.75mm Implant, Short 93/42 Final Drill for Ø3mm Implant, Long 93/42 Final Drill for Ø4.2mm Implant 93/42 Final Drill for Ø4.2mm Implant, Short 93/42 Final Drill for Ø4.2mm L6mm Implant 93/42 Final Drill for Ø5mm Implant 93/42 Final Drill for Ø5mm Implant, Short 93/42 Final Drill for Ø5mm L6mm Implant 93/42 Final Drill for Ø6mm Implant, Long 93/42 Step Drill Ø1.5/2mm, Long 93/42 Step Drill Ø1.5/2mm, Short 93/42 Step Drill Ø2.0/2.4mm, Short 93/42 Step Drill Ø2.4/3.2mm, Long 93/42 Step Drill Ø3.2/3.8mm, Long 93/42 Step Drill Ø3.8/4.3mm, Long 93/42 Step Drill Ø3.8/4.3mm, Short 93/42 Step Drill Ø4.3/5.3mm, Long 93/42 Tissue Punch Ø4mm 93/42 Tissue Punch Ø5mm 93/42
IIa
93/42
Website
customersupport@keystonedental.com
EUDAMED record
Report an error
Scivitamedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3D Visualization System 3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E 3 refs 4K UHD Arthroscope 4K4000,4K4030,4K4070 3 refs 4K UHD Camera System EL-4K81/82C, EL-4K82/82C 2 refs 4K UHD Camera System ES-CS4K100/100C,ES-CS4K100/200C,ES-CS4K200/200C,ES-CS4K200/100C 3 refs 4K UHD Laparoscope 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR) 3 refs 21 others 4K UHD Sinuscope 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070R 3 refs 4KINSIGHT UHD Fluorescence Imaging System 4KIR01 4KIR02 4KIR03 4KIR04 4KIR05 4KIR06 4KIR07 4KIR08 4KIR09 4KIR10 4KIR11 4KIR12 2 refs Endoscopic Image Processor HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S100E 3 refs Full HD Endoscopic Image Processor HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D 3 refs Full HD Visualization Endoscopic Image Processor HDVS-S300A、 HDVS-S300B、 HDVS-S300C、 HDVS-S300D 3 refs Insufflator SL101 Insufflator SL102 LED Light Source ES-LS100D,ES-LS110D 2 refs Near-infrared LED Light Source LSIR300 LSIR310 LSIR320 LSIR330 3 refs Omni Power System PS-100 Single-use Flexible Ureteroscope SUV-(1A-B,1A-P,2A-B,2A-P,2B-B,2B-P,2C-B,2C-P,3A-B,3C-B,4A-B,4C-B,1A-BF, 2A-BF, 2B-BF, 2C-BF, 3C-BF, 4C-BF, 1F-BF, 2F-BF), SUVB-(1F-BF , 2F-BF),SUVC-(1F-BF, 2F-BF), SUVG-(1F-BF, 2F-BF),SUVI-1F-BF, SUVE-1F-BF 3 refs Single-use Broncho Videoscope SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P 3 refs Single-use Choledocho Videoscope SCV-BA1 、SCV-BA2 、SCV-PA1 、SCV-PA2 3 refs Single-use Flexible Cystoscope SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-B 3 refs Single-use Hystero Videoscope SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LN 3 refs Single-use Hystero Videoscope SHV-B1,SHV-P1,SHV-B2,SHV-P2 3 refs Single-use Hystero Videoscope SHV-S1，SHV-S2 2 refs Single-use Resecting Device BHA-4032, BHA-4035, BHA-2932, BHA-2935, BHB-4032, BHB-4035, BHB-2932, BHB-2935 3 refs Single-use Video Arthroscope SAV-4000、SAV-4030 2 refs Single-use Video Cholangioscope SCV-P-01G，SCV-P-02G，SCV-P-03G，SCV-P-04G，SCV-P-05G 3 refs Single-use Video Transforaminal Endoscope SSV-5823、SSV-5823L、SSV-6315、SSV-6323、 SSV-6323L、SSV-7023、SSV-7315、SSV-7315L、SSV-7323、SSV-1015、SSV-1015L 3 refs
I, IIa
MDR
Website
info@scivitamedical.com
EUDAMED record
Report an error
Siem Nova
Italy
21 others
I, IIa
MDR, 93/42
Website
info@siemnova.it
EUDAMED record
Report an error
Uzumcu
Türkiye
21 others Nurse Call Systems 4130.xx Operating Room Ceiling Light - 3x68 Head DL-6CM, DL-62CM, DL-66CM, DL-666D, DL-662D, DL-62C, DL-62D, DL-6D, DL-66D, DL-2D, DL-66C, DL-6M, DL-2CM, DL-22D, DL-6C, DL-66CMW, DL-62CMW, DL-66A, DL-666A, DL-2A, DL-66CR, DL-62A, DL-622D, DUO LEDX1, 135.E002,135.E003,135.E004,135.E005,135.E006,135.E007 3 refs Surgical Suction Unit, Liposuction Novela 93/42 Surgical Suction Unit, Main Unit Novela 93/42 Surgical Suction Unit, Main Unit Novela Extractor 93/42 Surgical Suction Unit, Toraks Novela 93/42 Surgical Suction Unit, With 2x2lt Dısposable Jar Novela 93/42 Surgical Suction Unit, With 2x3lt Dısposable Jar Novela 93/42 Surgical Suction Unit, With 2x3lt Plastic Jar Novela 93/42 Surgical Suction Unit, With 2x3lt Plastic Jar Novela Extractor 93/42 Surgical Suction Unit, With 2x5lt Plastic Jar Novela 93/42 Surgical Suction Unit, With 2x5lt Plastic Jar Novela Extractor 93/42 Surgical Suction Unit, With Mobile Stand VELA 93/42 UZUMCU 93/42 UZUMCU 1002.51 93/42 UZUMCU AMB 93/42 UZUMCU Novela 93/42 UZUMCU NOVELA SENSEO 93/42 UZUMCU PA-1R 93/42 UZUMCU PA-2 93/42 UZUMCU PA-2S 2 refs 93/42
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Vathin FDA
EU representative : Lotus NL B.V. (Netherlands)
China
21 others BCV1-01 93/42 BCV1-02 93/42 BCV1-C1 93/42 BCV1-C2 93/42 BCV1-H1 93/42 BCV1-H2 93/42 BCV1-K1 93/42 BCV1-K2 93/42 BCV1-KS3-L 93/42 BCV1-M1 93/42 BCV1-O1 93/42 BCV1-O2 93/42 BCV1-U1 93/42 BCV1-W1 93/42 Digital Video Monitor (DVM-A1) DVM-A1,DVM-A2 2 refs Digital Video Monitor (DVM-B1) DVM-B1， DVM-B2 Digital Video Monitor (DVM-D1) DVM-D1, DVM-D2 2 refs DVP-A1 93/42 Models: US01 series: US-S170, US-S180, US-E170, US-E180, US-S170R, US-E170R; US02 series: US-S2600, USE2600, US-S2600R, US-E2600R, US-S2602, US-E2602, USS2602R, US-E2602R 3 refs Single-use Flexible Bronchoscope: BC-S1E00, BC-S1H00, BC-S1J00,BC-S1E00-L, BC-S1H00-L, BC-S1J00-L，BC-E1C10、BC-E1C11、BC-E1C12、BC-E1E10、BC-E1E11、BC-E1E12、BC-E1H10、BC-E1H11、BC-E1H12、Single-use sampler: S-20mL、S-30mL、S-50mL 3 refs Single-use Flexible Cystoscope CY-E2E01 3 refs
I, IIa
MDR, 93/42
Website
service@vathin.com
EUDAMED record
Report an error
Viatomtech FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
China
21 others Checkme ER2-S Checkme ER2-SC Checkme Lite 93/42 Checkme M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12 3 refs Checkme Plus 93/42 Checkme Pod 93/42 Checkme Pro 93/42 LEPU MEDICAL BP3, BP3D, BP3K, HDM3, HDM3D, HDM3K 3 refs LEPU MEDICAL LeRes-S, LeRes-A, LeRes-B, LeRes-C, R100, R10, R200, R20 3 refs LEPU MEDICAL PF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B1 3 refs LEPU MEDICAL PO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-S 3 refs LEPU MEDICAL XAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-12 3 refs PF-10AW 93/42 PO1B 93/42 PO4 93/42 PO6 93/42 Viatom Oxiband、Oxiduck、Oximax、Oxiduckm、Oxiultra、Oxiultra01、Oxiducku、Oxiduckp 3 refs Viatom PO6、PO6A、 PO1、 PO1B 2 refs Viatom VTM01、VTM01A、VTM01B 2 refs VTM01A 93/42 Wellue PO6B、PO6C 2 refs
IIa
MDR, 93/42
EUDAMED record
Report an error
Чек Пойнт Ар енд Ди ООД
Bulgaria
21 others
IIb
93/42
Website
EUDAMED record
Report an error
A. S. Technology Componentes Especiais LTDA
EU representative : Eurofix - Implantes e Componentes Dentários, Lda. (Portugal)
Brazil
33 others
IIa
93/42
EUDAMED record
Report an error
Enraf-Nonius FDA
Netherlands
21 others
I, IIa, IIb
MDR, 93/42
Website
info@enraf-nonius.nl
EUDAMED record
Report an error
Alan Electronic Systems
EU representative : Meddevices Lifesciences B.V. (Netherlands)
India
20 others
IIb
93/42
EUDAMED record
Report an error
Amnotec
Germany
20 others Cystoscopes, reusable 3 refs Drahthalte-/ Drahtbiegezangen, wiederverwendbar Wire-holding and wire-bending forceps 25 refs 93/42 Fingernagel-Bohrer, wiederverwendbar Fingernail drills Gipsmesser, wiederverwendbar Plaster knives 3 refs Hysteroscopes, reusable 3 refs Laparoscopes, reusable 3 refs Laryngoscope handles, reusable 3 refs Laryngoscope holders, reusable 3 refs Laryngoscope light carriers, reusable 3 refs Laryngoscopes, reusable 5 refs Lichtquellen, wiederverwendbar 3 refs Nicht sterile genutete Chirurgiebohrer, wiederverwendbar Non-sterile grooved surgical drills 2 refs 93/42 Objectives, reusable 3 refs Otoscopes, reusable 3 refs Pelvimeters, reusable Resectoscopes, reusable 3 refs Rhinoscopes, reusable 3 refs Thoracoscopes, reusable 3 refs Ureterorenoscopes, reusable 3 refs Wire-holding and wire-bending forceps, reusable 23 refs 93/42
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Apolo FDA
EU representative : Lotus NL B.V. (Netherlands)
China
20 others
IIa, IIb
93/42
EUDAMED record
Report an error
Candela FDA
EU representative : AR Experts B.V. (Netherlands)
United States
20 others
IIa, IIb
93/42
EUDAMED record
Report an error
Cowellmedi FDA
EU representative : AR Experts B.V. (Netherlands)
South Korea
20 others
IIa
MDR
Website
EUDAMED record
Report an error
Crimson International FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
20 others
I
MDR
Website
info@crimson-intl.com
EUDAMED record
Report an error
FREI medical
Germany
20 others
I
MDR
Website
info@frei-ag.de
EUDAMED record
Report an error
Fujifilm FDA
EU representative : FUJIFILM Healthcare Europe GmbH (Germany)
Japan
20 others
I, IIa
MDR
EUDAMED record
Report an error
Hologic FDA
EU representative : Emergo Europe B.V. (Netherlands) and 1 other
United States
20 others
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Okuman
Türkiye
20 others
IIb
93/42
Website
info@okuman.com.tr
EUDAMED record
Report an error
Prohs
Portugal
20 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Shenzhen Everbest Machinery lndustry
EU representative : Lotus NL B.V. (Netherlands)
China
20 others
IIa
MDR
EUDAMED record
Report an error
Sino-Hero(Shenzhen) Bio-Medical Electronics
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
20 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Tecno-Gaz FDA
Italy
20 others
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Sino Medical-Device Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
44 others
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Carlreiner
Austria
19 others Jet Coupling for SHFJV® acc. to ALOY, with EasyConnect™, for Adults 3 refs Jet Laryngoscope for SHFJV® acc. to ALOY, Type BENJAMIN, Size 8574 SL Jet Laryngoscopes and Jet Tracheoscopes 3 refs Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER, Size 8590 JL Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER-RUDERT, Size 8590 D Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER-RUDERT, Size 8590 J Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type KLEINSASSER-RUDERT, Size 8590 JA Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type POLYGONAL, Size A Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type POLYGONAL, Size B Jet Laryngoscopes 93/42 Jet Laryngoscope for SHFJV® acc. to ALOY, Type POLYGONAL, Size C Jet Laryngoscopes 93/42 Jet Laryngoscope, distending, for SHFJV® acc. to ALOY, Type WEERDA, Size 12067 A Jet Laryngoscopes 93/42 Jet Laryngoscope, distending, for SHFJV® acc. to ALOY, Type WEERDA, Size 8588 A Jet Laryngoscopes 93/42 Jet Laryngoscope, distending, for SHFJV® acc. to ALOY, Type WEERDA, Size 8588 B Jet Laryngoscopes 93/42 Jet-Ventilation tubing set, EvoConnect™ to EasyConnect™, single use 3 refs Jet-Ventilation tubing set, EvoConnect™ to EasyConnect™, single use, sterile Jet-Ventilation Tubing Set Sterile 3 refs JetBRO™ EVO ADPT 15 - O2/ManV Emergency Adaptor Monitoring Cannula with EasyConnect™ for rigid standard Bronchoscopes, 1 Lumen for A, 20 cm 3 refs Titanium handle for Jet Laryngoscope Tubes EVO, LARGE EVOscope Handles 3 refs TwinStream EVO TwinStream SHFJV 93/42
I, IIa, IIb
MDR, 93/42
Website
office@carlreiner.at
EUDAMED record
Report an error
Euronda FDA
Italy
19 others
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Guangdong Transtek Medical Electronics FDA
EU representative : MDSS GmbH (Germany) and 1 other
China
19 others Blood Pressure Monitor BB2284-AE01 Blood Pressure Monitor BBY31-BT1, BBY31-1, BBY36-BT1, BBY36-1 3 refs Blood Pressure Monitor TMB-2296-B 2 refs Blood Pressure Monitor TMB-1490-CS 93/42 Blood Pressure Monitor TMB-2266, TMB-2271, TMB-2271-B, TMB-2271-BK, TMB-2271-A, TMB-2284, TMB-2284-B, TMB-2284-T, TMB-2275, TMB-2275-B, TMB-2275-K, TMB-2272-ZY, TMB-2272-AZY, TMB-1775-ZY, TMB-2276, TMB-2276-B, TMB-2276-A 3 refs Boots BBY31-BT, BBY31, BBY36-BT, BBY36 BRAUN BUA6400CEME, BUA6400WE 2 refs CELIMED CL3 TMB-2084-N 93/42 Checkme 3 refs Corsano TMB-2084-A 93/42 ETA TMB-1583-BS 93/42 EZVIZ CS-WBP1-E FLEMING TMB-1872-A 93/42 MEDISANA TMB-2287-BK ProBP 2000 Digital Blood Pressure Device 2 refs TeleRPM TMB-2092-G 2 refs TRANSTEK TMB-1491-AS 93/42 TRANSTEK TMB-1970 93/42 Withings BPM Pro 2 WPM07 2 refs
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Hikimaging
EU representative : SUNGO Europe B.V. (Netherlands)
China
19 others
I
MDR
Website
EUDAMED record
Report an error
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Şi̇rketi̇ Kahramankazan Şubesi̇
Türkiye
19 others
IIb
93/42
Website
EUDAMED record
Report an error
Xuzhou Yongkang Electronic Science Technology FDA
EU representative : Prolinx GmbH (Germany)
China
19 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Cattani
Italy
18 others
IIa
93/42
info@cattani.it
EUDAMED record
Report an error
Dixion
Germany
18 others
I, IIa, IIb
MDR
Website
info@dixion.de
EUDAMED record
Report an error
Guilin Woodpecker Medical Instrument FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany) and 1 other
China
18 others CA 161 3 refs D-Laser 16 93/42 D600 3 refs Dental Electric Motor MT2、MT3、ES5、ES5+、ES5 Pro、ES5 Pro+、M2 Pro、M2、M3 3 refs Dental Low Speed Handpiece WJ-45/WJ-45L/WJ-95L/WJ-45T/WJ-45TL/WJ-SG45/WJ-SG45L/WJ-SG45T/WJ-SG45TL/WJ-SG45C/WJ-SG45CL/WJ-SG15/WJ-SG15L 3 refs Dental Scaler and Air Polisherh AP-B 93/42 EDGEACTIVATOR 2 refs EDGEGUTTA GRIP 3 refs Endo Motor Endo Pace 93/42 Gutta Percha Obturation Device Fi-P 93/42 HP33-K Implant Air Z121101 LX 16 93/42 Piezo Bone Surgery Surgery-X,Surgery-X LED,Surgic Touch LED,Surgic Touch,US-II,DS-II,ULTRASURGERY,US-II LED,DS-II LED,Ultrasurgery LED, 93/42 PT-A 3 refs U-Light 2 refs Ultrasonic Scalers V6、V6 LED、UDS-N6、UDS-N6 LED 93/42 YZ-2L(BAC5L)
I, IIa, IIb
MDR, 93/42
Website
sales@glwoodpecker.com
EUDAMED record
Report an error
JOYTECH Healthcare FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
18 others
IIa
MDR, 93/42
info@sejoy.com
EUDAMED record
Report an error
LM-Instruments FDA
Finland
18 others PP Ultra std Built-in (B)detachable Ultrasonic device for professional dental care, built-in 93/42 PP Ultra std Built-in (C)detachable Ultrasonic device for professional dental care, built-in 93/42 PP Ultra std Built-in (D)detachable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED Built-in (B),LED detachable & autoclaveable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED Built-in (C),LED detachable & autoclaveable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED Built-in (D),LED detachable & autoclaveable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED Built-in /Planmeca Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std (bin)(ErgoGrip Blue, Tips 37,38,39) Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std Bin(B) (ErgoGrip LightGrey,PE-37,PE-39,PE-41PS) Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std Built-in (B)LED, detachable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLed Std Built-in (C)(ErgoGrip Grey, 2xPE37,2xPE39) Ultrasonic device for professional dental care, built-in 93/42 PP UltraLed Std Built-in (C)LED detachable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std Built-in (D) LED, detachable Chirana ErgoGrips, LM branded Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std Built-in (D)LED, detachable (ErgoGrip light grey, PE-37,PE-39,PE-41PS) Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std Built-in (D)LED, detachable Ultrasonic device for professional dental care, built-in 93/42 PP UltraLED std Built-in(B)LED(ErgoGrip Blue, 2xPE37,2xPE39) Ultrasonic device for professional dental care, built-in 93/42 PP UltraLed Std Built-in(C)LED (ErgoGrip Grey, PE-37,PE-39,PE-41PS) Ultrasonic device for professional dental care, built-in 93/42 PP UltraLed Std Built-in(C)LED(ErgoGrip Grey, 2*PE37,2*PE39) Ultrasonic device for professional dental care, built-in 93/42
IIa
93/42
Website
info@lm-dental.com
EUDAMED record
Report an error
Medinux FDA
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
18 others
IIb
MDR
Website
EUDAMED record
Report an error
Stryker FDA
EU representative : Stryker European Operations Limited (Ireland)
Germany, United States
18 others
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Sigmastim FDA
EU representative : ICON (LR) Limited (Ireland)
United States
27 others
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Haag-Streit FDA
EU representative : Haag-Streit Deutschland GmbH (Germany)
Switzerland
21 others
I, IIa, IIb
MDR, 93/42
Website
regulatory@haag-streit.com
EUDAMED record
Report an error
Abbott FDA
EU representative : Abbott B.V. (Netherlands) and 1 other
United Kingdom (ex Northern Ireland), United States
17 others
I, IIa, IIb, III
MDR, 93/42
EUDAMEDInq_EP@abbott.com
EUDAMED record
Report an error
Codyson FDA
EU representative : Abmed Medical Technology Limited (Ireland)
China
17 others
I
MDR
Website
info@codyson.net
EUDAMED record
Report an error
Cynosure FDA
EU representative : Cynosure B.V. (Netherlands)
United States
17 others
IIa, IIb
93/42
Website
Regulatory2@cynosurelutronic.com
EUDAMED record
Report an error
InBody FDA
EU representative : InBody Europe B.V. (Netherlands)
South Korea
17 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Microlife FDA
EU representative : Microlife UAB (Lithuania)
Taiwan
17 others
IIa
MDR, 93/42
info@microlife.com.tw
EUDAMED record
Report an error
Shenzhen Creative Industry FDA
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) and 1 other
China
17 others
IIa, IIb
MDR, 93/42
Website
info@creative-sz.com
EUDAMED record
Report an error
Silverfox FDA
EU representative : Lotus NL B.V. (Netherlands)
China
17 others
I
MDR
Website
sales@silverfox.cn
EUDAMED record
Report an error
Airliquide FDA
France, Italy
17 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Biomag
Czechia
17 others
IIa
MDR
Website
EUDAMED record
Report an error
Adin Dental Implant Systems FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
16 others
IIa
MDR
info@adin-implants.com
EUDAMED record
Report an error
devemed FDA
Germany
16 others
IIa
93/42
Website
info@devemed.de
EUDAMED record
Report an error
Gimmi FDA
Germany
16 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Optomedic FDA
EU representative : Share info GmbH (Germany)
China
Endoscopic Fluorescence Camera Head OPTO-CHD2100,71-066-10 NIR 2 refs Endoscopic Fluorescence Camera Head OPTO-CHD214KE, OPTO-CHD214KH,71-068-10 NIR,71-068-10 NIR-CA, 71-068-20 NIR,71-068-20 NIR-CA 3 refs FloNavi Image Processing Unit OPTO-CAM2100,71-066-05 NIR FloNavi Image Processing Unit OPTO-CAM214K,71-068-05 NIR,71-068-05 NIR-CA 3 refs FloNavi Light source OPTO-LED2100,71-180-30 NIR 2 refs 16 others FloNavi Light source OPTO-LED214K,71-182-30 NIR,71-182-30 NIR-CA 2 refs Insufflator(with Insufflation Tube and Gas Filter) 4050039 Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC 3 refs Laparoscope 21033SA,21033SC 2 refs Light source SL10 Light source SL20 Stellar 3D Camera Head SC10D Stellar 3D Fluorescence Camera Head SC20D Stellar 3D Fluorescence Camera Head SC30D Stellar Camera Head SC10E Stellar Fluorescence Camera Head SC20E Stellar Light Source SL30 Stellar SC30E WhtNavi OPTO-CAM104K WhtNavi OPTO-CHD104KH WhtNavi OPTO-LED104K
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Photon 4 Health
Netherlands
16 others
I
MDR
Website
info@photon4health.com
EUDAMED record
Report an error
Scorpion
France
16 others
IIa
MDR, 93/42
Website
contact@scorpion.fr
EUDAMED record
Report an error
Shenzhen Carewell EIectronics
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
16 others
IIa
93/42
EUDAMED record
Report an error
Welch Allyn FDA
EU representative : Welch Allyn Limited (Ireland)
United States
16 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Biocare FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
15 others
IIa, IIb
MDR, 93/42
regulation@biocare.com.cn
EUDAMED record
Report an error
Dong Guan City Good Health Electronic Technology FDA
EU representative : Share info GmbH (Germany)
China
15 others
IIa
93/42
EUDAMED record
Report an error
Mediana FDA
EU representative : Obelis s.a. (Belgium)
South Korea
15 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Shenzhen Changkun Technology FDA
EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany)
China
15 others
IIa
93/42
EUDAMED record
Report an error
Sterifast
Portugal
15 others
IIb
93/42
Website
EUDAMED record
Report an error
Ambu FDA
Denmark
14 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Capenergy FDA
Spain
14 others
IIa, IIb
MDR, 93/42
Website
info@capenergy.com
EUDAMED record
Report an error
CICO
Italy
14 others
IIa
93/42
EUDAMED record
Report an error
Fisiopress
Italy
14 others
IIa
MDR, 93/42
info@fisiopress.com
EUDAMED record
Report an error
gbo Medizintechnik FDA
Germany
14 others
IIa
MDR, 93/42
info@gbo-ag.de
EUDAMED record
Report an error
GE Medical Systems Information Technologies FDA
EU representative : GE Medical Systems SCS (France)
United States
14 others
IIa, IIb
MDR
eudamed@gehealthcare.com
EUDAMED record
Report an error
Hygeamed FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
14 others
IIa, IIb
MDR, 93/42
Website
service@hygeamed.com
EUDAMED record
Report an error
Laborie FDA
EU representative : Medical Measurement Systems B.V. (Netherlands)
United States
14 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Lumenis FDA
EU representative : Boston Scientific Limited (Ireland) and 1 other
Germany, Israel
14 others
IIb
MDR
Website
eudamed@bsci.com
EUDAMED record
Report an error
Mectronic Medicale FDA
Italy
14 others
IIa, IIb
MDR, 93/42
info@mecmedix.com
EUDAMED record
Report an error
Mediland
EU representative : Luana Med. B.V. (Netherlands)
China, Taiwan
14 others
I
MDR
EUDAMED record
Report an error
Nouvag FDA
EU representative : Nouvag GmbH (Germany)
Switzerland
14 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
NWT
Germany
14 others
IIa
93/42
Website
info@nwt.care
EUDAMED record
Report an error
PRIM FDA
Spain
14 others
I, IIa, IIb
MDR
Website
eudamed1@prim.es
EUDAMED record
Report an error
Shanghai Kohden Medical Electronic Instrument
EU representative : NIHON KOHDEN EUROPE GmbH (Germany)
China
14 others
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Shenyang Shenda Endoscope FDA
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
14 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen Aeon Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
14 others Compressor Nebulizer A500LW05 93/42 Compressor Nebulizer A500LW06 93/42 Compressor Nebulizer A500LW07 93/42 Compressor Nebulizer A500LW08 93/42 Compressor Nebulizer A500LW09 93/42 Compressor Nebulizer A500LW10 93/42 Compressor Nebulizer A500LW11 93/42 Compressor Nebulizer A500LW12 93/42 Compressor Nebulizer A500LWD 93/42 Compressor Nebulizer A500LWD01, A500LWD02, A500LWD04, A500LWD05, A500LWDC01, A500LWDC02, A500LWDC04, A500LWDC05 3 refs ECG RECORDER HeartPATCH-BT Pulse Oximeter A300, A310, A320, A330, A340, A310L, A340L 3 refs Pulse Oximeter A310 93/42 TENS/EMS UnIT A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W 3 refs
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shenzhen Witleaf Medical Electronics FDA
EU representative : Zug Medical Systems (France)
China
14 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Sifary FDA
EU representative : Caretechion GmbH (Germany)
China
14 others
I, IIa
MDR, 93/42
Website
info@sifary.com
EUDAMED record
Report an error
Suzhou Kangjie Medical FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
14 others
I
MDR
EUDAMED record
Report an error
Weyer
Germany
14 others
IIa, IIb
93/42
Website
info@weyermed.com
EUDAMED record
Report an error
Datex-Ohmeda FDA
EU representative : GE Healthcare Finland Oy (Finland) and 1 other
United States
14 others
I, IIa, IIb
MDR, 93/42
eudamed@gehealthcare.com
EUDAMED record
Report an error
3S Ortho
France
13 others
IIa
93/42
contact@3sortho.com
EUDAMED record
Report an error
Atom Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
13 others BILI-THERAPY Spot Type Stand Type 93/42 Dual lncu I w/ O2 Controller Unit, AC230V Dual Incu i w/O2 Controller Unit 93/42 Dual lncu I w/o O2 Controller Unit, AC230V Dual Incu i w/o O2 Controller Unit 93/42 Incu I Main Unit Only,w/ O2 Controller, AC230V Incu i w/O2 Controller Unit, Main unit 93/42 Incu I Main Unit Only,w/o O2 Controller, AC230V Incu i w/o O2 Controller Unit, Main unit 93/42 Incu I w/ O2 Controller Unit, AC230V 93/42 IncuArch 93/42 InfaLite Sunflower Warmer Cabinet/Tilt, AC230V 93/42 Sunflower Warmer Hi-Low/Tilt, AC230V 93/42 Sunflower Warmer Stand, AC230V 93/42 Sunflower Warmer Wall Mount, AC230V 93/42 Z12080407 93/42
I, IIa, IIb
MDR, 93/42
Website
infoEU@atomed.co.jp
EUDAMED record
Report an error
Avatajhiz
EU representative : Heiltronic (Germany)
Iran
13 others
I, IIb
MDR
Website
EUDAMED record
Report an error
Bonss Medical Technology
EU representative : Obelis s.a. (Belgium) and 2 others
China
BONSS ES-HD1、ES-HD2、ES-4K1、ES-4K2、TS-HD1、TS-HD2、LS-HD1、LS-HD2、ETS-HD1、ETS-HD2 BONSS HC-A45, HC-A05, HC-A55, HC-A06, HC-A65, HC-A07, HC-A75, HC-A09, HC-A10, HC-A12, HC-A13, HC-A14, HC-A15, HC-A16, HC-A21, HC-A26 BONSS HC-B45, HC-B05, HC-B55, HC-B06, HC-B65, HC-B07, HC-B75, HC-B09, HC-B10, HC-B12, HC-B13, HC-B14, HC-B15, HC-B16, HC-B21, HC-B26 BONSS HC-E01 BONSS HC-G01, HC-G02, HC-G03 13 others
I, IIa, IIb
MDR, 93/42
sales@plasma-surgical.com
EUDAMED record
Report an error
Cefla FDA
Italy
13 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Cosmed FDA
EU representative : Advena Limited (Malta)
France, Italy, United States
13 others
I, IIa
MDR
Website
regulatory@cosmed.com
EUDAMED record
Report an error
Davidhealth FDA
Finland
13 others
I
93/42
info@davidhealth.com
EUDAMED record
Report an error
Hoffrichter
Germany
13 others
IIa
93/42
Website
info@hoffrichter.de
EUDAMED record
Report an error
Lid - Sotramet
France
13 others
I
MDR
Website
direction@lid-lamps.com
EUDAMED record
Report an error
Rfxcare FDA
EU representative : RFX+Care International A/S (Denmark)
China
13 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shandong Huamei Technology FDA
EU representative : Tech4beauty GmbH (Germany)
China
13 others
IIb
93/42
EUDAMED record
Report an error
Shanghai Berry Electronic Tech FDA
EU representative : Prolinx GmbH (Germany)
China
13 others
IIa
93/42
Radepartment@shberrymed.com
EUDAMED record
Report an error
Shenzhen Med-link Electronics Tech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
13 others
I, IIa, IIb
MDR, 93/42
Website
sales@med-linket.com
EUDAMED record
Report an error
Comdek
EU representative : MedNet EC-REP IIb GmbH (Germany)
Taiwan
31 others
IIb
93/42
info@comdek.com
EUDAMED record
Report an error
Shenzhen Bsx Technology Electronics FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
13 others BSX315 93/42 BSX322 93/42 BSX325 93/42 BSX513 93/42 BSX516 93/42 BSX525 93/42 BSX558 93/42 BSX561,BSX593,BSX505,BSX508,BSX527,BSX595,BSX553,BSX516,BSX515,BSX525,BSX512,BSX556,BSX595E,BSX568 BSX579 93/42 BSX583 93/42 BSXIN BSX579 93/42 BSXIN BSX595 93/42 Arm Type Electronic Blood Pressure Monitor BSX-513 93/42 (no longer marketed)
IIa
MDR, 93/42
EUDAMED record
Report an error
Aohua
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
12 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Astar
Poland
12 others
IIa, IIb
MDR
Website
eudamed@astar.eu
EUDAMED record
Report an error
Bistos FDA
EU representative : Obelis s.a. (Belgium)
South Korea
12 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Brasselerusa FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
12 others
IIa
93/42
Website
EUDAMED record
Report an error
Chongqing Kanghuaruiming Science Technology-
EU representative : Kingsmead Service B.V. (Netherlands)
China
12 others
I
MDR
EUDAMED record
Report an error
Dexther
France
12 others
I
MDR
Website
EUDAMED record
Report an error
Dmed FDA
Italy
12 others
I
MDR
Website
EUDAMED record
Report an error
Guangzhou Aquila Precise Tools FDA
EU representative : MDSS GmbH (Germany)
China
12 others
IIa
93/42
EUDAMED record
Report an error
Guangzhou Red Pine Medical Instrument FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
12 others RP-IPD-V2000EF RP-U-C0101 RP-U-C0202, RP-U-C0202S 2 refs RP-U-C03R9, RP-U-C03S9, RP-U-C03R3, RP-U-C03S3, RP-U-C04R9, RP-U-C04S9, RP-U-C04R3, RP-U-C04S3, RP-U-C06R9, RP-U-C06S9, RP-U-C06R3, RP-U-C06S3, RP-U-C06BR9, RP-U-C06BS9, RP-U-C06BR3, RP-U-C06BS3 3 refs RP-U-C0410 Single-Use Video Flexible Choledochoscope RP-H-C21 Single-Use Video Flexible Cysto-Nephroscope RP-U-C01F, RP-U-C01FS, RP-U-C01E, RP-U-C01ES, ASUS-HD-15R-CYS-02, ASUS-HD-15S-CYS-02 3 refs Single-Use Video Flexible Cystoscope RP-U-C0201, RP-U-C0201S 2 refs Single-Use Video Flexible Ureterorenoscope RP-U-C0306F, RP-U-C0307F, RP-U-C0306FS9, RP-U-C0307FS9 3 refs Single-Use Video Flexible Ureterorenoscope RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305B 3 refs Single-Use Video Gastroscope RP-GI-G02A, RP-GI-G02B 2 refs Single-Use Video Hysteroscope RP-G-C24, RP-G-C0101, RP-G-C0101B 3 refs
I, IIa
MDR
Website
regulation@gzredpine.com
EUDAMED record
Report an error
Hawkmedical
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
12 others
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
ITD FDA
Germany
12 others
I
MDR
Website
sales@itd-cart.com
EUDAMED record
Report an error
Lisalaser FDA
Germany
12 others
IIb
93/42
Website
info@lisalaser.de
EUDAMED record
Report an error
Merit FDA
EU representative : Merit Medical Ireland Ltd (Ireland)
Singapore, United States
12 others
I, IIa
MDR, 93/42
Website
udiadmin@merit.com
EUDAMED record
Report an error
NSK Dental Italy
Italy
12 others
IIb
MDR, 93/42
EUDAMED record
Report an error
Oculus FDA
Germany
12 others
I, IIa
MDR, 93/42
Website
sales@oculus.de
EUDAMED record
Report an error
THD FDA
Italy
12 others
I, IIa, III
MDR
regulatory@thdlab.com
EUDAMED record
Report an error
THOR Photomedicine FDA
EU representative : THOR Photomedicine EU Limited (Ireland)
United Kingdom (ex Northern Ireland)
12 others
IIa, IIb
MDR, 93/42
Website
qa@thorlaser.com
EUDAMED record
Report an error
A.M.I. Italia FDA
Italy
11 others
IIb
93/42
Website
info@amiitalia.com
EUDAMED record
Report an error
Aesculap FDA
Germany
11 others
I, IIa, IIb, III
MDR, 93/42
Website
eudamed@bbraun.com
EUDAMED record
Report an error
Andon Health FDA
EU representative : iHealthLabs Europe SAS (France)
China
11 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Asclepion FDA
Germany
11 others
IIb
MDR, 93/42
info@asclepion.com
EUDAMED record
Report an error
AViTA FDA
EU representative : MDSS GmbH (Germany)
Taiwan
11 others
IIa
MDR, 93/42
Website
Info@avita.com.tw
EUDAMED record
Report an error
Baxter FDA
EU representative : Baxter Deutschland GmbH (Germany)
Germany, Switzerland
11 others
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Cryoconcepts FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
11 others
IIa
93/42
Website
EUDAMED record
Report an error
Ecgmac
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
11 others
IIa
93/42
EUDAMED record
Report an error
Emtel
Poland
11 others
IIb
93/42
Website
EUDAMED record
Report an error
Grandway FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
11 others
IIa
MDR, 93/42
Website
sales@grandway.com.hk
EUDAMED record
Report an error
Guilin Refine Medical Instrument FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
Air Polishing Handpiece XP-1, XP-2 2 refs Apex Locator A7 Built-in Ultrasonic Scaler N6000, N6000L, V6000, V6000L 3 refs Curing Light MaxCure9, MaxCure3, MaxCure5, MaxCure7, MaxCureG, MaxCureH, SWAN, A-Cure, A-Cure Plus, SWAN+ 3 refs Dental Scaler PT X 11 others HP-3H 93/42 HS-7L 93/42 Powder Jet Scaler iJet, iJet S, IJet 2S 3 refs Ultrasonic Scaler Handpiece HP-3H, HP-5L, HS-7H, HS-7L, HY-2L 3 refs Ultrasonic Scaler M1, MS1, M2, MS2, M2+, MS2+, M3, MS3, MS3+, M3+, MS3S, M3S 3 refs Ultrasonic Scaler M7+, MS7+ 2 refs Ultrasonic Scaler MaxPiezo1, DS1, MaxPiezo2, MaxPiezo2+, DS2, DS2+, MaxPiezo3, MaxPiezo3+, DS3, DS3+, MaxPiezo5, MaxPiezo5+, DS5, DS5+, MaxPiezo6, MaxPiezo6+, DS6, DS6+, MaxPiezo7, MaxPiezo7+, DS7, DS7+ 3 refs Ultrasonic Scaler N2000, N2000L, N3000, N3000L, V2000, V2000L, V3000, V3000L 3 refs Ultrasonic Scaler PT 6, PT6 PRO 2 refs Ultrasonic Scaler PT 7, PT 9 2 refs Ultrasonic Scaler W1, WS1, W3, WS3, W3+, WS3+ 3 refs
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Insighters FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Electronic Nasopharyngeal Endoscope iS-HNF32, iS-HNF45, iS-HNC42, iS-HNC49, iS-HNC56, iS-HNF32L, iS-HNF45L, iS-HNC42L, iS-HNC49L, iS-HNC56L Electronic Nasopharyngeal Endoscope iS-QNF20, iS-QNF30, iS-QNF36, iS-QNC30, iS-QNC37, iS-QNC40, iS-QNC49, iS-QNF20L, iS-QNF30L, iS-QNF36L, iS-QNC30L, iS-QNC37L, iS-QNC40L, iS-QNC49L Insight Workstation iS-PF1, iS-PF2 2 refs Video Laryngoscope Accessories insight iS6 Video laryngoscope insight iS2 11 others
I
MDR, 93/42
Website
EUDAMED record
Report an error
Intuitive Surgical FDA
EU representative : Intuitive Surgical SAS (France)
United States
11 others
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Medica
Italy
11 others
I, IIb
MDR
Website
EUDAMED record
Report an error
Meditrina FDA
EU representative : Advena Limited (Malta)
United States
11 others
I, IIa, IIb
MDR
EUDAMED record
Report an error
Mercury Produzione
Italy
11 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Penlon FDA
EU representative : Obelis s.a. (Belgium)
United Kingdom (ex Northern Ireland)
11 others
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Schoelly FDA
Germany
11 others
I, IIa, III
MDR
Website
info@schoelly.de
EUDAMED record
Report an error
Unbescheiden
Germany
11 others
I, IIa
MDR, 93/42
Website
info@unbescheiden.com
EUDAMED record
Report an error
Xiamen Senyang FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
11 others
IIa
93/42
EUDAMED record
Report an error
Yamind
EU representative : Llins Service & Consulting GmbH (Germany)
China
DM28-20C-G, DM28-20A-W, DM28-20A-WP, DM28-20S-G, DM28-20SA-G, DM28-20ST-G, DM28-25S-B, DM28-25SA-BP, DM28-25ST-BP, DM28-30ST-B, DM28-30ST-BP, DM28-30STA-BP Sleep Apnoea Breathing Therapy Devices(BiPAP Devices) DM28-25S-B 93/42 Yamind DM26-20A 93/42 Yamind DM26-20C 93/42 Yamind DM26-25S 93/42 11 others
IIa
MDR, 93/42
EUDAMED record
Report an error
Parkell FDA
EU representative : Directa AB (Sweden)
United States
28 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Synthes FDA
EU representative : DePuy Ireland UC (Ireland)
Switzerland
22 others
IIa
MDR, 93/42
Website
EUDAMED_Enquiries@its.jnj.com
EUDAMED record
Report an error
Joimax FDA
Germany
14 others
I, IIa, IIb
MDR, 93/42
Website
quality@joimax.com
EUDAMED record
Report an error
Idmed FDA
France
11 others
I, IIa
MDR
info@idmed.fr
EUDAMED record
Report an error
3A Health Care
Italy
10 others
IIa, IIb
93/42
info_omronhealthcare@omron.com
EUDAMED record
Report an error
Alltion FDA
EU representative : Obelis s.a. (Belgium)
China
10 others
I
MDR
Website
sales@alltion.com
EUDAMED record
Report an error
Antoni Carles FDA
Spain
10 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Barotek Tibbi Malzeme Medikal Urunler Sualti Dalis Ekipmanlari San Ve Tic Sti
Türkiye
10 others
IIb
93/42
Website
info@barotech.com.tr
EUDAMED record
Report an error
BEMER Int FDA
Liechtenstein
10 others
IIa
MDR, 93/42
Website
regulatory@bemergroup.com
EUDAMED record
Report an error
Caireinc FDA
EU representative : MPS Medical Product Service GmbH (Germany)
United States
10 others
IIa
93/42
Website
EUDAMED record
Report an error
Daiwha
EU representative : mdi Europa GmbH (Germany)
South Korea
10 others
IIb
93/42
Website
info@daiwha.com
EUDAMED record
Report an error
Dental Tech
Italy
10 others
IIa
93/42
Website
info@dental-tech.it
EUDAMED record
Report an error
Famed
Poland
10 others
I
MDR
Website
info@famed.pl
EUDAMED record
Report an error
Hugemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
BR-M58,BR-M52,BR-M50,BR-M40,BR-M32,BR-M25,BR-M22,BR-M58H,BR-M52H,BR-M40H 3 refs CH-M52,CH-M52H 2 refs CY-M52,CY-M50,CY-M40,CY-M32,CY-M52H,CY-M40H 3 refs HT2,HT3,HT4,HT M3,HT M4,HT P2,HT ML0 3 refs HU32 10 others HugeMed CL-A、CL-B 2 refs HugeMed HU30,HU30S,HU30M 2 refs HugeMed HUV-02 HugeMed HY-45A, HY-45B, HY-50A, HY-50B 3 refs HugeMed MS-8 HugeMed VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CT 3 refs HugeMed VLM-02,VLM-03 2 refs HUV-01 MAC 1,MAC 2,MAC 3,MAC 4,MAC 5,MILLER 00,MILLER 0,MILLER 1,MAC D1,MAC D2,MAC D3,MAC D4,MAC D5 3 refs MT-01,MT-02 2 refs
I, IIa
MDR
EUDAMED record
Report an error
IntroMedic FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
10 others
IIa
93/42
Website
EUDAMED record
Report an error
Labtech
Hungary
10 others
IIa
MDR, 93/42
Website
info@labtech.hu
EUDAMED record
Report an error
Lansinoh FDA
Türkiye
10 others
IIa
MDR, 93/42
infolmd@lansinoh.com.tr
EUDAMED record
Report an error
medical ECONET
Germany
10 others
IIa, IIb
MDR, 93/42
Website
info@medical-econet.com
EUDAMED record
Report an error
Microport FDA
EU representative : MicroPort Medical B.V. (Netherlands)
China, Italy
10 others DFVision EVP-G2 DFVision EVPF-G2 HookUp Smart MVP-100B RC013 ECG cables 3 refs SkyWalker Total Knee System OSR-1100 SMART ECG SpiderFlash single use bag 3 refs Toumai EL824/30°,EL824/0°,ELW824/30° 3 refs Toumai MT-1000, MT-1000SE,VSS820,MSS810,MVS828,SSS800,12100219,12200010,VSS850,TSP8S0,TSA8C0 3 refs
I, IIa, IIb
MDR, 93/42
Website
customerservice-U@microport.com
EUDAMED record
Report an error
Optomic FDA
Spain
10 others
I, IIa
MDR
Website
prrc@optomic.com
EUDAMED record
Report an error
Rewise Tech
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
10 others
I
MDR
EUDAMED record
Report an error
Sibel Sau
Spain
10 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Technolas Perfect Vision FDA
Germany
10 others
IIa, IIb
MDR, 93/42
Website
info@technolaspv.com
EUDAMED record
Report an error
Tuyoumedical FDA
EU representative : WISELINK MEDICAL, S.L.U. (Spain)
China
10 others
I
MDR
Website
info@sztuyou.com
EUDAMED record
Report an error
electroCore FDA
EU representative : MDSS GmbH (Germany)
United States
14 others
IIa
MDR, 93/42
Website
info@electrocore.com
EUDAMED record
Report an error
Mizuho FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
10 others Operating Table 6702 HERCULES MOT-6702, 6702X, 6702 HERCULES 3 refs Operating Table ELITE 6302 MOT-6302, MOT-6302X, ELITE 6302 3 refs Operating Table MOS-1302B 3 refs Operating Table MOT-3602 MOT-3602, MOT-3602X 3 refs Operating Table MOT-5602BW 3 refs Operating Table MST-7300B, Operating Table MST-7300BX 3 refs Operating Table MST-7300BX-MR-T Intraoperative Diagnostic Operating Table System, Operating Table MST-7300BX-MR-NP Intraoperative Diagnostic Operating Table System, Operating Table MST-7300BX-MR-N Intraoperative Diagnostic Operating Table System 3 refs Operating Table VACB-3006B, Operating Table VACB-3006B Type150S, 3008 Clarity 3 refs Universal Operating Table SPL-331 Model SPL-331 Universal Operating Table Operating Table MOT-3502 MOT-3502, MOT-3502X 3 refs (no longer marketed)
I
MDR
regulatory@mizuho.co.jp
EUDAMED record
Report an error
4Well Project
Italy
9 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Altatec FDA
Germany
9 others
IIa
MDR
Website
raphael.brausch@altatec.de
EUDAMED record
Report an error
Anhui Youtak Medical Technology
EU representative : Kingsmead Service B.V. (Netherlands)
China
9 others
I
MDR
EUDAMED record
Report an error
Bbraun FDA
Germany
9 others
I, IIa, IIb
MDR
Website
eudamed@bbraun.com
EUDAMED record
Report an error
Canespa FDA
Italy
9 others
IIb
MDR
Website
quality@canespa.it
EUDAMED record
Report an error
Diers FDA
Germany
9 others
I
MDR
Website
EUDAMED record
Report an error
Firefly Global FDA
EU representative : MDSS GmbH (Germany)
United States
9 others
I
MDR
Website
sales@fireflyglobal.com
EUDAMED record
Report an error
GS Elektromedizinische Geräte G. Stemple
Germany
9 others
I, IIb
MDR, 93/42
regulatory@corpuls.com
EUDAMED record
Report an error
Hedymed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
9 others
IIb
93/42
Website
EUDAMED record
Report an error
Interacoustics FDA
Denmark
9 others
IIa
MDR
Website
info@interacoustics.com
EUDAMED record
Report an error
Lifeaz
France
9 others
IIb, III
MDR, 93/42
regulatory@lifeaz.fr
EUDAMED record
Report an error
Mediprema
France
9 others
IIa, IIb
93/42
qualite@mediprema.com
EUDAMED record
Report an error
Medline FDA
EU representative : Medline International France (France)
United States
9 others
IIa
93/42
EUDAMED record
Report an error
Nopa FDA
Germany
9 others
I, IIa
MDR
Website
info@nopa.de
EUDAMED record
Report an error
Phoenix Medical Systems
EU representative : Obelis s.a. (Belgium)
India
9 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Reha Fund
Poland
9 others
I
MDR
Website
EUDAMED record
Report an error
Saeyang FDA
EU representative : Marathon Italia S.R.L. (Italy)
South Korea
9 others
IIa
93/42
Website
EUDAMED record
Report an error
Shenzhen Unicare Electronic
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
9 others
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Sterisets
Portugal
9 others
I, IIa
93/42
Website
info@sterisets.com
EUDAMED record
Report an error
Teknomar
Türkiye
9 others
IIa, IIb
MDR, 93/42
Website
info@teknomar.com.tr
EUDAMED record
Report an error
VBM Medizintechnik FDA
Germany
9 others
I, IIa
MDR
Website
info@vbm-medical.de
EUDAMED record
Report an error
Og Wellness Technologies Headquarters
EU representative : Emergo Europe B.V. (Netherlands)
Japan
19 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Wisap
Germany
12 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
HEYER Medical
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
9 others
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Maico FDA
Germany
9 others
IIa
MDR
Website
info@maico.biz
EUDAMED record
Report an error
Ambulanc (Shenzhen) Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
8 others
I, IIa, IIb, III
MDR, 93/42
Website
info@amoulmed.com
EUDAMED record
Report an error
Amplivox FDA
EU representative : DGS Diagnostics A/S (Denmark)
United Kingdom (ex Northern Ireland)
8 others
IIa
MDR
Website
info@amplivox.com
EUDAMED record
Report an error
Antar
Poland
8 others
I
MDR
Website
EUDAMED record
Report an error
BioPhotas FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
8 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Boston Scientific FDA
EU representative : Boston Scientific Limited (Ireland)
United States
8 others
I, IIa, IIb
MDR, 93/42
Website
eudamed@bsci.com
EUDAMED record
Report an error
Cardinalhealth FDA
EU representative : Cardinal Health Ireland Manufacturing Limited (Ireland)
United States
8 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Dermadry FDA
EU representative : CEpartner4U (Netherlands)
Canada
8 others
I, IIa
MDR, 93/42
Website
support@dermadry.com
EUDAMED record
Report an error
Dexcom FDA
EU representative : MDSS GmbH (Germany)
United States
8 others
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Dreisam (Beijing) Medical Technology
EU representative : Firsteck Bio Srl. (Italy)
China
8 others
IIb
MDR
EUDAMED record
Report an error
DWA Dialyse Wasser Aufbereitungsanlagen
Germany
8 others
IIa, IIb
MDR, 93/42
Website
info@dwa-online.com
EUDAMED record
Report an error
Iboolo FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
8 others
I
MDR
EUDAMED record
Report an error
J. Morita Mfg FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Japan
8 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
JMS- Indústria de Mobiliário Hospitalar
Portugal
8 others
I
MDR
Website
EUDAMED record
Report an error
Micro Instrument
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
8 others
I
MDR
Website
info@mikoindia.com
EUDAMED record
Report an error
Ningbo Haishu Life Medical Technology
EU representative : Caretechion GmbH (Germany)
China
8 others
IIb
93/42
EUDAMED record
Report an error
Pooyandegan rah saadat
EU representative : Trionara Technologies AB (Sweden)
Iran
8 others
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Rajimp
EU representative : CS Active (Latvia)
Pakistan
8 others
I
MDR
info@rajimp.com
EUDAMED record
Report an error
Shantou Easywell Electronic Technologies
EU representative : SUNGO Europe B.V. (Netherlands)
China
8 others EASYVISTAR KS-ELS100A EASYVISTAR KS-ELS200A EASYWELL KS-200、KS-2020、KS-Q10-03A、KS-Q10-03LB、KS-Q10-03C、KS-Q10-03W、KS-Q10-02A、KS-Q10-02B、KS-Q10-02LB、KS-Q10-02C、KS-Q10-02W、KS-Q10-02R、KS-1088、KS-1088U 3 refs EASYWELL KS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT, 3 refs EASYWELL KS-7050、KS-7070、KS-5050、KS-700、KS-500 3 refs EASYWELL KS-F0503,KS-F0505,KS-F0303,KS-F05,KS-F03,KS-3030,KS-300 3 refs EASYWELL KS-Q5,KS-Q5-3D,KS-Q5-3S,KS-Q5-3B,KS-Q5N,KS-Q5N-3D,KS-Q5N-3S,KS-Q5N-3B,KS-RE01,KS-RE01-3D,KS-RE01-3S,KS-RE01-3B,KS-Q3,KS-Q3D,KS-Q3S,KS-Q3B,KS-Q35,KS-Q50,KS-ID 3 refs EASYWELL KS-Q7-02C,KS-Q7-02A,KS-Q7-02LB,KS-Q7-02W,KS-Q7-02R,KS-Q7,KS-Q7LB,KS-Q7E,KS-Q6,KS-Q6LB,KS-Q6D,KS-Q6S,KS-Q6B,KS-LA-6D,KS-LA-6S,KS-LA-6B, 3 refs
I
MDR
EUDAMED record
Report an error
Shinva FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
8 others Flexible Endoscope Washer-disinfector Rider60A,Rider60B,Rider50A,Rider50B,Rider40B,Rider30B 3 refs H2O2 Low Temperature Plasma Sterilizer PS-40X,PS-100X,PS-100XP,PS-100GXP,PS-150X,GS-100X 3 refs Low Temperature Steam-Formaldehyde Sterilizer FS-130，FS-M130，FS-K130，FS-M220，FS-L130 3 refs Operating Table STable-H7000, STable-H8500, STable H8500R, XHT-B, XHT-C ,XHT-D，XHT-D-U and XHT-F 3 refs Pulse Vacuum Sterilizer XG1.U,MAST-A,MAST-H,MAST-C,MAST-V,Clean VS 3 refs Rapid Automatic Washer-Disinfector Rapid-A-520, Rapid-M-320 ,Victor6000,Smart-L,Smart-T 3 refs Surgical Light SMart-L40plus; SMart-L35plus; SMart-R40plus; SMart-L80plus/L70plusSMart-L80plusSMart-L70plusSMart-L40plus/L35plusSMart-M35plus; SMart-M35. 3 refs Ultrasonic Washer CS-90-T,CS-90,CS-90-TA,CS-90-A,CS-80,CS-50,CS-30,CS-30-T,CS-10,CS-10-T 3 refs
I, IIa
MDR
EUDAMED record
Report an error
Suntem
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
8 others
IIa
93/42
EUDAMED record
Report an error
Suzhou Semorr Medical Technology FDA
EU representative : MedPath GmbH (Germany)
China
8 others
I
MDR
ra.semorr@bondent.com
EUDAMED record
Report an error
Ardo medical FDA
EU representative : ARDO medical GmbH (Germany)
Switzerland
9 others
IIa
MDR, 93/42
Website
info@ardo.ch
EUDAMED record
Report an error
Augmedical
Poland
7 others
I
MDR
Website
info@augmedical.pl
EUDAMED record
Report an error
B.A. International
EU representative : CB Healthcare Consulting GmbH (Germany)
United Kingdom (ex Northern Ireland)
7 others
I, IIa
MDR, 93/42
Website
info@bainternational.com
EUDAMED record
Report an error
Being Technology
EU representative : phoenix Medtech GmbH (Germany)
China
7 others
IIa, IIb
93/42
EUDAMED record
Report an error
Besdatatech FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
E-pocket(E-monitor and Scopes) VOT-1000(E-monitor);VRN-1010,VRN-1020,VRN-1030, VRN-1040,VRN-1050,VRN-1060,VRN-1080,VRN-1090, OTT-1010,VFL-1010,VRN-102S, VRN-104S,VRN-101R, VRN-105R(Scopes) 3 refs Flexible Video Rhinolaryngoscope RL-D1,RL-F1,RL-F2,RL-F3,EN-BR001,EN-BR002,EN-BR003,EN-BR004,EN-BR005,EN-BR006,EN-BR007,EN-BR008,EN-BR009,EN-BR010,RL-BS008,RL-BS009,RL-BS010,RL-BS011 3 refs Image Processor MIP1001,MIP1002,MIP1003,BD-M7,MIP-B0124,MIP1000, Advanced DUO 3 refs Single use flexible bronchoscope BR-D1,BR-D2,BR-D3,BR-D4,BR-F1,BR-F2,BR-F3,BR-F4,BR-F6,BR-F7,BR-F8,BR-F9,BR-F10 3 refs Single use flexible choledochoscope CH-D1,CH-F1 2 refs 7 others Single use flexible cystoscope CY-D1,CY-F1,CY-F2,CY-F3 3 refs Single use flexible rhinolaryngoscope RL-BS003,RL-BS004,RL-BS005,RL-BS006,RL-BS007,RL-BS015,RL-BS016,RL-BS017,RL-BS018,RL-BS019 3 refs Single use flexible ureteroscope UR-D1,UR-D2,UR-F1,UR-F2,UR-F3,UR-F4,UR-F5,UR-F6,UR-F8,UR-F9 3 refs Single use hysteroscope HY-H1,HY-H2,HY-G1,HY-G2,HY-H3,HY-H4,HY-H5,HY-H6,HY-H7 3 refs Sinuscope SE-BR001 Video Laryngoscope BD-DF 3 refs Video otoscope VOT-01,VOT-02,VRN-01,VRN-02,NX-01,OT-BR001,OT-BR002,OT-BR003 3 refs
I, IIa
MDR
support@besdatatech.com
EUDAMED record
Report an error
CAO Group FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
7 others
I
MDR
Website
info@caogroup.com
EUDAMED record
Report an error
Chongqing RuiYu Instrument Equipment
EU representative : Kingsmead Service B.V. (Netherlands)
China
7 others
I
MDR
EUDAMED record
Report an error
Eaglenos FDA
EU representative : MedPath GmbH (Germany)
China
7 others
IIb
MDR
EUDAMED record
Report an error
Foshan Gladent Medical Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
China
7 others
IIa
93/42
EUDAMED record
Report an error
Gentherm FDA
EU representative : AR Experts B.V. (Netherlands)
United States
7 others
IIb
93/42
Website
EUDAMED record
Report an error
Hunan Beyond Medical Technology FDA
EU representative : MedPath GmbH (Germany) and 1 other
China
7 others
IIa, IIb
MDR, 93/42
Website
sale@csbeyond.com
EUDAMED record
Report an error
Huvitz FDA
EU representative : MDSS GmbH (Germany)
South Korea
HRK-9000A, HRK-8100A, HRK-8000A, HRK-7000A, HRK-1, HRK-7000, ERK-9100 3 refs HRT-7000, CIT-4000 2 refs HS-5000, HS-5000(X2), HS-5000(X3), HS-5500, HS-7000, HS-7500 and HIS-5000U 2 refs HUVITZ HBM-1 HUVITZ HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF 3 refs 7 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Inventis FDA
Italy
7 others
I, IIa
MDR
Website
quality@inventis.it
EUDAMED record
Report an error
Kavo FDA
Germany
7 others
I, IIa
MDR
Website
info@kavo.com
EUDAMED record
Report an error
MediThinQ FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
7 others
I
MDR
Website
info@medithinq.com
EUDAMED record
Report an error
Mediworks FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
7 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Northern Meditec
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
7 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Novanta FDA
Germany
7 others
I, IIa, IIb
MDR, 93/42
regulatory.affairs@novanta.com
EUDAMED record
Report an error
Pioon FDA
EU representative : Humiss Beratung GmbH (Germany) and 1 other
China
7 others
IIb
MDR, 93/42
info@pioon.com
EUDAMED record
Report an error
Quantel Medical FDA
France
7 others
IIa, IIb
MDR, 93/42
Website
eudamed@quantelmedical.fr
EUDAMED record
Report an error
Rolence FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Taiwan
7 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Runyes FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
7 others Ease-02 Maple 42D, Maple 42U 2 refs Maple 62D,Maple 62U 2 refs SEA23L, SEA18L，STE16L, STE12L, STE8L, CAL23L，CAL18L,CAL16L，CAL12L, CAL8L 3 refs SEA29L,CAL29L SEA45L STE5L, BES5L, CAL5L 3 refs
IIa
MDR
EUDAMED record
Report an error
Sensor Medica FDA
Italy
7 others
I
MDR
Website
info@sensormedica.com
EUDAMED record
Report an error
Shanghai Shiyin Photoelectric Instrument
EU representative : Kingsmead Service B.V. (Netherlands)
China
7 others
I
MDR
EUDAMED record
Report an error
Smeg
Italy
7 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Stihler Electronic FDA
Germany
7 others
IIb
93/42
Website
EUDAMED record
Report an error
Super Vision Optical Tech
EU representative : BioDomi GmbH (Germany)
China
7 others
IIa
MDR
EUDAMED record
Report an error
Weldoninstrument FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
Pakistan
7 others WS-511-006R: Non-Sterile, Reusable, Hartmann Tuning Fork C 128 93/42 WS-511-007R: Non-Sterile, Reusable, Hartmann Tuning Fork C1 256 93/42 WS-511-008R: Non-Sterile, Reusable, Hartmann Tuning Fork C2 512 93/42 WS-511-009R: Non-Sterile, Reusable, Hartmann Tuning Fork C3 1024 93/42 WS-511-010R: Non-Sterile, Reusable, Hartmann Tuning Fork C4 2048 93/42 WS-511-011R: Non-Sterile, Reusable, Hartmann Tuning Fork C5 4096 93/42 WS-512-012R: Non-Sterile, Reusable, Set Of Tuning Forks Hartmann C 128, C1 256, C2 512, C3 1024, C4 2048 93/42
I
93/42
Website
EUDAMED record
Report an error
Weseemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
7 others
I, IIa
MDR
info@weseemed.com
EUDAMED record
Report an error
Zenith Technical Innovations FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
7 others
I, IIa
MDR
EUDAMED record
Report an error
Zumax Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
7 others
I
MDR
sales@zumaxmedical.com
EUDAMED record
Report an error
GE Healthcare FDA
EU representative : GE Medical Systems SCS (France)
Finland, India
10 others
I, IIb
MDR, 93/42
eudamed@gehealthcare.com
EUDAMED record
Report an error
Cutera FDA
EU representative : MDSS GmbH (Germany)
United States
7 others
IIb
MDR, 93/42
Website
info@cutera.com
EUDAMED record
Report an error
PINO Pharmazeutische Präparate
Germany
7 others
I
MDR
Website
service@pinoshop.com
EUDAMED record
Report an error
A.R.C. Laser FDA
Germany
6 others
I, IIb
MDR
Website
info@arclaser.de
EUDAMED record
Report an error
Arjo FDA
Sweden
6 others
I, IIa, IIb
MDR
Website
info@arjo.com
EUDAMED record
Report an error
Benqmedicaltech FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
6 others
I
MDR
EUDAMED record
Report an error
Change Healthcare Canada FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
6 others
IIa
93/42
EUDAMED record
Report an error
Dbc
Finland
6 others
I
MDR
Website
EUDAMED record
Report an error
Dima Italia FDA
Italy
6 others
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Durable Hospital Supplies
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
Charriere Saw 26.5cm 10-1082-00 93/42 Hard case for Laryngoscope - Transparent Top with Black Bottom 47-200-16 93/42 Laryngoscope, McIntosh, set, 5 curved blades No. 00,0,1,2,3 and handle, in case 20-200-500 93/42 Laryngoscope, McIntosh, set, 5 curved blades No. 00,1,2,3,4 and handle, in case 20-200-600 93/42 Macintosh Blade fiber optic illumination set of 3 00,0,1 93/42 6 others Macintosh Blade Standard Illumination Blade Size 00 20-100-000 93/42 Macintosh Blade Standard Illumination set of 3 00,0,1 93/42 McCOY FLEXI TIP INTEGRATED LARYNGOSCOPE FIBER OPTIC SET OF 3 BLADES (Sizes 2,3,4 with handle) 93/42 MILLER LARYNGOSCOPE FIBER OPTIC SET OF 3 BLADES (Sizes 00,0,1 with handle) 20-200-15 3 refs Non-Sterile Reusable Laryngoscopes Set of 10 Miller Fiber Optic 1,2,3,4 & Macintosh Fiber Optic 1,2,3,4 with adult and child handle 93/42
I
MDR, 93/42
Website
EUDAMED record
Report an error
Endoso FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
6 others P1-A、P1-B、P1-C、P1-D、P1-E、P2-A、P2-B、P2-C、P2-D、P2-E 3 refs PCH12-1, PCH12-2, PCH12-3, PCH22-1, PCH22-2, PCH22-3, PCH22-4, PCH22-5, PCH22-6, PCH24-1, PCH24-2, PCH24-3, PCH24-4, PCH24-5, PCH24-6 3 refs PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-6 3 refs PTC-1,PTC-2,PTC-3,YTC-1,YTC-2,YTC-3,ECT-1 3 refs PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2 3 refs VLS-A
I, IIa
MDR
EUDAMED record
Report an error
EUSA Global FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United States
6 others
I
MDR
Website
EUDAMED record
Report an error
Extremity Medical FDA
EU representative : MDSS GmbH (Germany)
United States
6 others
IIa
93/42
EUDAMED record
Report an error
Flexicare FDA
EU representative : Flexicare EU Ops Ltd (Northern Ireland)
United Kingdom (ex Northern Ireland)
6 others
I, IIa
MDR, 93/42
regulatory@flexicare.com
EUDAMED record
Report an error
Foshan Joinchamp Medical Device
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Integral dental unit ZC-9200A 93/42 Integral dental unit ZC-A200 93/42 Integral dental unit ZC-A400 93/42 Integral dental unit ZC-S200, ZC-S300, ZC-S330, ZC-S430，ZC-E300, ZC-S400, ZC-S500, ZC-S730, ZC-S600, ZC-S700, ZC-S830, ZC-S800 3 refs Integral dental unit ZC-S300 93/42 6 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Haetmed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
6 others
IIb
93/42
EUDAMED record
Report an error
Hilbro Instruments FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
6 others
I
MDR
sales@hilbro-instruments.com
EUDAMED record
Report an error
Innoview FDA
Germany
6 others
I, IIa
MDR
Website
mail@innoview.info
EUDAMED record
Report an error
Integralife FDA
EU representative : Integra LifeSciences Services (France)
United States
6 others
I, IIb, III
MDR, 93/42
EUDAMED record
Report an error
Kernelmed FDA
EU representative : Caretechion GmbH (Germany)
China
6 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Kjump FDA
EU representative : Polygreen Germany GmbH (Germany)
Taiwan
6 others
IIa
93/42
Website
service@polygreen.com.tw
EUDAMED record
Report an error
Longest FDA
EU representative : Lotus NL B.V. (Netherlands) and 1 other
China
6 others
IIa
MDR, 93/42
Website
service@longest.cn
EUDAMED record
Report an error
Medikro FDA
Finland
6 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
MIR - Medical International Research FDA
Italy
6 others
IIa
MDR
Website
EUDAMED record
Report an error
MK-dent FDA
Germany
6 others
IIa
93/42
Website
info@mk-dent.com
EUDAMED record
Report an error
Ortho Cape FDA
France
6 others
IIa
93/42
Website
qualite@ortho-cape.com
EUDAMED record
Report an error
Otopront FDA
Germany
6 others
I, IIa
MDR, 93/42
Website
info@otopront.de
EUDAMED record
Report an error
Personal MedSystems
Germany
6 others
IIa
MDR
Website
EUDAMED record
Report an error
Pulmodyne
EU representative : QNET B.V. (Netherlands)
United States
6 others
IIa
93/42
EUDAMED record
Report an error
Reichert FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
6 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shandong Qufu Healthyou Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
KDC-Y KDK4，KDK5,KDK9,KDK12，KDK12/5 3 refs KDL100，KDL200，KDL300，KDL300/300,KDL450，KDL500/300，KDL-Ⅱ500/500,KDL-Ⅱ700,KDL-Ⅱ500，KDL-Ⅱ700/500，KDL-Ⅱ700/700， KDLED200,KDLED700,KDLED500,KDLED500/500，KDLED700/500,KDLED700/700,KDLED720/520，KDLED5/5，KDLED5/3，KDLED3/3，KDLED5，KDLED3， 3 refs KDT-Y08A ,KDT-Y08B ,KDT-Y09A , KDT-Y19A 3 refs 6 others
I
MDR
EUDAMED record
Report an error
Sonomed FDA
Poland
6 others
IIa
93/42
Website
EUDAMED record
Report an error
Spengler
France
6 others
I, IIa, IIb
MDR, 93/42
qualite@spengler-med.fr
EUDAMED record
Report an error
Spiegelberg FDA
Germany
6 others
IIa, III
MDR, 93/42
Website
info@spiegelberg.de
EUDAMED record
Report an error
SRA Developments FDA
EU representative : BOWA-electronic GmbH (Germany)
United Kingdom (ex Northern Ireland)
6 others
IIb
93/42
Website
EUDAMED record
Report an error
Stockert FDA
Germany
6 others
I, IIa, IIb
MDR, 93/42
Website
info@stockert.de
EUDAMED record
Report an error
TT Med
Italy
6 others
I
MDR
Website
info@ttmed.it
EUDAMED record
Report an error
Yingchitech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
6 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Zhuhai Vision Medical Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
DBC-N10,DBC-N20,DBC-N30,DBC-S10,DBC-S20,DBC-S3,0,DBC-V10, DBC-V20,DBC-V30,DBC-W10,DBC-W30,DBC-X10,DBC-X30 3 refs DCC-U10,DCC-U30,DCC-W10,DCC-W30 3 refs DUC-M10, DUC-M20, DUC-M30, DUC-N10, DUC-N30 3 refs Flexible Digital Bronchoscope BF20 3 refs Flexible Digital Cystoscope CF45 3 refs 6 others
I, IIa
MDR
service@vision-medt.com
EUDAMED record
Report an error
Lutronic FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
13 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Hemodia FDA
France
6 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Actegy FDA
EU representative : MDSS GmbH (Germany)
United Kingdom (ex Northern Ireland)
5 others
IIa
93/42
Website
info.uk@actegy.com
EUDAMED record
Report an error
Aesthetic Technology FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
5 others
IIa
93/42
qara@dermalux.com
EUDAMED record
Report an error
Alcon FDA
EU representative : Alcon Laboratories Belgium (Belgium)
United States
5 others
I, IIa, IIb
MDR, 93/42
Website
regulatory-1.operations@Alcon.com
EUDAMED record
Report an error
Alter Éco Santé
France
5 others
I
MDR
Website
contact@alterecosante.net
EUDAMED record
Report an error
BORSAM Biomedical Instruments
EU representative : Kingsmead Service B.V. (Netherlands)
China
5 others
IIa
93/42
Website
EUDAMED record
Report an error
Collin
France
5 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Dentis FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
5 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Difra FDA
Belgium
5 others
I, IIa
93/42
Website
info@difra.be
EUDAMED record
Report an error
Edgemed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
5 others
I, IIa, IIb
MDR
EUDAMED record
Report an error
ekamed
Germany
5 others
I
MDR
Website
info@ekamed.de
EUDAMED record
Report an error
Elektronika I Elektromedycyna Mlewandowski J
Poland
5 others
IIa
MDR
Website
office@eie.com.pl
EUDAMED record
Report an error
Foshan Chuangxin Medical Apparatus
EU representative : Lotus NL B.V. (Netherlands)
China
5 others
IIa
93/42
Website
EUDAMED record
Report an error
General Project FDA
Italy
5 others
IIa, IIb
93/42
Website
info@generalproject.com
EUDAMED record
Report an error
Ginevri
Italy
5 others
IIa, IIb
93/42
Website
mail@ginevri.com
EUDAMED record
Report an error
Haag-Streit UK FDA
EU representative : Haag-Streit Deutschland GmbH (Germany)
United Kingdom (ex Northern Ireland)
5 others
I, IIa
MDR, 93/42
Website
regulatoryhsuk@haag-streit.com
EUDAMED record
Report an error
Hans Dinslage
Germany
5 others
IIa
MDR
service@sanitas-online.de
EUDAMED record
Report an error
Healnoc FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
China
Camera Control Unit ECU-C410-A,ECU-C410-B Camera Control Unit ECU-M600-A, ECU-M600-A1, ECU-M600-B,ECU-M600-B1 3 refs ECH-301, ECH-301-S, ECH-301-P, ECH-302, ECH-500, ECH-502, ECH-504 3 refs ECH-F500, ECH-F502, ECH-F504 2 refs Endoscopic Camera System ECS-400; ECS-400A; ECS-400B; ECS-400C; ECS-401; ECS-410; ECS-400D 2 refs 5 others
I, IIb
MDR
ra-registration@healnoc.com
EUDAMED record
Report an error
Huger FDA
EU representative : Lotus NL B.V. (Netherlands)
China
5 others
I, IIa
MDR
Website
EUDAMED record
Report an error
INTERmedic Arfran FDA
Spain
5 others
IIb
MDR
EUDAMED record
Report an error
Juventas
Poland
5 others
I
MDR
EUDAMED record
Report an error
KW Apparecchi Scientifici
Italy
5 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Leica Microsystems (Schweiz) FDA
EU representative : Leica Microsystems CMS GmbH (Germany)
Switzerland
5 others
I, IIa
MDR
EUDAMED record
Report an error
Lightmed FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
Taiwan
5 others
IIb
93/42
Website
eudamed@lightmed.com
EUDAMED record
Report an error
MediRobotic technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
5 others
IIa
MDR
EUDAMED record
Report an error
Medlab
Germany
5 others
IIb
93/42
Website
sales@medlab.eu
EUDAMED record
Report an error
Meilan FDA
EU representative : Lotus NL B.V. (Netherlands)
China
5 others
IIa
MDR
EUDAMED record
Report an error
Microaire FDA
EU representative : MediMark Europe Sarl. (France)
United States
5 others
I, IIa
MDR
EUDAMED record
Report an error
Micromed FDA
Germany, Italy
5 others
I, IIb
MDR, 93/42
Website
info@micromed.com
EUDAMED record
Report an error
Namwiwat
EU representative : Obelis s.a. (Belgium)
Thailand
5 others
IIb
93/42
Website
EUDAMED record
Report an error
Nanjing Yanan Special Lighting Factory FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
5 others
I
MDR
Website
sales@kwslight.com
EUDAMED record
Report an error
Niceneotech
EU representative : Amstermed B.V. (Netherlands)
India
5 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
OrthoPediatrics Canada ULC
EU representative : MedEnvoy Global BV (Netherlands)
Canada
5 others
I, IIa
MDR
EUDAMED record
Report an error
PROACT Medical FDA
EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland)
United Kingdom (ex Northern Ireland)
5 others
I
MDR
Website
quality@proactmedical.co.uk
EUDAMED record
Report an error
SELVAS Healthcare FDA
EU representative : Obelis s.a. (Belgium)
South Korea
5 others
IIa
93/42
Website
info@selvashc.com
EUDAMED record
Report an error
SG Manufacturers FDA
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
5 others
I
MDR
Website
sales@sgminstruments.com
EUDAMED record
Report an error
Steelco FDA
Italy
5 others
I, IIb
MDR, 93/42
Website
info@steelcogroup.com
EUDAMED record
Report an error
Sysmed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
5 others
IIa
93/42
EUDAMED record
Report an error
Unimax Medical Systems FDA
EU representative : mdi Europa GmbH (Germany)
Taiwan
5 others
I, IIa
MDR, 93/42
Website
ra@unimaxmeds.com
EUDAMED record
Report an error
Wright Medical Technology FDA
EU representative : Stryker European Operations Limited (Ireland)
United States
5 others
I, IIa
MDR, 93/42
Website
RegulatoryAffairsTE@stryker.com
EUDAMED record
Report an error
Diagnosysllc FDA
EU representative : Diagnosys Vision Limited (Ireland)
United States
6 others
IIa
93/42
Website
mail@diagnosysllc.com
EUDAMED record
Report an error
Sentec FDA
EU representative : Sentec GmbH (Germany)
Switzerland
5 others
I
MDR
Website
info@sentec.com
EUDAMED record
Report an error
Acf
Türkiye
4 others
IIa
MDR, 93/42
Website
info@acf.com.tr
EUDAMED record
Report an error
Berger&Kraft Medical
Poland
4 others
IIa, IIb
93/42
Website
regulatory@bergerandkraft.com
EUDAMED record
Report an error
BioMed Jena
Germany
4 others
I, IIa
MDR, 93/42
Website
eudamed@biomed-jena.de
EUDAMED record
Report an error
Biomedical Instruments
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4 others BI9100 93/42 BI9800TL+ 93/42 BI9900 93/42 Holter System BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C 3 refs
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Biotech
Germany
4 others
IIa
93/42
eudamed@biotech-medical.de
EUDAMED record
Report an error
Bittium FDA
Finland
4 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
BÖSL Medizintechnik
Germany
4 others
I, IIa
MDR
Website
info@boesl-med.de
EUDAMED record
Report an error
Ca-Mi
Italy
4 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
CardioQuip FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
4 others
IIb
93/42
Website
regulatory@cardioquip.com
EUDAMED record
Report an error
Combei FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
4 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Framiral
France
4 others
I
MDR
Website
contact@framiral.fr
EUDAMED record
Report an error
Getemed FDA
Germany
4 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Getinge FDA
Sweden
4 others
I, IIa, IIb
MDR
info.disinfektion@getinge.com
EUDAMED record
Report an error
Guangzhou Life Light Electronic Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4 others
IIa
93/42
Website
info@owgels.com
EUDAMED record
Report an error
Hakomed
Italy
4 others
IIb
93/42
Website
EUDAMED record
Report an error
Health & Life
EU representative : Emergo Europe B.V. (Netherlands) and 1 other
Taiwan
4 others
IIa
93/42
Website
EUDAMED record
Report an error
Incelermedikal
Türkiye
4 others
IIb
MDR, 93/42
Website
quality@incelermedikal.com
EUDAMED record
Report an error
InMode FDA
EU representative : AR Experts B.V. (Netherlands)
Israel
4 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
InSightec FDA
EU representative : Obelis s.a. (Belgium)
Israel
4 others
I, IIb
MDR
Website
EUDAMED record
Report an error
Kinvent FDA
France
4 others
I
MDR, 93/42
Website
info@k-invent.com
EUDAMED record
Report an error
Lares Research FDA
EU representative : MDSS GmbH (Germany)
United States
4 others
IIa
93/42
Website
EUDAMED record
Report an error
Lode FDA
Netherlands
4 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Mbelec FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4 others
IIa, IIb, III
MDR, 93/42
EUDAMED record
Report an error
Medin FDA
EU representative : SIA City Screen (Latvia)
Belarus
4 others
I
MDR
Website
EUDAMED record
Report an error
Ortho Km
Sweden
4 others
I
MDR
Website
info@syntavlor.se
EUDAMED record
Report an error
Pikdare FDA
Italy
4 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
PISTON Műszaki Fejlesztő, Kereskedelmi és Ügynöki Korlátolt Felelősségű Társaság
Hungary
4 others
IIa
93/42
Website
info@pistonmedical.com
EUDAMED record
Report an error
Pulse for Integrated Solutions
Germany
4 others
IIa
93/42
Website
info@pulsegmbh.de
EUDAMED record
Report an error
Research Production Monitor
EU representative : CMC Medical Devices & Drugs SL (Spain)
Russia
4 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Rexxam FDA
EU representative : REXXAM CZECH s.r.o. (Czechia) and 1 other
Japan
4 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Snucone FDA
EU representative : MDSS GmbH (Germany)
South Korea
4 others
IIa
93/42
EUDAMED record
Report an error
Soluscope
France
4 others
I, IIb
MDR, 93/42
contact@anios.com
EUDAMED record
Report an error
Sophway FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
4 others
I, IIa
MDR
EUDAMED record
Report an error
Suntechmed FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
4 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Tianjin Fuqin Science & Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
4 others
IIa
MDR
EUDAMED record
Report an error
Unimed FDA
EU representative : Obelis s.a. (Belgium)
China, Poland
4 others
IIb
93/42
Website
info@unimed.cn
EUDAMED record
Report an error
Varian Medical Systems FDA
EU representative : Siemens Healthineers Nederland B.V. (Netherlands)
United States
4 others
IIa, IIb
MDR
EUDAMED record
Report an error
Xiamen Weiyou Intelligent Technology FDA
EU representative : Sungo Cert GmbH (Germany)
China
4 others
IIa
MDR
EUDAMED record
Report an error
Zhongke Meiling Cryogenics FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
4 others Meling Biomedical DW-HL778SA 93/42 Meling Biomedical DW-HL858SA 93/42 Ultra-Low Temperature Freezer DW-FL528, DW-FL678, DW-FL778, DW-FL1008, DW-FL528C, DW-FL678C, DW-FL778C, DW-FL1008C Ultra-Low Temperature Freezer DW-HL398, DW-HL528, DW-HL678, DW-HL778, DW-HL858, DW-HL1008, DW-HL398SA, DW-HL528SA, DW-HL678SA, DW-HL778SA, DW-HL858SA, DW-HL1008SA, DW-HL398S, DW-HL528S, DW-HL678S, DW-HL778S, DW-HL858S, DW-HL1008S, DW-HL530, DW-HL780
IIa
MDR, 93/42
EUDAMED record
Report an error
Amedus
Türkiye
8 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Breas FDA
EU representative : Breas Medical AB (Sweden)
Sweden, United Kingdom (ex Northern Ireland)
6 others
IIa, IIb
MDR, 93/42
Website
orders@nippyventilator.com
EUDAMED record
Report an error
Fotona FDA
Slovenia
4 others
IIa, IIb
MDR, 93/42
info@fotona.com
EUDAMED record
Report an error
4Fizjo
Poland
3 others
I
MDR
Website
EUDAMED record
Report an error
Appsens
Norway
3 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Biocompression FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
3 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
ChongQing SunKingdom Medical Instrument FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
3 others Ophthalmic Slit Lamp Microscope LS-1A LS-1A, LS-1B, LS-3, LS-4, LS-5, LS-5C, LS-6, LS-6C, LS-7, LS-7C, LS-7CS, LS-7CE, LS-7DS, LS-7DE, LS-8, LS-8A, LS-8C, LS-8D, LS-9, LS-9C, LS-9CS, LS-9D 3 refs Perimeter SK-950B SK-950B,SK-950C 2 refs Retinometer SK-6500A 2 refs
I, IIa
MDR, 93/42
Website
sales@cqsunkingdom.com
EUDAMED record
Report an error
Chongqing Xishan Science & Technology
EU representative : MedPath GmbH (Germany)
China
3 others
I, IIa
MDR
info@xishantech.com.cn
EUDAMED record
Report an error
Cortex FDA
Denmark
3 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Defibtech FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
3 others
IIb, III
MDR, 93/42
service@defibtech.com
EUDAMED record
Report an error
Ditron Dental FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Israel
3 others
IIa, III
93/42
Website
info@ditrondental.com
EUDAMED record
Report an error
Domino FDA
Italy
3 others
I
MDR
Website
quality@globusitalia.com
EUDAMED record
Report an error
Donga
EU representative : mdi Europa GmbH (Germany)
South Korea
3 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Espansione FDA
Italy
3 others
IIa
93/42
Website
info@espansione.it
EUDAMED record
Report an error
Essilor FDA
France
3 others
I
MDR, 93/42
Website
info@essilor.fr
EUDAMED record
Report an error
Fast Therapies
Italy
3 others
IIa
MDR
Website
info@fasttherapies.com
EUDAMED record
Report an error
Fisher & Paykel Healthcare FDA
EU representative : FISHER & PAYKEL HEALTHCARE SAS (France)
New Zealand
3 others
IIa, IIb
MDR, 93/42
Customer.CareNZ@fphcare.co.nz
EUDAMED record
Report an error
Guangdong JINME Medical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3 others
IIa
MDR, 93/42
regulatory-1@jinmedental.com
EUDAMED record
Report an error
Henry Schein FDA
EU representative : Henry Schein Services GmbH (Germany)
United States
3 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Heyer Medical
Germany
3 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Hingmed FDA
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
China
3 others
IIa
MDR, 93/42
EUDAMED record
Report an error
Hu-Friedy Manufacturing
EU representative : Hu-Friedy Europe LLC & Co. KG (Germany)
United States
3 others
I, IIa
MDR
EUDAMED record
Report an error
IceCure Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
Cryoprobe D2.4 mm/13G, 124 mm, Trocar, Spheric FAP7600000 93/42 Cryoprobe D2.4 mm/13G, 134 mm, Trocar, Elliptic FAP7800000 93/42 Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric. FAP7100000 93/42 Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic FAP7200000 93/42 Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic FAP7400000 93/42 3 others
IIa
93/42
Website
EUDAMED record
Report an error
Innow
Poland
3 others
I
MDR
marketing2@innow.pl
EUDAMED record
Report an error
Jiangxi China Medical Equipment
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3 others
I
MDR
Website
EUDAMED record
Report an error
Kare Medikal Ve Analitik Cih San Ve Tic Sti
Türkiye
3 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Kavandish
EU representative : Trionara Technologies AB (Sweden)
Iran
3 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Livanova FDA
Germany
3 others
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Machida Endoscope FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
3 others
I
MDR
Website
EUDAMED record
Report an error
Medency FDA
Italy
3 others
I
MDR
Website
info@medency.com
EUDAMED record
Report an error
Medicapteurs
France
3 others
I
MDR
Website
info@medicapteurs.fr
EUDAMED record
Report an error
MTG
Germany
3 others
IIb
93/42
Website
info@mtg-gmbh.de
EUDAMED record
Report an error
Nanjing Tuge Healthcare
EU representative : MedPath GmbH (Germany)
China
3 others
I, IIa
MDR
EUDAMED record
Report an error
Neomedlight FDA
France
3 others
I, IIa
MDR, 93/42
Website
contact@neomedlight.com
EUDAMED record
Report an error
Nidek FDA
EU representative : NIDEK SA (France)
Japan
3 others
I, IIa, IIb
MDR
EUDAMED record
Report an error
Nihon Kohden FDA
EU representative : NIHON KOHDEN EUROPE GmbH (Germany)
Japan, United States
3 others
I, IIa, IIb
MDR, 93/42
Website
information@db.nkc.co.jp
EUDAMED record
Report an error
Novafon
Germany
3 others
I, IIa
MDR
Website
info@novafon.de
EUDAMED record
Report an error
Nox Medical FDA
Iceland
3 others
IIa
MDR, 93/42
Website
support@noxmedical.com
EUDAMED record
Report an error
Raycome FDA
EU representative : Lotus NL B.V. (Netherlands)
China
3 others
IIa
MDR, 93/42
EUDAMED record
Report an error
REDA Instrumente FDA
Germany
3 others
I
MDR
Website
EUDAMED record
Report an error
Roche FDA
Germany
3 others
IIb
93/42, 98/79
Website
EUDAMED record
Report an error
SCHMITZ medical FDA
Germany
3 others
I
MDR
Website
EUDAMED record
Report an error
Sedatelec FDA
France
3 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shanghai Anqing Medical Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
China
3 others
IIa
MDR
ra_dept@anqing-sh.com
EUDAMED record
Report an error
Shenzhen Enmind Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Shenzhen Nile Biotechnology
EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany) and 1 other
China
3 others
IIa
93/42
EUDAMED record
Report an error
Shenzhen Yimi Life Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
China
Dr. Max Pulse Oximeter YM101 93/42 Fingertip Pulse Oximeter YM101, YM102, YM103, YM104, YM201, YM202, YM301, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM401, YM402, YM403, YM501, YM502, YM503, YM504, YM601, YM602, YM603 3 refs Pulse Oximeter YH01,YH02 2 refs Pulse Oximeter YM101 93/42 Pulse Oximeter YM102 93/42 3 others
IIa
MDR, 93/42
EUDAMED record
Report an error
Sirona Dental Systems FDA
Germany
3 others
I, IIa, IIb
MDR, 93/42
Website
contact@dentsplysirona.com
EUDAMED record
Report an error
Surtex Instruments FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United Kingdom (ex Northern Ireland)
3 others
I
MDR
Website
info@surtex-instruments.co.uk
EUDAMED record
Report an error
TensCare FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
3 others
IIa
MDR
Website
QA@tenscare.co.uk
EUDAMED record
Report an error
Tongye Technologies Development
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
3 others
IIa
93/42
EUDAMED record
Report an error
Vimap
Spain
3 others
I, IIa
93/42
Website
support@vimap.net
EUDAMED record
Report an error
Wuhan Gigaa Optronics Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
3 others
IIb
93/42
EUDAMED record
Report an error
Dornier FDA
Germany
10 others
IIb
MDR, 93/42
Website
eudamed@dornier.com
EUDAMED record
Report an error
Citizen
EU representative : Emergo Europe B.V. (Netherlands)
Japan
5 others
IIa
93/42
EUDAMED record
Report an error
Spacelabs Healthcare FDA
EU representative : MediMark Europe Sarl. (France)
United Kingdom (ex Northern Ireland)
3 others
I, IIa
MDR
Website
EUDAMED record
Report an error
ACUTRONIC Medical Systems
EU representative : Emergo Europe B.V. (Netherlands)
Switzerland
2 others
IIa, IIb
93/42
EUDAMED record
Report an error
Akrus FDA
Germany
2 others
I
MDR
Website
info@akrus.de
EUDAMED record
Report an error
Alegio
Italy
2 others
I
MDR
EUDAMED record
Report an error
Alleva Medical FDA
EU representative : Share info GmbH (Germany)
China
2 others
IIa
MDR
EUDAMED record
Report an error
Anhui Shiyin Photoelectric Instrument FDA
EU representative : GRZAN GROUP SL (Spain)
China
2 others
I
MDR
EUDAMED record
Report an error
Arab For Industry Trading Agencies Acita
EU representative : CMC Medical Devices & Drugs SL (Spain)
Egypt
2 others
IIa
93/42
EUDAMED record
Report an error
Baisheng Medical FDA
EU representative : Prolinx GmbH (Germany)
China
2 others
IIb
93/42
EUDAMED record
Report an error
Belgian Diagnostic
Belgium
2 others
I, IIa
93/42
InfoBeldico@beldico.be
EUDAMED record
Report an error
Besmed FDA
EU representative : Casus Europe B.V. (Netherlands) and 1 other
Taiwan
2 others
I, IIa
MDR, 93/42
Website
info@besmed.com
EUDAMED record
Report an error
Chirana
Slovakia
2 others
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Chongqing Xinfeng Medical Instruments FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
2 others
IIa
93/42
Website
EUDAMED record
Report an error
Clinimed
EU representative : ANTEX MEDI SOLUTION (Germany)
United States
2 others
I
MDR
Website
info@clinimed.us
EUDAMED record
Report an error
CooperSurgical FDA
EU representative : CooperSurgical Distribution B.V. (Netherlands) and 1 other
United States
2 others
I, IIa
MDR, 93/42
RA-CSI@coopersurgical.com
EUDAMED record
Report an error
CustoMED FDA
Germany
2 others
IIa
MDR
info@customed.de
EUDAMED record
Report an error
DEKO MedTech
Finland
2 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
DM Systems (Beijing)
EU representative : ADVANCED MEDICAL SYSTEMS SL (Spain)
China
2 others
IIa
93/42
EUDAMED record
Report an error
Elekta FDA
Sweden
2 others
I, IIa
MDR
EUDAMED record
Report an error
Energist FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
2 others
I, IIb
MDR, 93/42
Website
info@energist.com
EUDAMED record
Report an error
Eureduc
France
2 others
I, IIa
93/42
Website
info@eureduc.eu
EUDAMED record
Report an error
FIAB FDA
Italy
2 others
I, IIb, III
MDR
Website
quality@fiab.it
EUDAMED record
Report an error
G. Heinemann Medizintechnik
Germany
2 others
IIa
93/42
Website
info@heinemann-ent.de
EUDAMED record
Report an error
Guangzhou Yikang Medical Equipment Industrial FDA
EU representative : Share info GmbH (Germany)
China
2 others
IIa
MDR
EUDAMED record
Report an error
Gvpmed
Italy
2 others
IIa
93/42
Website
EUDAMED record
Report an error
Haierbiomedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
2 others
IIa
MDR
EUDAMED record
Report an error
Henke-Sass, Wolf FDA
Germany
2 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Himaging FDA
EU representative : Lotus NL B.V. (Netherlands)
China
Endoscopic video processor HDIS-1000 Single-Use Flexible Video Bronchoscope DBRS-100HLP Single-Use Flexible Video Bronchoscope DBRS2-001P, DBRS2-121P, DBRS2-221P, DBRS2-301P, DBRS2-222HP, DBRS2-302HP, DBRS2-122HP, DBRS2-223HP, DBRS2-303HP, DBRS2-123HP 3 refs Single-Use Flexible Video Cystoscope DCYS-100HLP, DCYS-100HLPR 2 refs Single-Use Flexible Video Cystoscope DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR 3 refs 2 others
I, IIa
MDR
EUDAMED record
Report an error
Human Med FDA
Germany
2 others
IIa, IIb
MDR, 93/42
Website
info@humanmed.com
EUDAMED record
Report an error
Innolcon
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
BSG22,BSG35,BSG45,OCBSG22,OCBSG35,OCBSG45 3 refs High frequency surgical equipment E21, E21-A,E21-B, BFS-01, EFS-01, MFS-01, MFS-02 3 refs High frequency surgical equipment E24 InnoGrace IBSG22/35/45, IBSGBL22/35/45,IBSGPL22/35/45, ICBSG22/35/45, ICBSGBL22/35/45,ICBSGPL22/35/45,IFBSG22/35/45, IFBSGBL22/35/45, IFBSGPL22/35/45,IFCBSG22/35/45, IFCBSGBL22/35/45, IFCBSGPL22/35/45 3 refs RSG13,RSG22,RSG35,RSG45,RBSG22,RBSG35,RBSG45 3 refs 2 others SG13,SG22.SG35,SG45,OSG13,OSG22,OSG35,OSG45,OBSG22,OBSG35,OBSG45 3 refs SS9,SS17,OSS9,OSS17 3 refs
IIb
MDR
EUDAMED record
Report an error
Jiangxi Aicare Medical Technology FDA
EU representative : Caretechion GmbH (Germany)
China
2 others
IIa
93/42
Website
EUDAMED record
Report an error
Kafgrup
Türkiye
2 others
IIb
93/42
Website
info@kafgrup.com
EUDAMED record
Report an error
Kentamed
Bulgaria
2 others
IIb
MDR, 93/42
Website
office@kentamed.com
EUDAMED record
Report an error
Koite Health
Finland
2 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Labo America
EU representative : Labomed Europe b.v. (Netherlands)
United States
Adapter for C-mount Camera 3 refs Diffuser Kit eVO 300 3 refs Labomed Prima DNT Prima ,Magna,Prima Mu 3 refs PRIMA Mu ENT Prima,Prima Mu,Prima Swift,Stella,Stella N,Prima Lite 3 refs PRIMA GN ,PRIMA C,PRIMA CS,eVA,PRIMA C plus,PRIMA swift OTS 3 refs 2 others
I
MDR
EUDAMED record
Report an error
LED FDA
Italy
2 others
IIa, IIb
MDR
Website
info@led.it
EUDAMED record
Report an error
Luxamed FDA
Germany
2 others
I
MDR
Website
info@luxamed.de
EUDAMED record
Report an error
Maquet (Suzhou)
EU representative : MAQUET GmbH (Germany)
China
2 others
I, IIa
MDR
EUDAMED record
Report an error
Medela FDA
EU representative : Medela Medizintechnik GmbH & Co. Handels KG (Germany)
Switzerland
2 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Medos International Sarl FDA
EU representative : DePuy Ireland UC (Ireland)
Switzerland
2 others
I, IIa
MDR, 93/42
Website
EUDAMED_Enquiries@its.jnj.com
EUDAMED record
Report an error
Mehrish
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
2 others
I
MDR
Website
EUDAMED record
Report an error
Miconvey FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
2 others Miconvey QUBP55 Single Use Flexible Ureteroscope EPU-7635, EPU-7640, EPU-7645, EPU-7650, EPU-7655, EPU-7660, EPU-7665, EPU-7670, EPU-7635R, EPU-7640R, EPU-7645R, EPU-7650R, EPU-7655R, EPU-7660R, EPU-7665R, EPU-7670R 3 refs
I, IIa, IIb
MDR
EUDAMED record
Report an error
Micro-Tech (Nanjing)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
2 others
I, IIa
MDR
Website
info@mtmed.com
EUDAMED record
Report an error
Mipm FDA
Germany
2 others
I, IIa, IIb
MDR
Website
info@mipm.com
EUDAMED record
Report an error
Nanosonics FDA
EU representative : Nanosonics Europe GmbH (Germany)
Australia
2 others
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Netop FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
Allergy Reliever MC-001 93/42 Allergy Reliever MC-001, MC-004, MC-008, MC-008A, MC-010C 3 refs Allergy Reliever MC-008 93/42 Cure Trio MC-310 93/42 Cure Trio MC-310(Android),MC-310(iOS), MC-310A, MC-310O, MC-310P, MC-310Q, MC-310R, MC-310S, MC-310T, MC-310U, MC-310Y, MC-310B, MC-310C, MC-310D, MC-310E, MC-310F, MC-310G, MC-310H, MC-310I, MC-310M 3 refs 2 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Ningbo Jiangbei Woson Medical Instrument
EU representative : Caretechion GmbH (Germany)
China
2 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Nuova Bn
Italy
2 others
I
MDR
Website
EUDAMED record
Report an error
Optikon 2000
Italy
2 others
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Otumed FDA
EU representative : MedNet EC-REP GmbH (Germany)
United States
Aptra OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S, 3 refs Aptra OTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01 3 refs WiScope OTU-BR01, OTU-BR02, OTU-BR03 3 refs WiScope OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330R 3 refs WiScope OTU-HY01S, OTU-HY01C, OTU-HY02S, OTU-HY02C, OTU-HY03S, OTU-HY03C, OTU-HY04S, OTU-HY04C 3 refs 2 others
I, IIa
MDR
sales@otumed.com
EUDAMED record
Report an error
Pusenmedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
BF220-312R, BF220-312S, BF220-528R, BF220-528S, PB2512A, PB4122A, PB4828A, PB5232A 3 refs Clear EVAC PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; PU630A-S, PU630A-R, PU631A-S, PU631A-R; 3 refs Eview PV220; PV300, PVX800 3 refs MDH MB5128, MB4222 3 refs MDH MC100 2 refs 2 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Qingdao Zhixing Medical Instrument FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
2 others
I
MDR
EUDAMED record
Report an error
Radianqbio
EU representative : S.B. Pharma GmbH (Germany)
South Korea
2 others
IIb
93/42
Website
sales@radianqbio.com
EUDAMED record
Report an error
Radley Scientific FDA
EU representative : endocon GmbH (Germany)
United Kingdom (ex Northern Ireland)
2 others
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Resplabs FDA
EU representative : Obelis s.a. (Belgium)
Mexico
2 others
I
MDR
EUDAMED record
Report an error
Seegen FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
CHV-100-E,CHV-100T-E,CHV-US100-H,CHV-US110-H,CHV-US100D-H,CHV-100D-E 3 refs CHV-US100J-U,CHV-US110J-U 2 refs PL-1000,PL-2000,PL-2100 3 refs UV-100-E,UV-110-E,UV-100T-E,UV-110T-E,UV-US100N-E 3 refs UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H, UV-US120-H-3U, UV-US130-H-3U, UV-US100D-H-3U 3 refs 2 others UV-US100S-H, UV-US110S-H, UV-US100TS-H, UV-US110DS-H, UV-US120DS-H, UV-US121S-H, UV-US130S-H, UV-US140S-H, UV-US150S-H 3 refs UV-US121-H, UV-US101D-H, UV-US140-H, UV-US140-H-3U, UV-US100T-H, UV-US100T-H-3U, UV-US110T-H, UV-US110T-H-3U, UV-US110D-H, UV-US110D-H-3U, UV-US150-H, UV-US150-H-3U, UV-US120D-H 3 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
Sefam
France
2 others
I, IIa
MDR, 93/42
Website
regulatoryaffairs@sefam-medical.com
EUDAMED record
Report an error
Shenzhen Dongdixin Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
2 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Skanray FDA
EU representative : SKANRAY EUROPE SRL (Italy)
India
2 others
IIb
93/42
office@skanray.com
EUDAMED record
Report an error
Sophysa FDA
France
2 others
IIb, III
93/42
Website
contact@sophysa.fr
EUDAMED record
Report an error
Starmed FDA
EU representative : Emergo Europe B.V. (Netherlands)
Germany, South Korea
2 others
I, IIb
MDR, 93/42
Website
info@starmed.eu
EUDAMED record
Report an error
Sunnyou
EU representative : Lotus NL B.V. (Netherlands)
China
2 others
I, IIa
MDR
EUDAMED record
Report an error
TavTech FDA
EU representative : mdi Europa GmbH (Germany)
Israel
2 others
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Tecnomed Italia
Italy
2 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Teleflex FDA
EU representative : Teleflex Medical (Ireland)
Ireland, United States
2 others
I, IIb
MDR, 93/42
Website
orders.intl@teleflex.com
EUDAMED record
Report an error
Tensplus FDA
EU representative : Caretechion GmbH (Germany)
Hong Kong SAR China
2 others
I, IIa
MDR
EUDAMED record
Report an error
Topsonmed
EU representative : Prolinx GmbH (Germany)
China
TOPSONMED, LC-APAP Pro LC-CPAP, LC-APAP, LC-APAP Pro,SS100, SS110, SS210, SS210 Pro; SS200, SS200 Pro 3 refs TOPSONMED, LC-BPAP-20 93/42 TOPSONMED, LC-BPAP-20A 93/42 TOPSONMED, LC-BPAP-20T 93/42 TOPSONMED, LC-BPAP-25 LC-BPAP-25T, LC-BPAP-25A, LC-BPAP-25, LC-BPAP-30T, SS130, SS150, SS160, SS170, SS230, SS230 Pro, SS255, SS255 Pro, SS280, SS280 Pro 3 refs 2 others
IIa
MDR, 93/42
sales@topsonmed.com
EUDAMED record
Report an error
Tuyunmed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
2 others
IIa
MDR
radepartment@tuyunmed.com
EUDAMED record
Report an error
Verathon FDA
EU representative : Verathon Medical (Europe) B. V. (Netherlands)
Canada, United States
2 others
I, IIa
MDR
Website
Regulatory.Compliance@verathon.com
EUDAMED record
Report an error
VERTIGO di CARLO TACCHINO
Italy
2 others
I
MDR
EUDAMED record
Report an error
Wonjin Mulsan FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
2 others
IIa
MDR
Website
EUDAMED record
Report an error
Z-Systems FDA
EU representative : Axxos GmbH (Germany)
Switzerland
2 others
IIa
93/42
quality@zsystems.com
EUDAMED record
Report an error
Zepf Medical Instruments
Germany
2 others
I
MDR
Website
info@zepf-medical-instruments.de
EUDAMED record
Report an error
Zhenjiang Excellence Medical Tech
EU representative : SUNGO Europe B.V. (Netherlands)
China
2 others
I
MDR
EUDAMED record
Report an error
Παππας Ν. & Σια Οε
Greece
2 others
I
MDR
Website
info@medical-experts.gr
EUDAMED record
Report an error
FIM Medical FDA
France
3 others
I, IIa
MDR, 93/42
Website
contact@fim-medical.com
EUDAMED record
Report an error
Finndent
Finland
3 others
I, IIa
93/42
Website
EUDAMED record
Report an error
Icare Finland FDA
Finland
3 others
I, IIa
MDR, 93/42
Website
customercare@icare-world.com
EUDAMED record
Report an error
Sublimed FDA
France
3 others
I, IIa
MDR, 93/42
Website
PRRC-Sublimed@subli-med.com
EUDAMED record
Report an error
Dent4You FDA
EU representative : Coltène/Whaledent GmbH + Co. KG (Germany)
Switzerland
2 others
IIa
MDR
info.ch@coltene.com
EUDAMED record
Report an error
Jeisys FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
2 others
IIb
93/42
Website
EUDAMED record
Report an error
Storz Medical FDA
EU representative : STORZ MEDICAL Deutschland GmbH (Germany)
Switzerland
2 others
IIa, IIb
MDR, 93/42
Website
info@storzmedical.com
EUDAMED record
Report an error
66Vision
EU representative : Wellkang Ltd (Northern Ireland)
China
1 other
I
MDR
EUDAMED record
Report an error
ACEM
Italy
1 other
I
MDR
Website
info@acem.it
EUDAMED record
Report an error
Adamosrl
Italy
1 other
I
MDR
Website
info@adamosrl.com
EUDAMED record
Report an error
Adss FDA
EU representative : Prolinx GmbH (Germany)
China
Diode Laser Therapy System FG2000-B,FG2000-B Pro,FG2000D+ 001,FG2000D+ 003,FG2000D+005,FG2000D+ 006,QRYO-101104,AlphaSheer Max Diode Laser Therapy System FG2000-D+; FG2000-D+Pro; FG2000-E 3 refs Fractional CO2 Laser Therapy System FG900，FG900-S，FG900-S2 2 refs Intensity Pulsed Light Therapy System VE2000, VE2000 Pro, VE2000 Pro001, VE2000 Pro002, VE2000 Pro003 Long pulse multiple-wavelength laser system CMC-01、CMC-02、CMC-03 1 other
IIa, IIb
MDR
EUDAMED record
Report an error
Alton FDA
EU representative : Medunion S.L. (Spain) and 1 other
China
1 other
I, IIa
MDR
info@alton.com.cn
EUDAMED record
Report an error
Artzt
Germany
1 other
I
MDR
Website
info@artzt.eu
EUDAMED record
Report an error
Asskea FDA
Germany
1 other
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
B.Well Swiss
EU representative : Blue Broccoli GmbH (Liechtenstein)
Switzerland
MED-111 Compressor nebulizer MED-120, PRO-110, PRO-115, TH-130, MED-111, MED-130, PRO-100, PRO-101 3 refs MED-50 Automatic blood pressure monitor MED-53, MED-55, MED-50, MED-51, MED-56, MED-58, MED-80, MED-81, MED-88, MED-55 G.IV, TH-75 3 refs MED-57 Wrist blood pressure monitor MED-57, MED-59, MED-89 PRO-22 Automatic blood pressure monitor PRO-33, PRO-35, PRO-36, PRO-22, PRO-25, PRO-26, TH-71, TH-73, MED-53 G.IV 3 refs PRO-30 Semi-automatic blood pressure monitor 2 refs 1 other
IIa
MDR
info@bwell-swiss.ch
EUDAMED record
Report an error
Beijing Honkon Technologies FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
1 other
IIb
MDR, 93/42
EUDAMED record
Report an error
Beijing KES Biology Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
1 other
IIb
MDR, 93/42
EUDAMED record
Report an error
Beijing Siriusmed Medical Device
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
1 other
IIb
93/42
service@siriusmedica.com
EUDAMED record
Report an error
BHM-Tech Produktionsgesellschaft m.b.H FDA
Austria
1 other
IIa
93/42
Website
info@bhm-tech.com
EUDAMED record
Report an error
Biomedical FDA
Italy
1 other
IIa, IIb
93/42
Website
info@biomedical-bio.net
EUDAMED record
Report an error
Bmedicalsystems FDA
Luxembourg
1 other
IIa
MDR
Website
EUDAMED record
Report an error
Brownmed FDA
EU representative : AR Experts B.V. (Netherlands)
United States
1 other
I
MDR
EUDAMED record
Report an error
Brütsch Technology
EU representative : MedEnvoy Global BV (Netherlands)
Switzerland
1 other
I
MDR
Website
EUDAMED record
Report an error
Cardios
EU representative : Obelis s.a. (Belgium)
Brazil
1 other
IIa
93/42
Website
sales@cardios.com.br
EUDAMED record
Report an error
Centralsurgical FDA
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
1 other
I
MDR
Website
EUDAMED record
Report an error
ChangZhou BoMedent Medical Technology FDA
EU representative : Caretechion GmbH (Germany)
China
1 other
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Chiromega
Slovakia
1 other
IIa
93/42
Website
EUDAMED record
Report an error
ClaroNav FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
1 other
I, IIa, IIb
MDR, 93/42
Website
info@claronav.com
EUDAMED record
Report an error
Cogentix Medical FDA
EU representative : Medical Measurement Systems B.V. (Netherlands)
United States
1 other
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Compumedics Germany FDA
Germany
1 other
IIa
MDR, 93/42
Website
info@dwl.de
EUDAMED record
Report an error
Cook Vandergrift FDA
EU representative : COOK MEDICAL EUROPE LIMITED (Ireland)
United States
1 other
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Cymo
Netherlands
1 other
I
MDR
Website
EUDAMED record
Report an error
David Medical Europe, Unipessoal Lda
Portugal
1 other
IIa, IIb
MDR
info@davideuropa.pt
EUDAMED record
Report an error
Dr. Langer Medical
Germany
1 other
I, IIa
MDR
Website
info@medical-langer.de
EUDAMED record
Report an error
E.M.S. Electro Medical Systems FDA
EU representative : EMS FRANCE SARL (France)
Switzerland
1 other
I, IIa
MDR
Website
EUDAMED record
Report an error
Emed
Poland
1 other
I, IIb
MDR
Website
EUDAMED record
Report an error
Ertunç Özcan
Türkiye
1 other
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Eurosets FDA
Italy
1 other
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Fleming Medical
EU representative : Fleming Medical (Ireland)
China, Ireland
1 other
I, IIa
MDR, 93/42
Website
quality@flemingmedical.ie
EUDAMED record
Report an error
Fritz Stephan
Germany
1 other
IIb
MDR
Website
info@stephan-gmbh.com
EUDAMED record
Report an error
Gaush FDA
EU representative : Eunitor GmbH (Germany) and 1 other
China
1 other
I, IIa
MDR
Info@gaush.com
EUDAMED record
Report an error
Geratherm
Germany
1 other
IIa
93/42
Website
info@geratherm.com
EUDAMED record
Report an error
Geratherm Respiratory
Germany
1 other
IIa
MDR, 93/42
Website
info@geratherm-respiratory.com
EUDAMED record
Report an error
Guangzhou Xinbo Electronic FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
1 other
IIa
93/42
EUDAMED record
Report an error
Gubbemed
Germany
1 other
I
MDR
Website
info@gubbemed.de
EUDAMED record
Report an error
Habys
Poland
1 other
I
MDR
info@habys.pl
EUDAMED record
Report an error
Halcamp
Poland
1 other
I
MDR
EUDAMED record
Report an error
Hefei Mt Medical FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
CR,CR-1,CR-2,CR-3,CR-4,CR-5,CR-6,CR-7,CR-8,CR-9,CR-10,CR-11,CR-12,CR-11,CR-12,CR-13,CR-14,CR-15,CR-16,CR-17,CR-18,CR-19,CR-20，CR-21,CR-22,CR-23,CR-24,CR-25，CR-26,CR-27,CR-28,CR-29,CR-30,CR-31,CR-32,CR-33,CR-34 DST-1A,DST-1B,DST-1C,DST-1,DST-500,DST-500A,DST-500B,DST-500C,DST-500D,DST-700,DST-700A,DST-700B,DST-700G,DST-700I,DST-700Q, etc 3 refs MT-EL01A，MT-EL01B，MT-EL01C，MT-EL02A，MT-EL02B，MT-EL02C，MT-EL03A，MT-EL03B,MT-EL03C,MT-EL04，MT-EL05A，MT-EL05B，MT-EL05C，MT-EL06A,MT-EL06B,MT-EL06C，MT-EL07A，MT-EL07B，etc. 3 refs MT-OEB01,MT-OEB02,MT-OEB03,MT-OEB04,MT-OEB05,MT-OEB06,MT-OEB07,MT-OEB08,MT-OEB09,MT-OEB10,MT-OEB11,MT-OEB12,MT-OEB13,MT-OEB14,MT-OEB15,MT-OEB16,MT-OEB17, etc. 3 refs Operation Lamp MT-SL500D 3 refs 1 other YDE700/500,YDE700/700,YDE500/500,YDE700,YDE500,YDE500D,YDE700/500 A,YDE700/700 A,YDE500/500 A,YDE700 A,YDE500 A,YDE500D A， etc 3 refs
I
MDR
info@xn--mtmedical-w79d.com
EUDAMED record
Report an error
Honsun (Nantong)
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
China
1 other
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Innomed FDA
Hungary
1 other
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Jaeger Medical FDA
Germany
1 other
IIa
93/42
Website
EUDAMED record
Report an error
Jiangsu Hanyao Medical Devices FDA
EU representative : HUMISS TRADING S. L. (Spain)
China
1 other
IIa
MDR
EUDAMED record
Report an error
Kanmed
Sweden
1 other
I, IIb
MDR
Website
qara@kanmed.se
EUDAMED record
Report an error
Koolcare FDA
EU representative : Prolinx GmbH (Germany)
China
BIPA BI LFE Wärmegürtel KK-IW-N 45 3 refs Dr. Max Cooling Patches 2 refs Dr. Max Hot&Cold Therapy 3 refs Dr. Max Instant Cold Pack 2 refs KK-IW-N(40B,45B,70B,50B,49B,48B,55B,44B,42B,37B,30B,36B,25B,39B,34B,62B,60B,65B,72B,82B,75B,80B,120B),KK-IW-N(40D,45D,70D,50D,49D,48D,55D,44D,42D,37D,30D,36D,25D,39D,34D,62D,60D,65D,72D,82D,75D,80D,120D,215D, 185D,175D) 1 other Nexcare™ Heat Patch KK-IW-N(40A,45A,70A,50A,49A,48A,55A,44A,42A,30A,36A,25A,39A,34A,62A,60A,65A,72A,82A,75A,80A,120A),KK-IW-N(40C,45C,70C,50C,49C,48C,55C,44C,42C,30C,36C,25C,35C,39C,34C,62C,60C,65C,72C,82C,75C,80C,120C,215C,185C,175C) 3 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
Laserconn FDA
EU representative : Prolinx GmbH (Germany)
China
1 other
IIb
93/42
EUDAMED record
Report an error
Laseroptek FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
1 other
IIb
93/42
EUDAMED record
Report an error
Long Island Technology Group FDA
EU representative : Obelis s.a. (Belgium)
United States
1 other
I
MDR
Website
EUDAMED record
Report an error
MacroLux Medical Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
1 other
I, IIa
MDR
EUDAMED record
Report an error
Matachana
Spain
1 other
IIa
MDR
Website
info@matachana.com
EUDAMED record
Report an error
Medical Devices
EU representative : Obelis s.a. (Belgium)
Pakistan
1 other
I
MDR
Website
EUDAMED record
Report an error
Medical Products Research
Italy
1 other
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
medifa FDA
Germany
1 other
I
MDR
Website
info.operatingtables@medifa.com
EUDAMED record
Report an error
MediTouch
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Israel
1 other
I
MDR
Website
info@meditouch.co.il
EUDAMED record
Report an error
MedRx FDA
EU representative : DGS Diagnostics A/S (Denmark)
United States
1 other
I, IIa
MDR
Website
quality@medrx-diagnostics.com
EUDAMED record
Report an error
MESI, razvoj medicinskih naprav, d.o.o
Slovenia
1 other
IIa
MDR, 93/42
Website
info@mesimedical.com
EUDAMED record
Report an error
Micro-Nx FDA
EU representative : Javitech Consulting GmbH (Germany)
South Korea
1 other
IIa
93/42
Website
EUDAMED record
Report an error
Mitaka Kohki FDA
EU representative : Mitaka Europe GmbH (Germany)
Japan
1 other
I
MDR
Website
EUDAMED record
Report an error
Neko Health FDA
Sweden
1 other
I
MDR
Website
hello@nekohealth.com
EUDAMED record
Report an error
Norav FDA
EU representative : Norav Medical GmbH (Germany)
Germany, Israel
1 other
IIa
MDR
Website
info@norav.com
EUDAMED record
Report an error
Novos
Türkiye
1 other
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Opt Surgisystems
Italy
1 other
I, IIb
MDR
Website
EUDAMED record
Report an error
Optopol FDA
Poland
1 other
I, IIa
MDR, 93/42
Website
info@optopol.com.pl
EUDAMED record
Report an error
Ordisi
Spain
1 other
I, IIa
MDR
Website
EUDAMED record
Report an error
Pathme FDA
Germany
1 other
I, IIa
MDR
Website
info@pathme.de
EUDAMED record
Report an error
PENTAX-Aohua Medical Technologies
EU representative : PENTAX Europe GmbH (Germany)
China
1 other
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Project Blue Generation
Italy
1 other
IIa, IIb
93/42
EUDAMED record
Report an error
Pumasrl
Italy
1 other
I
MDR
Website
EUDAMED record
Report an error
Qingdao Yasee Medical Device FDA
EU representative : MedPath GmbH (Germany)
China
1 other
IIa
93/42
EUDAMED record
Report an error
S.M.D
Italy
1 other
I
MDR
Website
EUDAMED record
Report an error
Saikangmedical FDA
EU representative : Everbiz GmbH (Germany) and 1 other
China
A045-1,A046,A048,A105,A205,A3001,A3001-3,A3001A,A3008A-1,A3008B-1,SKF-A,AKF-B,SKF-C 3 refs A98-1S,A98-2,A98-3,A98-4,A98-9,A98NE,A99-1,A99-5,A99-6,A99-7,A99-8,A99-12,A99-13,A99-14,A99F,A100-4,A100-4A,A100-4B,A106-2,A106-3,A106-3A,A106-3S,A109-2,A110,A200,A200-1,A201,A202,A301,A302,A401,A501,A2000,A3000B,SKL-A,SKL-B,SKL-C,SKL-D,etc 3 refs AInno X22 2 refs SDL-C0238 2 refs SK-L201,SK-L202,SK-L204,SK-L205,SK-L206,SK-L207,SK-L208,SK-L210,SK-L212,SK-L213,SK-L260,SK-L261,SK-L262,SK-L274,SK-L275,SK-L276,SK-L226,SK-L278,SK-L227,SK-L275-M,SK-L203,SK-L323,SK-L316,SK-L317,SK-L318,SK-L319,SK-L320,SK-L321,SK-L322,SK-L325,etc 3 refs 1 other
I
MDR
Website
EUDAMED record
Report an error
Sechrist Industries FDA
EU representative : Obelis s.a. (Belgium)
United States
1 other
IIb
93/42
Website
EUDAMED record
Report an error
Shenb FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
1 other
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Shenzhen Jumper Medical Equipment FDA
EU representative : MedPath GmbH (Germany)
China
1 other
IIa
MDR
EUDAMED record
Report an error
ShenZhen ZhengKang Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
1 other
IIa
MDR, 93/42
EUDAMED record
Report an error
Siare
Italy
1 other
IIb
MDR
Website
EUDAMED record
Report an error
Sometech
EU representative : AR Experts B.V. (Netherlands)
South Korea
1 other
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Soterix Medical FDA
EU representative : mdi Europa GmbH (Germany)
United States
1 other
I, IIa
MDR, 93/42
contact@soterixmedical.com
EUDAMED record
Report an error
Sterlab
France
1 other
I, IIa
MDR, 93/42
Website
contact@sterlab.com
EUDAMED record
Report an error
Takara Belmont FDA
EU representative : Takara Company Europe GmbH (Germany)
Japan
1 other
I, IIa
MDR
EUDAMED record
Report an error
Taktvoll FDA
EU representative : MedPath GmbH (Germany)
China
1 other
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
TECH-MED Roman Pasławski Spółka Jawna
Poland
1 other
I
MDR
Website
EUDAMED record
Report an error
Teeter
EU representative : MDSS GmbH (Germany)
United States
1 other
I
MDR
Website
EUDAMED record
Report an error
TEKNA Manufacturing FDA
EU representative : Obelis s.a. (Belgium)
India
1 other
IIb
93/42
Website
EUDAMED record
Report an error
Theraclion
France
1 other
I, IIb
MDR, 93/42
Website
contact@theraclion.com
EUDAMED record
Report an error
Tma Medical Equipment
EU representative : TSI Quality Services (Denmark)
United Kingdom (ex Northern Ireland)
1 other
I
MDR
EUDAMED record
Report an error
Triup
EU representative : MedPath GmbH (Germany)
China
1 other
I
MDR
EUDAMED record
Report an error
Univet Loupes FDA
Italy
1 other
I
MDR
EUDAMED record
Report an error
Vantive FDA
EU representative : Vantive S.r.l. (Italy)
Switzerland
1 other
IIb
MDR
Website
EUDAMED record
Report an error
Vehu
Germany
1 other
I
MDR
Website
info@vehu.com
EUDAMED record
Report an error
Vernacare FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
1 other
IIa
93/42
Website
info@vernacare.com
EUDAMED record
Report an error
VG Medical Technology
EU representative : Lotus NL B.V. (Netherlands)
China
1 other
I
MDR
Website
EUDAMED record
Report an error
Weyo Surgical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
4K Medical Endoscopic Camera System wMerak 40u, wlerak 40p, wMerak 40a, wMlerak40g, wMerak40s, wMerak 40e, wMerak40c, wMerak40b, wDubhe V40A, wDubhe V40B、wDubhe V40C、wDubhe V40D, wDubhe V40E、wDubhe V40F 3 refs Medical Endoscopic Camera System wDubhe V20A, wDubhe V20B, wDubhe V20C, wDubhe V20D, wDubhe V20E, wDubhe V20F 3 refs Medical Endoscopic LED Cold Light Source wMizar 10u、wMizar 10p、wMizar 10a、wMizar 10c、wMizar V10A、wMizar V10B、wMizar V10C、 wMizar V10D、wMizar V10E、wMizar V10F 3 refs wDubhe E20u、 wDubhe E20p、 wDubhe E20a、 wDubhe E20c、 wDubhe E20g、 wDubhe E20s、 wDubhe E20e、 wDubhe E20b 3 refs wMerak F40u wMerak F40p wMerak F40a wMerak F40g wMerak F40s wMerak F40e wMerak F40c wMerak F40b 3 refs 1 other
I
MDR
EUDAMED record
Report an error
Wismed
EU representative : TNMC Devices Llc (Croatia)
South Africa
1 other
I
MDR
Website
EUDAMED record
Report an error
Yeasn FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
1 other
I
MDR
sale@yeasn.com
EUDAMED record
Report an error
Yelatma Instrument-Making Enterprise Joint-Stock
EU representative : QbD RepS BV (Belgium)
Russia
1 other
IIa
93/42
Website
EUDAMED record
Report an error
Zhejiang Geyi Medical Instrument FDA
EU representative : MedPath GmbH (Germany)
China
1 other
I, IIa
MDR
EUDAMED record
Report an error
Zoll FDA
EU representative : ZOLL International Holding B.V. (Netherlands)
China, United States
1 other
IIb
MDR, 93/42
Website
info@zoll.com
EUDAMED record
Report an error
CU Medical Systems
EU representative : MDSS GmbH (Germany)
South Korea
4 others
IIb
93/42
service@cu911.com
EUDAMED record
Report an error
Alnitec
Italy
1 other OZO2 93/42 (no longer marketed)
IIa, IIb
93/42
Website
info@alnitec.it
EUDAMED record
Report an error
Cometa FDA
Italy
1 other
I, IIa
MDR, 93/42
Website
sales@cometasystems.com
EUDAMED record
Report an error
Shanghai Bojin Medical Instrument FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
China
1 other
IIa
MDR, 93/42
EUDAMED record
Report an error
Acare Technology FDA
EU representative : Surpass Biomedical Europe B.V. (Netherlands)
Taiwan
I, IIa, IIb
MDR, 93/42
info@acarecorp.com
EUDAMED record
Report an error
Acoresmed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
93/42
Website
qa@acoresmed.com
EUDAMED record
Report an error
Acus Med
Poland
I
MDR
Website
info@acusmed.pl
EUDAMED record
Report an error
Aerotel FDA
EU representative : AF Pharma Service Europe SL (Spain)
Israel
IIa
93/42
EUDAMED record
Report an error
Akas Medical Equipment
EU representative : Amstermed B.V. (Netherlands)
India
IIb
93/42
Website
EUDAMED record
Report an error
Apoza FDA
EU representative : Luana Med. B.V. (Netherlands)
Taiwan
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Avitamedical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa, IIb, III
MDR, 93/42
Website
regulatory@avitamedical.com
EUDAMED record
Report an error
Balt Usa FDA
EU representative : BALT EXTRUSION SAS (France)
United States
I, IIa, IIb, III
93/42
Website
PRRC@baltgroup.com
EUDAMED record
Report an error
Bandelin
Germany
I
MDR
Website
info@bandelin.com
EUDAMED record
Report an error
Bedfont FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
EUDAMED record
Report an error
Beijing KellyMed
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Belmont Medical Technologies FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIb
MDR, 93/42
Website
regulatory@belmontmedtech.com
EUDAMED record
Report an error
Bertec FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
info@bertec.com
EUDAMED record
Report an error
Beyond Air FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
Bioswing
Germany
I
MDR
Website
info@bioswing.de
EUDAMED record
Report an error
BMC Medical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
EUDAMED record
Report an error
Bngmed
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
IIa, IIb
MDR, 93/42
Website
info@bngmed.com
EUDAMED record
Report an error
Bodystat FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
Isle of Man
IIa
93/42
Website
info@bodystat.com
EUDAMED record
Report an error
Boscarol
Italy
IIa
MDR
Website
raq@boscarol.it
EUDAMED record
Report an error
Brandon Medical
EU representative : RegTrac Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Brosmed FDA
EU representative : Brosmed Medical B.V. (Netherlands)
China
I
93/42
Website
EUDAMED record
Report an error
Changsha Fourier Medical Technology
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
China
I, IIa
MDR
Website
info@fftai.com
EUDAMED record
Report an error
Cinogy
Germany
IIa, IIb
MDR
Website
eudamed@cinogy.de
EUDAMED record
Report an error
Classys FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
IIa, IIb
93/42
EUDAMED record
Report an error
Clearwax
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
info@clearwax.co.uk
EUDAMED record
Report an error
Cofoe FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
Website
EUDAMED record
Report an error
Costruzione Strumenti Oftalmici C.S.O
Italy
I, IIa
MDR, 93/42
Website
cso@csoitalia.it
EUDAMED record
Report an error
Daichuan Medical (Shenzhen)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Delfimedical FDA
EU representative : International Associates Auditing & Certification Limited (Ireland)
Canada
I
MDR
Website
info@delfimedical.com
EUDAMED record
Report an error
Digitimer FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
sales@digitimer.com
EUDAMED record
Report an error
Dongguan Kaiser Technology FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Dongguan Q & S Electronic Manufacturing
EU representative : MedNet EC-REP GmbH (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
Dongguan Shengtu Industrial
EU representative : Bauer + Herzog B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
DTL Dental Equipment Manufacture
EU representative : Kingsmead Service B.V. (Netherlands)
China
Dental Air Motor DP74,DE74 2 refs Dental Contra Angle Handpiece DP11L,DP11,DE11,DP61L,DP41L,DP15L,SG20KL,SG20K,DP01L,DP01,DE01 3 refs Dental Electric Motor iM2X Dental High Speed handpiece HP0,HP0B2,HP3,HP3KL,HP4,HP4KL,HP1,HP1K,HP1KL,HP1NL,HP2,HP2K,HP2KL,HP2NL,HP45,HP45K,HP45KL 3 refs Dental High Speed handpiece HP1LG、HP2LG、HP45LG 3 refs
IIa
MDR
Website
info@dtl-dent.com
EUDAMED record
Report an error
ECO Medical Technology (Nanjing)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR, 93/42
info@njeco.com.cn
EUDAMED record
Report an error
Edwards FDA
EU representative : Edwards Lifesciences GmbH (Germany)
United States
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Eemagine FDA
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Ellex FDA
EU representative : E C REP LIMITED (Ireland)
Australia
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Elmed Elektronik Ve Medikal San Tic
Türkiye
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Emblation FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIb
93/42
Website
info@emblation.com
EUDAMED record
Report an error
EMS Physio FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Endomed
Germany
IIa, IIb
MDR
Website
info@endomed.com
EUDAMED record
Report an error
Engineering Production Equipment Medical
Italy
IIb
93/42
Website
EUDAMED record
Report an error
Etablissements Albert Legrand
France
I
MDR
Website
info@a-legrand.com
EUDAMED record
Report an error
F Care Systems FDA
Belgium
IIa, IIb
93/42
Website
info@fcaresystems.com
EUDAMED record
Report an error
Flaem Nuova FDA
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Fukuda FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
I, IIa, IIb
MDR
info@fukuda.co.jp
EUDAMED record
Report an error
G.N.S neoLaser FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Israel
IIb
MDR
Website
info@neo-laser.com
EUDAMED record
Report an error
Ganshorn FDA
Germany
I, IIa
MDR, 93/42
Website
info@ganshorn.de
EUDAMED record
Report an error
Globalipl FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
GM Instruments FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I, IIa
MDR
Website
EUDAMED record
Report an error
Good Doctors FDA
EU representative : Good Doctors Germany GmbH (Germany)
South Korea
I, IIa
MDR
EUDAMED record
Report an error
Guangzhou Potent Medical Equipment Joint-Stock FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
HZ-A, HZ-B, HZ-E, HZ-40 Ndly 12B Potent HP90, Potent HP100, Potent HP120, Potent HP140, Potent HP150 PT-UFM-A, PT-UFM-B, PT-UFM-C TFL-A, TFL-B
IIa, IIb
MDR
EUDAMED record
Report an error
Helmer Scientific
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Hi-Life Technology (Hebei)
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Hunan Accurate Bio-Medical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
regulation@accbiomed.com
EUDAMED record
Report an error
IDCP
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Ilo FDA
Germany
I
MDR
Website
info@ilo.com
EUDAMED record
Report an error
Infimed
Poland
I
MDR
Website
office@infimed.pl
EUDAMED record
Report an error
Infinovo
EU representative : Llins Service & Consulting GmbH (Germany)
China
IIa
93/42
Info@infinovo.com
EUDAMED record
Report an error
International Group Medical Technology Electronics
Germany
I, IIa
MDR
Website
info@ig-medical.de
EUDAMED record
Report an error
INVIDIA Medical
Germany
I
MDR
info@invidia-medical.de
EUDAMED record
Report an error
JW Pharmaceutical
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIa, IIb
93/42
export@jw-holdings.co.kr
EUDAMED record
Report an error
KASO Medical Technology
EU representative : Share info GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Keewell
EU representative : Wellita International BV (Belgium)
China
IIb
MDR, 93/42
Website
info@keewell.cn
EUDAMED record
Report an error
Kettex
Czechia
I
MDR
Website
info@kettex.eu
EUDAMED record
Report an error
Kinetec FDA
France
IIa
MDR
contact@kinetec.fr
EUDAMED record
Report an error
Kingonmed FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Kirchner & Wilhelm FDA
Germany
I
MDR
Website
info@kawemed.de
EUDAMED record
Report an error
Laboratoires I2M
France
IIa
93/42
Website
EUDAMED record
Report an error
Lifelines FDA
EU representative : Incereb Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Loewensteinmedical FDA
Germany
IIb
MDR, 93/42
Website
info@loewensteinmedical.com
EUDAMED record
Report an error
Longfian Scitech FDA
EU representative : Obelis s.a. (Belgium)
China
IIb
MDR
EUDAMED record
Report an error
LSO Medical
France
IIb
93/42
Website
regulatory@lsomedical.com
EUDAMED record
Report an error
Luciole Medical
EU representative : Veranex Germany GmbH (Germany)
Switzerland
I, IIa, III
MDR
Website
info@luciolemedical.ch
EUDAMED record
Report an error
Med Elettronica
Italy
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Med-Logics FDA
EU representative : E C REP LIMITED (Ireland)
United States
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Medical Data Technology
Belgium
IIa
MDR
Website
contact@medatec.be
EUDAMED record
Report an error
Medicap
Germany
IIa
93/42
Website
EUDAMED record
Report an error
Medrena
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIb
MDR, 93/42
sales@medrena.com
EUDAMED record
Report an error
Mekics FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Melag
Germany
IIa, IIb
MDR
Website
info@melag.de
EUDAMED record
Report an error
Motek Medical FDA
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Möller Medical FDA
Germany
I, IIa, IIb
MDR
Website
info@moeller-medical.com
EUDAMED record
Report an error
Nanjing Superstar Medical Equipment
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
EUDAMED record
Report an error
Orgaterm
Germany
I
93/42
Website
info@orgaterm.de
EUDAMED record
Report an error
Ortoma FDA
Sweden
I, IIb
MDR
Website
info@ortoma.com
EUDAMED record
Report an error
Peaksonic FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Poweam
EU representative : SUNGO Europe B.V. (Netherlands)
China
Dental Chair PM-2311, PM-231118, PM-2318L5, PM-3280, PM-3260, PM-3290, PM-3250, PM-3270, X008, X009, X142, X144, X146, X147, X148, X149 3 refs Operating Lamp LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED 3 refs Operating Table MB1000,MB3000D,MB3000A,MB3000,MB4000,MB4000A,MB4000B,MB5000,MB6000,HB1000,HB2000,HB3000C,HB5000,HB4000A,HB4000A1,HB4000,HB3000,HB7000,HB7000S,HB7000A,HB8000 3 refs Operation Microscope OPT-1000,OPT-2000,OPT-3000,OPT-4000, OPT-1000ent, OPT-1000,OPT-1200, OPT-1300E , OPT-1800E, OPT500E, OPT400E,JDY-I,JDY-II, JDY-Z,JDY-FHD, YDJ-FHD-1,DZY-16,DZY-16A,DZY-16B,JDY-12B, JDY-12BI, JDY-12B LED, JDY-12BI LED, JDY-12B II LED 3 refs Slit Lamp microscope K2, K2A, K5L, J3, J5L ,J9D, J8, J8D,P2 3 refs
I
MDR
EUDAMED record
Report an error
PROCEPT BioRobotics FDA
EU representative : Qualrep Services B.V. (Netherlands)
United States
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Project Engineering
Italy
IIb
MDR, 93/42
Website
info@proeng.it
EUDAMED record
Report an error
Prosimed
Italy
I
MDR
Website
info@prosimed.it
EUDAMED record
Report an error
Raumedic FDA
Germany
IIa
MDR, 93/42
Website
contact@raumedic.com
EUDAMED record
Report an error
Rejoin
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR, 93/42
Website
EUDAMED record
Report an error
SCHNELL Trainingsgeräte
Germany
I
MDR
Website
info@schnell-training.com
EUDAMED record
Report an error
Schupp
Germany
I
MDR
Website
EUDAMED record
Report an error
Shanghai Chuangshi Medical Technology (Group) FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shanwei Perfect Medical Instruments FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I, IIa
MDR
EUDAMED record
Report an error
Shenzhen CERTAINN Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR, 93/42
Website
service@moptim.cn
EUDAMED record
Report an error
Shenzhen IMDK Medical Technology FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
Arm Blood Pressure Monitor BPM-A7VL Dopplo YM-2T8 93/42 Dopplo YM-2T9 93/42 IMDK Pulse Oximeter C101H1, C101A2, PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT 3 refs Wrist Blood Pressure monitor BPM-W1VL
IIa
MDR, 93/42
service@imdker.com
EUDAMED record
Report an error
Sibbo Medical Devices
Finland
I
MDR
Website
info@sibbomedicaldevices.com
EUDAMED record
Report an error
Soniquence FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Surgical Appliances
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Surgnova FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
qara@surgnova.com
EUDAMED record
Report an error
Symbios
EU representative : Symbios France SAS (France)
Switzerland
IIa
MDR, 93/42
info@symbios.ch
EUDAMED record
Report an error
Taidoc FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
IIa
MDR, 93/42
Website
sales@taidoc.com
EUDAMED record
Report an error
Tanita FDA
EU representative : TANITA Europe B.V. (Netherlands)
Japan
IIa
93/42
info@tanita.eu
EUDAMED record
Report an error
Thermasolutions FDA
Netherlands
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Titanox
Italy
I, IIb
MDR
Website
info@titanox.it
EUDAMED record
Report an error
Ultradent FDA
EU representative : Ultradent Products GmbH (Germany)
Germany, United States
I
MDR
Website
info@ultradent.de
EUDAMED record
Report an error
Uscom FDA
EU representative : Emergo Europe B.V. (Netherlands)
Australia, Hungary
IIa
93/42
Website
info@uscom.com.au
EUDAMED record
Report an error
Uzinmedicare FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
V.I.M.S Video Interventionnelle Medicale Scientifique
France
I, IIa
MDR
contact.vims@zimmerbiomet.com
EUDAMED record
Report an error
Visia imaging FDA
Italy
I, IIa
MDR, 93/42
quality.hcs.it@topcon.com
EUDAMED record
Report an error
waveguide medical systems
Austria
IIb
93/42
Website
info@waveguide-medical.com
EUDAMED record
Report an error
Weihai Wego Qiquan Medical Equipment
EU representative : Everbiz GmbH (Germany)
China
Electrical Operating Table WG-OT300, WG-OT320A, WG-OT340, WG-OT340A, WG-OT360, WG-OT360A, WG-OT380, WG-OT380A, WG-OT390, ET100, ET110, ET120, ET200, ET210, ET220 3 refs Manual operating table WG-OT100A, WG-OT100B, WG-OT100C, WG-OT100D, WG-OT100E 3 refs Medical Bridge/Ceiling Pendant WG-DTQ, WG-DTQS, WG-DTA, WG-DTC, WG-DTEA , WG-DTEC, WG-DTM, WG-DTAO, WG-DTI, WG-DTPW, WG-DTHS 3 refs Operating Light WG-WYE ：3、5、7、77、75、55、53、755, WG-WYE+C：7C、5C、75C、55C, WG-WYE + M：3M、5M、7M、5CM、7CM、55CM、75CM, WG-WYEH：5、7、55、75、55C、75C、55CM、75CM, WG-WYEF：3、5、33、53、55、53CM 3 refs Operation Illuminating Lamp WG-ZM5, WG-ZM3, WG-ZM2, WG-ZM1 3 refs
I
MDR
EUDAMED record
Report an error
Wuzhou Aokace Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Zhangjiagang Braun Industry
EU representative : Humiss Beratung GmbH (Germany)
China
I
MDR
Website
Info@bihealth-care.com
EUDAMED record
Report an error
Zhengzhou PZ Laser Slim Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR, 93/42
EUDAMED record
Report an error
Śpiewak Tomasz P.P.H.U. " TOM-PAG"
Poland
I
MDR
info@tom-pag.pl
EUDAMED record
Report an error
Remote Diagnostic Technologies FDA
EU representative : Philips Medical Systems Nederland B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
2 others
I, IIb
MDR, 93/42
EUDAMED record
Report an error
3Ray
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
1 other
IIa
93/42
Website
info@3ray.net.cn
EUDAMED record
Report an error
Mcubetech FDA
EU representative : AR Experts B.V. (Netherlands)
South Korea
1 other
IIa
93/42
EUDAMED record
Report an error
Active Optical Systems FDA
EU representative : QS MEDICAL DEVICE REGISTRATION LTD (Cyprus)
Israel
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Aeonmed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Aerti
EU representative : Wellkang Ltd (Northern Ireland)
China
AE-3,AE-3-S,AE-3-W,AE-5,AE-5-S,AE-5-W,AE-8,AE-8-S,AE-8-W 3 refs AE-3-N,AE-3-NW,AE-5-N,AE-5-NW,AE-8-N,AE-8-NW 3 refs Medical Oxygen Concentrator AR-3,AR-5 2 refs Medical Oxygen Concentrator AR-3-N,AR-5-N 2 refs
IIb
MDR
Website
EUDAMED record
Report an error
Aiesi
Italy
I
MDR
COMMERCIALE@AIESI.IT
EUDAMED record
Report an error
AKTORmed FDA
Germany
I
MDR
Website
info@aktormed.com
EUDAMED record
Report an error
Alliage S/A Indústrias Médico Odontológica FDA
EU representative : ELS SOLUTIONS GDIA - UNIPESSOAL LDA. (Portugal)
Brazil
I
MDR
Website
EUDAMED record
Report an error
AOJ HEALTH Technology FDA
EU representative : Share info GmbH (Germany)
China
Ear wax Removal Tool Camera EWR-10, EWR-50 2 refs Electric Breast Pump BRP-301, BRP-302, BRP-303, BRP-304, BRP-305, BRP-306, BRP-307, BRP-308, BRP-201, BRP-202, BRP-203 3 refs Otoscope OT-501, OT-503 2 refs Ultrasonic Cleaner USC-10, USC-20 2 refs
I, IIa
MDR
regulation@aojmed.com
EUDAMED record
Report an error
AtriCure FDA
EU representative : AtriCure Europe B.V. (Netherlands)
United States
I, III
MDR
Website
EUDAMED record
Report an error
Avantsonic FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Avrasyamed
Türkiye
I, IIa
MDR, 93/42
Website
info@avrasyamed.com.tr
EUDAMED record
Report an error
Bienair FDA
EU representative : Bien-Air Europe Sàrl (France)
Switzerland
IIa
MDR, 93/42
Website
regulatory@bienair.com
EUDAMED record
Report an error
Bimini Health Tech FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
info@biminihealthtech.com
EUDAMED record
Report an error
Bionet FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIa, IIb
MDR
RA@ebionet.com
EUDAMED record
Report an error
Biosense Webster FDA
EU representative : Biosense Webster A Division of Johnson & Johnson Medical NV/SA (Belgium)
United States
IIa, IIb
MDR
EUDAMED_Enquiries@its.jnj.com
EUDAMED record
Report an error
BTS FDA
Italy
I
MDR
info@btsbioengineering.com
EUDAMED record
Report an error
Canon FDA
EU representative : Canon Medical Systems Europe B.V. (Netherlands)
Japan
I, IIa
MDR
eudamed-info@mail.canon
EUDAMED record
Report an error
Canyon Medical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
CB Healthcare Consulting
Germany
IIa
93/42
EUDAMED record
Report an error
Centervue FDA
Italy
IIa
MDR, 93/42
Website
info@icare-world.com
EUDAMED record
Report an error
Ceragem FDA
EU representative : Ceragem Europe GmbH (Germany)
South Korea
IIa
MDR, 93/42
EUDAMED record
Report an error
Chengdu Sani Medical Equipment FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
93/42
Website
EUDAMED record
Report an error
Chinesport
Italy
I
MDR
Website
regulatory@chinesport.it
EUDAMED record
Report an error
Chongqing Haifu Technology
EU representative : MDSS GmbH (Germany)
China
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Cicadadental FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
info@cicadadental.com
EUDAMED record
Report an error
Cisa Production
Italy
IIa
MDR
Website
info@cisagroup.it
EUDAMED record
Report an error
Clover Orthopedics
Italy
I
93/42
Website
info@cloverorthopedics.com
EUDAMED record
Report an error
Daesung Maref FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Daeyangmed FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa, IIb
MDR, 93/42
sales1@daeyangmed.com
EUDAMED record
Report an error
Dahlhausen
Germany
I
MDR
Website
info@dahlhausen.de
EUDAMED record
Report an error
DEBx Medical
Netherlands
IIb
93/42
Website
info@debx-medical.com
EUDAMED record
Report an error
Derungs
EU representative : Derungs Medical GmbH (Germany)
Switzerland
I
MDR
Website
mailbox@derungs.swiss
EUDAMED record
Report an error
Dimedlaser FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIb
MDR, 93/42
EUDAMED record
Report an error
Dr. Fenyves und Gut Deutschland
Germany
IIa
MDR
info@fg-deutschland.de
EUDAMED record
Report an error
DSE
EU representative : KTR Europe GmbH (Germany)
South Korea
IIb
93/42
EUDAMED record
Report an error
Easytech
Italy
I, IIa, IIb
MDR
info@easytechitalia.com
EUDAMED record
Report an error
Ehyadarman
EU representative : CERT3GLOBAL, UNIPESSOAL, LDA. (Portugal)
Iran
IIb
93/42
Website
qa@ehyadarman.com
EUDAMED record
Report an error
Elmac Elettronica FDA
Italy
IIb
93/42
info@elmaelettronica.com
EUDAMED record
Report an error
Empatica FDA
Italy
IIa
MDR
Website
info@empatica.com
EUDAMED record
Report an error
eResearchTechnology FDA
Germany
IIa
MDR
Website
customercare@clario.com
EUDAMED record
Report an error
Erka
Germany
I, IIa
MDR
Website
service@erka.org
EUDAMED record
Report an error
Escope Medical (Changzhou)
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Fitfaith FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Foshan Hongfeng FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I, IIa
MDR
Website
EUDAMED record
Report an error
Foshan MIC Medical Technology FDA
EU representative : Share info GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Gamasonic
France
I, IIb
MDR, 93/42
EUDAMED record
Report an error
General ASDE
Spain
I
MDR
Website
EUDAMED record
Report an error
Gentec FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany) and 1 other
China
IIa
MDR, 93/42
Website
info@gentec.com.cn
EUDAMED record
Report an error
GIMA
Italy
I
MDR
Website
EUDAMED record
Report an error
Guangzhou Hypnus Healthcare FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Guangzhou T.K Medical instrument FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Haemonetics FDA
EU representative : Haemonetics Italia s.r.l (Italy)
United States
IIa, IIb
MDR, 93/42
regulatoryeurope@haemonetics.com
EUDAMED record
Report an error
Haymed
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
Website
info@haymed.net
EUDAMED record
Report an error
Healthstats FDA
EU representative : MDSS GmbH (Germany)
Singapore
IIa
MDR
Website
EUDAMED record
Report an error
Heka Dental A S
Denmark
IIa
93/42
Website
info@heka-dental.dk
EUDAMED record
Report an error
Henan Kangdi Medical Devices
EU representative : HUMISS TRADING S. L. (Spain) and 1 other
China
Heat Pads 10x20cm 93/42 Heat Pads 10x20cm,10x13cm,7.4x11.2cm,7x9cm,9.6x12.8cm,5.5x9.2cm Heat Pads 7x9cm 93/42 Pain relief patch 12cmx18cm, 10cmx18cm, 11cmx15cm, 10cmx15cm, 10cmx13cm, 10cmx11cm, 8.4cmx12.5cm, 7cmx10cm, 6.5cmx4.2cm, 6.5cmx15cm
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Hico
Germany
I, IIb
MDR
Website
EUDAMED record
Report an error
Hill-Rom Services Pte FDA
EU representative : Welch Allyn Limited (Ireland)
Singapore
IIa
93/42
Website
EUDAMED record
Report an error
Inspital FDA
Germany
Accessory Trolley AB90.01 3 refs CELLING EXAMINATION LIGHT LD03.02W,LD03.01,LD05.06S,ALD.040,ALD.001,LD20.57,LD10.05,LD05.05,LD20.58,LD20.56,LD30.00, LD20.55,ALD.030,LD05.06,LD20.53S,LD20.52S,LD20.52,LD20.24S,LD20.24,LD10.03S,LD10.03, LD10.02S, LD10.02, LD10.01S, LP10.00,LP10.05,LD02.08,LD02.05,LD20.53,LD10.01 3 refs DOUBLE JOINT PENDANT FX40.05, FX40.10V, FX40.10S, FX40.15M, FX40.15D, FX40.20D, FX40.25M, SR10.22, SR10.32, SR10.33, FX41.03, FX41.07, FX40.15, FX40.10, FX40.20V, FX40.20, FX40.25, FX40.25M 3 refs Portable Suction Unit, 2L Plastic Jar SU60.08, SU60.06T, SU60.06, SU60, SU60.05, SU60.15, SU60.10 3 refs
I, IIa
MDR
Website
info@inspital.com
EUDAMED record
Report an error
Italeco
Italy
I
MDR
Website
info@italeco.com
EUDAMED record
Report an error
ITO FDA
EU representative : MDSS GmbH (Germany)
Japan
IIa
93/42
EUDAMED record
Report an error
Ivory
Italy
IIa
93/42
Website
EUDAMED record
Report an error
KAZ Europe Sàrl FDA
EU representative : Obelis s.a. (Belgium)
Switzerland
IIa
MDR, 93/42
Quality_EMEA@helenoftroy.com
EUDAMED record
Report an error
Konfort Ozel Saglik Hizmetleri Tibbi Malz San Ve Tic Sti
Türkiye
IIa, IIb
93/42
Website
info@confortostomi.com
EUDAMED record
Report an error
Koninklijke Utermöhlen FDA
Netherlands
IIa
93/42
Website
info@utermohlen.nl
EUDAMED record
Report an error
Ksyos
Netherlands
I
MDR
Website
EUDAMED record
Report an error
La Diffusion Technique Française
France
IIa
93/42
EUDAMED record
Report an error
Lasotronix
Poland
IIb
93/42
EUDAMED record
Report an error
Leinzett
EU representative : Caretechion GmbH (Germany)
China
I, IIa
MDR, 93/42
info@leinzett.com
EUDAMED record
Report an error
Liability Research Production Enterprise Dх-Systems
EU representative : Nilas MV GmbH (Germany)
Ukraine
IIa
93/42
Website
EUDAMED record
Report an error
Lynmou
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
Image Processor for Medical Endoscopy VC-1800Pro, VC-1800, VC-1800Elite, VC-1700Pro, VC-1700, VC-1700Elite, VC-1600Pro, VC-1600, VC-1600Elite, VC-1000Pro, VC-1000, VC-1000Elite, VC-880Pro, VC-880, VC-880Elite, VC-800Pro, VC-800, VC-800Elite, etc. 3 refs Light Source for Medical Endoscopy LS-10, LS-10Core, etc. 3 refs Video Colonoscope EC-10, EC-10L, EC-10S, EC-10P, EC-10PL, EC-10T, EC-10TL, EC-10TS, etc. 3 refs Video Gastroscope EG-10, EG-10T, EG-10XT, etc. 3 refs
I, IIa
MDR
EUDAMED record
Report an error
M.I.S.S. Medizintechnik
Germany
IIa
MDR, 93/42
EUDAMED record
Report an error
M4Medical
Poland
IIa
93/42
Website
EUDAMED record
Report an error
MAG & More FDA
Germany
IIa
MDR
Website
support@magandmore.com
EUDAMED record
Report an error
MAKO Surgical FDA
EU representative : Stryker European Operations Limited (Ireland)
United States
IIa
MDR
Website
EUDAMED record
Report an error
MDT Micro Diamond Technologies FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
MDR
Website
info@mdtdental.com
EUDAMED record
Report an error
Meccanottica Mazza
Italy
I
MDR
info@meccanotticamazza.it
EUDAMED record
Report an error
Mectron FDA
Italy
I, IIa
MDR
Website
EUDAMED record
Report an error
medical equipment europe
Germany
IIa
93/42
Website
info@smartpft.com
EUDAMED record
Report an error
Medical Filtration Solutions
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
93/42
EUDAMED record
Report an error
Medical Technology Transfer Services
EU representative : Logic S.r.l. (Italy)
Vietnam
IIa, IIb
MDR
Website
info@mtts-asia.com
EUDAMED record
Report an error
MEDIconet
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Medimaging Integrated Solution FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
I, IIa
MDR
ra@miis.com.tw
EUDAMED record
Report an error
Meditec Source FDA
Germany
BOHRER Ø 2,7MM Spiralbohrer Ø2,2/1,1mm, durchbohrt, Länge 100/75mm, für Schnellkupplung 3 refs Führungsdraht Ø 1.0 mm, mit Gewindespitze, Länge 100 mm Führungsdrähte 3 refs Gewindeschneider Ø2,0, für Schnellkupplung 3 refs KOPFRAUMFRÄSER CS 28/3 3 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
Merz Medizintechnik
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Metrax
Germany
IIb, III
MDR, 93/42
vigilance@primedic.com
EUDAMED record
Report an error
Micro Intelligent Technology (Hunan)
EU representative : Everbiz GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
MicroTech Medical (Hangzhou)
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Ml Elettromedicali
Italy
IIa
93/42
Website
EUDAMED record
Report an error
Monitex FDA
EU representative : MedPath GmbH (Germany)
Taiwan
I
MDR
Website
EUDAMED record
Report an error
Moria FDA
France
IIa
93/42
EUDAMED record
Report an error
Multiradiance FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Nadeemsurgical
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
info@nadeemsurgical.com
EUDAMED record
Report an error
Nantong Haochuan Industry FDA
EU representative : HUMISS TRADING S. L. (Spain)
China
I
MDR
EUDAMED record
Report an error
Nefmed medikal ürünleri inşaat otomotiv dış ticaret A.Ş
Türkiye
IIa
93/42
Website
info@nefmedical.com
EUDAMED record
Report an error
neuroConn FDA
Germany
I, IIa
MDR
Website
info@neurocaregroup.com
EUDAMED record
Report an error
Neuroelectrics FDA
Spain
I, IIa
MDR, 93/42
Website
info@neuroelectrics.com
EUDAMED record
Report an error
Neurovirtual FDA
EU representative : Obelis s.a. (Belgium)
United States
IIa
MDR
Website
info@neurovirtual.com
EUDAMED record
Report an error
Nexstim FDA
Finland
IIa
MDR, 93/42
Website
info@nexstim.com
EUDAMED record
Report an error
Ningbo Xinwell Medical Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I, IIa
MDR
EUDAMED record
Report an error
Ningbo Youjoy Dental Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
BES23L,BES18L,BES16L,BES12L,BES8L,CAL23L, CAL18L,CAL16L,CAL12L,CAL8L 3 refs BES45L, BES29L, CAL45L, CAL29L 3 refs BES5L, CAL5L 2 refs Ease-01, Ease-02, Ease-03 DU-11, DU-22, DU-33 3 refs
IIa
MDR
ra01@runyes.com
EUDAMED record
Report an error
Normagrup
Spain
IIb
MDR
Website
eudamed@normagrup.com
EUDAMED record
Report an error
Odiotek
Türkiye
I
MDR
Website
info@odiotek.com
EUDAMED record
Report an error
Oezpinar
Germany
I
MDR
Website
EUDAMED record
Report an error
Ohhmed
EU representative : G&D&Y (Netherlands)
Israel
IIa
MDR
Website
info@vertica-labs.com
EUDAMED record
Report an error
Ormedi Incorporation
EU representative : Kingsmead Service B.V. (Netherlands)
Taiwan
I
MDR
EUDAMED record
Report an error
Oxytek Medical Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIb
MDR, 93/42
administrator@oxtm-o2.cn
EUDAMED record
Report an error
Philipp Kirsch FDA
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Photon Therapy Systems (Pty) FDA
EU representative : TNMC Devices Llc (Croatia)
South Africa
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Physiomed FDA
Germany
I, IIa
MDR
Website
info@physiomed.de
EUDAMED record
Report an error
Physion
Italy
IIa
MDR, 93/42
info@physion.it
EUDAMED record
Report an error
Piomic
EU representative : EUMEDIQ GmbH (Germany)
Switzerland
I, IIa
MDR
Website
info@piomic.com
EUDAMED record
Report an error
PRP Science
EU representative : Meridius Medical Europe Limited (Ireland)
South Korea
III
93/42
Website
EUDAMED record
Report an error
Ramed
Czechia
I
MDR
Website
raska@ramed.cz
EUDAMED record
Report an error
Remed FDA
EU representative : Obelis s.a. (Belgium)
South Korea
BrainStim, TAMAS, ALTMS 3 refs COMPACT-II, ExMS-A, PERFECT, SALUS-TALENT-A, SALUS-TALENT-A8, SALUS-TALENT-Pro, SALUS-TALENT-Pro-Aes, UI CUBE, UI CUBE(H) 3 refs FSWT-A SALUS-ESWT-EXPERT, SLAUS-FSWT, RSWT-A 3 refs ZTone
IIa, IIb
MDR
EUDAMED record
Report an error
RespiraSource, OPC
EU representative : Obelis s.a. (Belgium)
Philippines
I
MDR
Website
info@resplabs.com
EUDAMED record
Report an error
RFH - Rehatechnik
Germany
I
MDR
Website
EUDAMED record
Report an error
Sarstedt FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Schaerer Medical FDA
EU representative : Intelleg Management GmbH (Germany)
Switzerland
I
MDR
Website
info@schaerermedical.ch
EUDAMED record
Report an error
Schulze & Böhm
Germany
IIa
93/42
info@medisun.de
EUDAMED record
Report an error
seca FDA
Germany
IIa
MDR
info@seca.com
EUDAMED record
Report an error
Shandong Deman Medical Equipment Group FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shanghai No.2 Medical College Duhang Medical Equipment Factory
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
China
DL-LED DL-LED,DL-LED-A6/6(X),DL-LED-A6/5(X),DL-LED-A5/5(X),DL-LED-A6(X),DL-LED-A5(X),DL-LED-B6(X),DL-LED-B5(X), DL-LED-A6/6(L1), DL-LED-A6/5(L1), DL-LED-A5/5(L1), etc 3 refs SnBase9900, SnBase8900, SnBase7700, SnBase7600, SnBase7500, SnBase7300, SnBase7100, SnMot7800, SnMot7700, SnMot7500a, SnMot7500b, SnMot7500c, SnMot7300, SnMot7100, SnMot6700, SnMot5100, SnMot5200, SnMot5300, SnMot5500, SnMot5600, SnMot5700 3 refs SnMech3701, SnMech3702, SnMech3100, SnMech3703(Z), SnMech3703(F), SnMech3704, SnMech3705(Z), SnMech3705(F), SnMech3708, SnMech3709, SnMech3710, SnMech3711, SnMech3712 2 refs
I
MDR
EUDAMED record
Report an error
Shanghai Wonderful Opto-Electrics Tech FDA
EU representative : Medwheat Tech Service GmbH (Germany)
China
IIb
93/42
Website
regulatory@wonderful-sh.com
EUDAMED record
Report an error
Shenzhen Jamr Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
RA.dept@jamrmed.com
EUDAMED record
Report an error
Shenzhen JunYuan Medical Equipment FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Shenzhen Ruiankang Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR, 93/42
RAK@szkia.cn
EUDAMED record
Report an error
Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
Poland
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Sinocare FDA
EU representative : Obelis s.a. (Belgium)
China
IIb
MDR
RA@sinocare.com
EUDAMED record
Report an error
Sol Group Lab
Italy
I, IIa, IIb
MDR
Website
info@solgrouplab.it
EUDAMED record
Report an error
Sooil FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Speciální Medicínská Technologie, s.r.o
Czechia
IIb
93/42
Website
info@smt-praha.com
EUDAMED record
Report an error
Spectrum Medical FDA
EU representative : Spectrum Medical S.r.l. (Italy)
United Kingdom (ex Northern Ireland)
I, IIb
MDR
Website
regulatory@spectrummedical.com
EUDAMED record
Report an error
SPIGGLE & THEIS Medizintechnik FDA
Germany
I, IIa
MDR, 93/42
Website
info@spiggle-theis.com
EUDAMED record
Report an error
Stripmed
EU representative : JOYSUN GROUP S.L.U (Spain)
China
I
MDR
info.strip@stripmed.com
EUDAMED record
Report an error
SWS Hemodialysis Care
EU representative : MedPath GmbH (Germany)
China
IIb
MDR, 93/42
EUDAMED record
Report an error
Tedisel
Spain
I, IIb
MDR, 93/42
Website
info@tedisel.com
EUDAMED record
Report an error
Terumo FDA
EU representative : TERUMO EUROPE N.V. (Belgium)
Japan
IIb
93/42
Eudamed_LAA@terumo.co.jp
EUDAMED record
Report an error
Thought Technology FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
I
MDR, 93/42
Website
EUDAMED record
Report an error
Timesco FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
regulatory@timesco.com
EUDAMED record
Report an error
Tonglu Youshi Medical Instrument FDA
EU representative : MedPath GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Toruscare
Poland
I
MDR
EUDAMED record
Report an error
Tosi Foshan Medical Equipment
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
93/42
EUDAMED record
Report an error
Towardpi
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
Ophthalmic Optical Coherence Tomography Systems BM-400K Ultra, BM-400K MAX, BM-400K NF, BM-400K, BM Lite 3 refs Ophthalmic Optical Coherence Tomography Systems YG-100K Ultra, YG-100K MAX, YG-100K NF, YG-100K PRO, YG Lite 3 refs Ophthalmic Optical Coherence Tomography Systems YG-250K Ultra, YG-250K NF 2 refs Swept-source Optical Biometer ZW-30 MAX, ZW-30 TP 2 refs
IIa
MDR
RA@towardpi.com
EUDAMED record
Report an error
Trautwein
Germany
I
MDR
Website
info@trautwein-gmbh.com
EUDAMED record
Report an error
Tse
Czechia
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Tuylek
Spain
IIa
93/42
Website
info@keito.com
EUDAMED record
Report an error
Unimicromed
EU representative : Wellkang Ltd (Northern Ireland)
China
Single-Use Flexible Bronchoscope UNEN-BC20A 3 refs UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E 3 refs UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E 3 refs UNP100, UNP200 2 refs
IIa
MDR
Website
EUDAMED record
Report an error
Unitekno
Italy
IIa
93/42
Website
info@unitekno.com
EUDAMED record
Report an error
UroViu FDA
EU representative : Casus Europe B.V. (Netherlands)
United States
I
MDR
Website
cs@uroviu.com
EUDAMED record
Report an error
Utastech
Slovakia
IIb
93/42
Website
info@utastech.eu
EUDAMED record
Report an error
Vasomedical FDA
EU representative : phoenix Medtech GmbH (Germany)
United States
IIa
MDR
EUDAMED record
Report an error
VIOL Medical FDA
EU representative : AR Experts B.V. (Netherlands)
South Korea
IIb
MDR, 93/42
EUDAMED record
Report an error
Wagner & Guder Medical
Germany
I
MDR
Website
info@wagner-guder-medical.de
EUDAMED record
Report an error
Weihai Weibo Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
Website
EUDAMED record
Report an error
WEINMANN Emergency Medical Technology FDA
Germany
IIb
MDR, 93/42
Website
info@weinmann-emt.de
EUDAMED record
Report an error
Won Tech FDA
EU representative : mdi Europa GmbH (Germany)
South Korea
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Wuxi Medical Instrument Factory FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Yaklaşim Maki̇na Sanayi̇ Ve Ti̇caret Şi̇rketi̇
Türkiye
IIb
93/42
Website
EUDAMED record
Report an error
Zehnit
EU representative : Lotus NL B.V. (Netherlands)
China
I, IIa
MDR
Website
info@zehnit.cn
EUDAMED record
Report an error
ZMI Electronics FDA
EU representative : mdi Europa GmbH (Germany)
Taiwan
I
MDR
Website
mail@zmi-electronics.com
EUDAMED record
Report an error
Medtrum
EU representative : Medtrum B.V. (Netherlands)
China
15 others
IIa, IIb
MDR, 93/42
info@medtrum.com
EUDAMED record
Report an error
Potec FDA
EU representative : MDSS GmbH (Germany)
South Korea
PACP-8000, TCP-4042, Rodachart 422 3 refs PDR-7000, TAP-2000, Phoromat 2000 3 refs PLC-8000, PLC-8000pola, TCP-4000, TCP-4000P, CV 600, CV 800P, PLC-9000, PLC-9000pola 3 refs PRK-5000 93/42 (no longer marketed) PRK-6000 93/42 (no longer marketed) 2 others
I
MDR, 93/42
Website
EUDAMED record
Report an error
Axess Vision Technology FDA
France
I, IIa
MDR, 93/42
Website
raqa.ptm@tsc-group.com
EUDAMED record
Report an error
GME German Medical Engineering FDA
Germany
IIb
MDR, 93/42
Website
info@gmeonline.de
EUDAMED record
Report an error
Accutargetmed
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Accutron FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
IIa, IIb
93/42
EUDAMED record
Report an error
Activ Surgical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIa
MDR
Website
info@activsurgical.com
EUDAMED record
Report an error
Advitos
Germany
IIb
MDR
Website
info@advitos.com
EUDAMED record
Report an error
Akern
Italy
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Aksdent
Türkiye
IIa
MDR
Website
EUDAMED record
Report an error
Alerta Medical FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Alfamedic
Czechia
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Alfamedsrl
Italy
IIa
93/42
Website
info@alfamedsrl.com
EUDAMED record
Report an error
Ampall
EU representative : AR Experts B.V. (Netherlands)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Amsino FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
EUDAMED record
Report an error
Aojmedical FDA
EU representative : Share info GmbH (Germany)
China
IIa
MDR
regulation@aojmedical.com
EUDAMED record
Report an error
Armocon
EU representative : LELOi AB (Sweden)
China
I
MDR, 93/42
EUDAMED record
Report an error
ArthroCare FDA
EU representative : Smith & Nephew Operations BV (Netherlands)
United States
IIb
MDR
eudamed-actor.global@smith-nephew.com
EUDAMED record
Report an error
Arya Teb Firouz
EU representative : Health Tec srl (Italy)
Iran
I, IIa
MDR
Website
EUDAMED record
Report an error
At-Os FDA
Italy
I, IIa, IIb
MDR
Website
EUDAMED record
Report an error
AtCor Medical FDA
EU representative : Advena Limited (Malta)
Australia
IIa
93/42
info@atcormedical.com
EUDAMED record
Report an error
Atlantamed
EU representative : Casus Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIb
93/42
Website
info@atlantamed.co.uk
EUDAMED record
Report an error
axion FDA
Germany
IIa
MDR, 93/42
Website
service@axion-net.de
EUDAMED record
Report an error
Battan International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
EUDAMED record
Report an error
Beijing Eternity Electronic Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
Beijing YAFMED
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Belmont Manufacturing
EU representative : Takara Company Europe GmbH (Germany)
Vietnam
IIa
93/42
EUDAMED record
Report an error
Berchtold
Germany
I
MDR
EUDAMED record
Report an error
BES
Italy
IIb
93/42
info@besitalia.it
EUDAMED record
Report an error
Bestrantech
EU representative : SUNGO Europe B.V. (Netherlands)
China
BT-LED700700B,BT-LED700500B,BT-LED500500B,BT-LED700B,BT-LED500B,BT-LED700700B-TV,BT-LED700500B-TV,BT-LED700BS,BT-LED700BE,BT-LED500BS,BT-LED500BE,BT-LED700BW,BT-LED500BW,BT-LED15S,BT-LED15E,BT-LED25W,BT-LED25,BT-LED255,etc 3 refs BT-RA014,BT-RA015,BT-RA017,BT-RA30,BT-RA31,BT-RA32,BT-RA33,BT-RA36,BT-RA37,BT-RA39,BT-RA50,BT-RA51,BT-RA52,BT-RA53,BT-RA56,BT-RA57,BT-RA58,BT-RA59,BT-RA60,BT-RA62,BT-RA63,BT-RA038 3 refs BT-RA017A,BT-RA018,BT-RA019,BT-RA021,BT-RA022,BT-RA028,BT-RA029,BT-RO02,BT-RO03,BT-RO05,BT-ROB,BT-ROD,BT-ROE,BT-ROF,BT-ROG,BT-ROI,BT-ROJ,BT-ROK,BT-ROL,BT-ROM,BT-RON,BT-ROP,BT-ROQ 3 refs
I
MDR
EUDAMED record
Report an error
Beyondmedi
EU representative : KTR Europe GmbH (Germany)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
bg edelstahl und kunststofftechnik für krankenhaus, industrie und wasserwirtschaft
Germany
IIa
93/42
Website
service@bg-edelstahl.de
EUDAMED record
Report an error
Bibi Surgical Industry
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
EUDAMED record
Report an error
Bio Tech Health medical Supplies(Tianjin)
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Bio-Si International
Italy
IIb
MDR
regulatory@bio-si.it
EUDAMED record
Report an error
Biomedicinos technika
Lithuania
I
MDR
EUDAMED record
Report an error
BODY PRODUCTS RELAX Pharma und Kosmetik
Germany
I
MDR
Website
info@body-products.de
EUDAMED record
Report an error
Boen Healthcare FDA
EU representative : Everbiz GmbH (Austria)
China
I
MDR
Website
EUDAMED record
Report an error
Bohemia - Moor Sro
Czechia
I
MDR
EUDAMED record
Report an error
BPR Swiss
EU representative : Klaus Seiler (Germany)
Switzerland
I, IIa
MDR
Website
info@bpr-swiss.com
EUDAMED record
Report an error
Bryant FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Cadwell FDA
EU representative : AR Experts B.V. (Netherlands)
United States
I, IIa
MDR
Website
info@cadwell.com
EUDAMED record
Report an error
Cardia International
Denmark
IIb
93/42
Website
regulatory@cardiainternational.com
EUDAMED record
Report an error
Cardiolex
Sweden
IIa
MDR
Website
info@cardiolex.se
EUDAMED record
Report an error
Care Essentials FDA
EU representative : Advena Limited (Malta)
Australia
IIb
MDR
Website
EUDAMED record
Report an error
Casio
EU representative : MedNet EC-REP GmbH (Germany)
Japan
I
MDR
info_prrc1-yam@casio.co.jp
EUDAMED record
Report an error
Chirastar
Czechia
IIa
93/42
Website
EUDAMED record
Report an error
ChongQing SS Medical Equipments FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Clinomic
Germany
I, IIa
MDR
Website
info@clinomic.ai
EUDAMED record
Report an error
COMPEX, spol. s r.o FDA
Czechia
IIb
MDR
Website
info@jett.eu
EUDAMED record
Report an error
Concorde Import Export Sarl
France
I
MDR
EUDAMED record
Report an error
Cornerstone Technology (Shenzhen)
EU representative : Cornerstone Robotics B.V. (Netherlands)
China
IIa, IIb
MDR
Website
contact@csrbtx.com
EUDAMED record
Report an error
Creo Medical FDA
EU representative : Creo Medical, S.L.U. (Spain)
United Kingdom (ex Northern Ireland)
IIb
MDR, 93/42
Website
info@creomedical.com
EUDAMED record
Report an error
Curaway FDA
EU representative : Prolinx GmbH (Germany)
China
IIb
MDR
sales@curaway.com
EUDAMED record
Report an error
Curexo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Cyberdyne FDA
EU representative : Cyberdyne Care Robotics GmbH (Germany)
Japan
IIa
MDR
regulatory_affairs@cyberdyne.jp
EUDAMED record
Report an error
Daejumedi FDA
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Delmont imaging
France
I, IIa
MDR
Website
contact@delmont-imaging.com
EUDAMED record
Report an error
Dental Devices
EU representative : AR Experts B.V. (Netherlands)
Israel
IIa
MDR
Website
Ra@ab-dent.com
EUDAMED record
Report an error
DentalMaster(Xiamen) Medical Technology
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Dentmate FDA
EU representative : KOMAS Medical Technology GmbH (Germany)
Taiwan
I
MDR
Website
info@dentmate.com.tw
EUDAMED record
Report an error
Dewimed FDA
Germany
I, IIa
MDR
Website
info@dewimed.de
EUDAMED record
Report an error
Dia-Med Egészségügyi És Gépészeti Berendezéseket Gyártó És Forgalmazó Kft
Hungary
I
MDR
Website
EUDAMED record
Report an error
Disposafe FDA
EU representative : AR Experts B.V. (Netherlands)
India
I
MDR, 93/42
EUDAMED record
Report an error
Dong Guan Gang Mei Optical FDA
EU representative : INDIAN EYEWEAR MADRID S.L. (Spain)
China
I
MDR
EUDAMED record
Report an error
Dr. Mach FDA
Germany
I
MDR
Website
info@dr-mach.de
EUDAMED record
Report an error
Dudek Innovations Spółka Z Ograniczoną Odpowiedzialnością
Poland
I
MDR
EUDAMED record
Report an error
E-Swin FDA
France
IIa
93/42
Website
contact@e-swin.com
EUDAMED record
Report an error
Easymed FDA
EU representative : mdi Europa GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Eclipse Prism Medical Devices
EU representative : Mars Medical (Germany)
India
I
MDR
Website
info@epmdgroup.com
EUDAMED record
Report an error
Ekal
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
EKU Elektronik
Germany
IIb
93/42
Website
info@eku-elektronik.de
EUDAMED record
Report an error
Ellegimedical
Italy
I
MDR
Website
EUDAMED record
Report an error
Elmaslar İmalat Tibbi̇ Ci̇hazlar İnş. Taş.İth.İhr.San. Ve Ti̇c.A.Ş
Türkiye
HEALTHTIME OC5, HEALTHTIME OC10, OXYTIME Q5 93/42 NEBTIME UN600A, NEBTIME UN300A, NEBTIME UN700, FLEXOR UN01, SKYCELL UN01, FLYMIST UN01, UPWELL UN01, ELİTE UN01 93/42 SA 01 HT, SA 02 HT, SA 03 HT, SA 04 HT, SA 05 HT, SA 06 HT, SA 01 PT , SA 02 PT , SA 03 PT , SA 04 PT , SA 05 PT , SA 06 PT , SA 03 PT2, SA 01 PB , SA 02 PB , SA 03 PB , SA 04 PB , SA 05 PB , SA 06 PB , SA 04 PB1 93/42
IIa
93/42
Website
info@elmaslarmedikal.com.tr
EUDAMED record
Report an error
Embitron
Czechia
IIa
93/42
Website
EUDAMED record
Report an error
EMED Technologies FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
customerservice@emedtc.com
EUDAMED record
Report an error
Endocraftllc FDA
EU representative : MediMark Europe Sarl. (France)
United States
I
MDR
Website
info@endocraft-llc.com
EUDAMED record
Report an error
Endoteq
Germany
IIb
93/42
Website
info@endoteq.de
EUDAMED record
Report an error
EOVE
France
IIb
MDR
contact@eove.fr
EUDAMED record
Report an error
Equa
Estonia
I
MDR
Website
info@equa.ee
EUDAMED record
Report an error
Escomedical
EU representative : MedPath GmbH (Germany) and 1 other
China
I, IIa, IIb
MDR, 93/42
sales@escomedical.com.cn
EUDAMED record
Report an error
Etkintibbi
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Eufoton FDA
Italy
I, IIb
MDR
Website
info@eufoton.it
EUDAMED record
Report an error
Excel-Lens FDA
EU representative : ELS SOLUTIONS GDIA - UNIPESSOAL LDA. (Portugal)
United States
IIb
93/42
Website
EUDAMED record
Report an error
Ezisurg FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR
Website
ra@ezisurg.com
EUDAMED record
Report an error
Famidoc FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Faset
Italy
IIa
MDR
EUDAMED record
Report an error
Fesia technology
Spain
IIa
MDR
Website
EUDAMED record
Report an error
FineMEC FDA
EU representative : MDSS GmbH (Germany)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Fomos FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
93/42
EUDAMED record
Report an error
Fortunemed FDA
EU representative : Emergo Europe B.V. (Netherlands)
Taiwan
IIa
93/42
EUDAMED record
Report an error
Fresenius Medikal Hizmetler A.Ş
Türkiye
IIb
MDR
Website
info.turkey@fmc-ag.com
EUDAMED record
Report an error
Galbiati
Italy
IIa, IIb
93/42
Website
info@galbiati.com
EUDAMED record
Report an error
Genial FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
admin@genial.cn
EUDAMED record
Report an error
Globalcare FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
China
IIa
MDR
info@globalcare.com.hk
EUDAMED record
Report an error
Grundfos
Italy
IIb
MDR
Website
EUDAMED record
Report an error
Grupdental
Türkiye
IIa
93/42
Website
EUDAMED record
Report an error
Gtec FDA
Austria
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Guangxi Visualtech S&T
EU representative : Eunitor GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Guangzhou Ajax Medical Equipment FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
AJ10, AJ11, AJ12, AJ15, AJ16, AJ17, AJ18, AJ19, AJ22, AJ25, AJ26, AJ28 LED dental light Orion, Hubble, Hubble II, Amber, Amber II, Pebble, Pebble II, Leo, Libra 3 refs Operating Table AA6688
I, IIa
MDR
EUDAMED record
Report an error
Guangzhou AXD Electronic
EU representative : Eunitor GmbH (Germany) and 1 other
China
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Guangzhou Renlai Rehabilitation Equipment Manufacturing
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Gulden Ophthalmics FDA
EU representative : QbD RepS BV (Belgium)
United States
I
MDR
Website
info@guldenophthalmics.com
EUDAMED record
Report an error
Hangzhou Tingoton Technology
EU representative : Humiss Beratung GmbH (Germany)
China
Audioline-OTOVideo(Intelligent Digital Otoscope) QZ100, QZ101, QZ102, QZ103, QZ104, QZ105, QZ106, QZ107, QZ108 2 refs Disposable Ear Specula Soundproof Booth TRA10, TRA15, TRA20, TRA25, TRA30,TRA35,TRA40,TRA45,TRA50,TRB10,TRB15,RB20,TRB25, TRB30, TRB35, TRB40, TRB45, TRB50, TRC10, TRC15, TRC20, TRC25, TRC30,TRC35,TRC40,TRC45,TRC50,TRD25, TRD30, TRD35, TRD40, TRD45,TRD50,TRE25,TRE30,TRE35,TRE40,TRE45,TRE50
I
MDR
EUDAMED record
Report an error
Hangzhou Zhengda Medical FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Hasharon Dental Center
EU representative : Obelis s.a. (Belgium)
Israel
IIa
MDR
Website
Info@Hasharon-Dental.com
EUDAMED record
Report an error
Hearx Pty FDA
EU representative : Advena Limited (Malta)
South Africa
I, IIa
MDR
Website
compliance@hearxgroup.com
EUDAMED record
Report an error
Hebei inheritance Xiaoai Medical Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
XA-LED500, XA-LED700, XA-LED700/500, XA-LED700/500A, XA-LED700/700, XA-LED700/700A, XA-LED600/600, XA-LED600/600A, XA-LED600/500, XA-LED600/500A, XA-LED500/500, XA-LED500/500A, XA-500,XA-700, etc. XA-OT01, XA-OT02,XA-OT03,XA-OT04, XA-OT05,XA-OT06, XA-OT07, XA-OT08, XA-OT09, XA-OT10,XA-OT11, XA-OT12 XA-OTD01, XA-OT02,XA-OT03,XA-OT04, XA-OT05,XA-OT06, XA-OT07, XA-OT08, XA-OT09, XA-OT10,XA-OT11, XA-OT12
I
MDR
EUDAMED record
Report an error
Hefei Health Science Technology Development
EU representative : SUNGO Europe B.V. (Netherlands)
China
LEDD700/700,LEDD700,LEDD620/620,LEDD620,LEDD500/500,LEDD500,LEDD700/500,LEDD730/730,LEDD730,LEDD740/740,LEDD740,LEDD730/740,LEDD260/260,LEDD260,LEDD200/200, LEDD200,LEDB700,LEDB620,LEDB500,LEDB730,LEDB740,etc 3 refs TDG-1,TDG-2,TDY-1,TDY-2,TDY-G-1,TDY-Y-1,TDY-Y-2,FD-G-1,FD-G-2 3 refs TS ,TS-1 ,TY ,TF ,TG 3 refs
I
MDR
EUDAMED record
Report an error
Heidelberg Engineering FDA
Germany
IIa
MDR
EUDAMED record
Report an error
Heuser Apparatebau
Germany
I, IIa
MDR
Website
info@heuser-haan.de
EUDAMED record
Report an error
HLS Hypertech Laser Systems
Germany
IIa
93/42
Website
info@hypertech-lasers.de
EUDAMED record
Report an error
Hospital Technical Solutions
Romania
IIb
93/42
Website
EUDAMED record
Report an error
Hs Doms
Germany
I
MDR
Website
info.doms@haag-streit.com
EUDAMED record
Report an error
HuBDIC FDA
EU representative : S.B. Pharma GmbH (Germany)
South Korea
IIa
MDR
EUDAMED record
Report an error
Hunan Reborn Medical Science Technology Development
EU representative : MedPath GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Hunan Yueguang Medical Technology
EU representative : Share info GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Huons Meditech
EU representative : KTR Europe GmbH (Germany)
South Korea
IIb
93/42
EUDAMED record
Report an error
I-Tech Industries FDA
Italy
IIa
MDR
Website
info@i-techindustries.com
EUDAMED record
Report an error
I.C. Medical FDA
EU representative : MDSS GmbH (Germany)
United States
I, IIa
MDR
Website
inquiry@icmedical.com
EUDAMED record
Report an error
I.C.LERCHER-Solutions FDA
Germany
I
MDR
info@icl-s.de
EUDAMED record
Report an error
IEM FDA
Germany
IIa
MDR, 93/42
regulatory@iem.de
EUDAMED record
Report an error
Inosystems FDA
France
IIb
MDR, 93/42
contact@inosystems.fr
EUDAMED record
Report an error
Invamed FDA
Türkiye
IIa
93/42
Website
EUDAMED record
Report an error
Irradia
Sweden
IIa
MDR
Website
info@irradia.se
EUDAMED record
Report an error
Itaka way med
Italy
I
MDR
Website
EUDAMED record
Report an error
Itamar Medical FDA
EU representative : Arazy Group GmbH (Germany)
Israel
IIa
MDR
Website
customersupportrow@zoll.com
EUDAMED record
Report an error
iVis Technologies
Italy
IIb
93/42
Website
EUDAMED record
Report an error
J. Morita Tokyo Mfg
EU representative : J. MORITA EUROPE GMBH (Germany)
Japan
IIa
93/42
vigilance@jmtmc.co.jp
EUDAMED record
Report an error
Jiangsu Jingyi Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Jiangsu Jiyuan Medical Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other
China
I, IIa
MDR
EUDAMED record
Report an error
Jiangsu Mole Electronic Technology FDA
EU representative : phoenix Medtech GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Jörg & Sohn FDA
Germany
I
MDR
Website
info@joergundsohn.de
EUDAMED record
Report an error
Keymed Medical Industrial Equipment
EU representative : Olympus Europa SE & Co. KG (Germany)
United Kingdom (ex Northern Ireland)
I, IIa
MDR
EUDAMED record
Report an error
Kingyield FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
BP101B, BP101E, BP101G, BP101H, BP101K, BP101N, BP101W, BP101Y, BP101U, BPx2, BP101D 3 refs BP204, BP205, BP220, BP309A, BP308A, BP308B, BP310A, BP310B, BP207 3 refs BPW1, BPW2, BPW3, BPW5, BPW6 3 refs
IIa
MDR
EUDAMED record
Report an error
Kirmed International
Italy
IIb
MDR
info@kirmedinternational.com
EUDAMED record
Report an error
Klsmartin FDA
Germany
I, IIa, IIb
MDR, 93/42
Website
vigilance@klsmartin.com
EUDAMED record
Report an error
KP Medical
EU representative : SMEDTEC OÜ (Estonia)
United Kingdom (ex Northern Ireland)
I
MDR
Website
regulatory@zimadental.co.uk
EUDAMED record
Report an error
Kroeber
Germany
IIb
93/42
Website
EUDAMED record
Report an error
Laerdal FDA
Norway
IIa
93/42
Website
PRRC@laerdal.com
EUDAMED record
Report an error
LaproSurge
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I, IIa
93/42
Website
info@laprosurge.com
EUDAMED record
Report an error
Laser Light Orvostechnikai Innovációs Kft
Hungary
IIa
93/42
Website
EUDAMED record
Report an error
Linaus
Italy
I
MDR
Website
info@linaus-md.com
EUDAMED record
Report an error
Lintemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Littlesparrowstech FDA
EU representative : CEpartner4U (Netherlands)
United States
I, IIa
MDR
Website
info@littlesparrowstech.com
EUDAMED record
Report an error
Magillmed FDA
EU representative : Share info GmbH (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
Mandelay Magyarország Kft
Hungary
IIa
93/42
Website
info@vibeyoup.com
EUDAMED record
Report an error
Maquet Cardiopulmonary FDA
Germany
IIb
MDR, 93/42
raop.cp@getinge.com
EUDAMED record
Report an error
Maquet Critical Care FDA
Sweden
IIb
MDR
EUDAMED record
Report an error
Masmec FDA
Italy
I, IIa
93/42
Website
EUDAMED record
Report an error
Maxtec FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIa, IIb
MDR
Website
customerservice@salaera.com
EUDAMED record
Report an error
Med & Life
Poland
IIa
93/42
Website
EUDAMED record
Report an error
Med-Logix
Italy
IIb
MDR
Website
info@medlogix.eu
EUDAMED record
Report an error
MedEvolve
EU representative : RS Consultancies (Netherlands)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Medilogic FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Meditrac FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Israel
I
MDR
Website
info@meditrac.co.il
EUDAMED record
Report an error
Medivators FDA
EU representative : STERIS Ireland Ltd (Ireland)
United States
IIa, IIb
93/42
Website
EUDAMED record
Report an error
MEDWIN France FDA
France
IIa
MDR
contactmedwin@vygon.com
EUDAMED record
Report an error
Megin FDA
Finland
IIa
93/42
Website
qara@megin.fi
EUDAMED record
Report an error
MEIKO Maschinenbau FDA
Germany
IIa
MDR
Website
info@meiko-global.com
EUDAMED record
Report an error
Meise
Germany
IIa
93/42
mail@meise.com
EUDAMED record
Report an error
Memscap FDA
Norway
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Merivaara
Finland
I
MDR
Website
EUDAMED record
Report an error
Metasys
Austria
I
MDR
Website
info@metasys.com
EUDAMED record
Report an error
Meyosis
Türkiye
I
MDR
Website
info@meyosis.com
EUDAMED record
Report an error
Micro Therapeutics D B A Ev3 Neurovascular FDA
EU representative : Medtronic B.V. (Netherlands)
United States
I, IIa
MDR
EUDAMED record
Report an error
Miltenyi
Germany
IIb
MDR
RA_Registrator@miltenyi.com
EUDAMED record
Report an error
Ml Fusion
France
I
MDR
Website
EUDAMED record
Report an error
Monath-Electronic
France
I
MDR
servicequalite@monath-electronic.fr
EUDAMED record
Report an error
MPS Micro Precision Systems FDA
EU representative : Emergo Europe B.V. (Netherlands)
Switzerland
IIa
MDR
Website
customers@mpsag.com
EUDAMED record
Report an error
Mrc Systems Medizintechnische Systeme FDA
Germany
I
MDR
Website
info@mrc-systems.de
EUDAMED record
Report an error
Munich Surgical Imaging FDA
Germany
I, IIa
MDR
Website
info@munichimaging.de
EUDAMED record
Report an error
Nanchang Woek Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Nanoomtech
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Narang FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
I
MDR
Website
EUDAMED record
Report an error
Naturelle
Northern Ireland
I, IIa
MDR
Website
customerservices@naturelle.ie
EUDAMED record
Report an error
NCCMedical Pte
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Singapore
IIa
MDR
EUDAMED record
Report an error
NeuroDerm
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Israel
IIb
MDR
info@neuroderm.com
EUDAMED record
Report an error
Neuromed
France
IIa
MDR
Website
EUDAMED record
Report an error
NeurOptics FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
93/42
Website
EUDAMED record
Report an error
Ningbo Greetmed Medical Instruments FDA
EU representative : MedPath GmbH (Germany)
China
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Nomics
Belgium
IIa
93/42
Website
sales@nomicscare.com
EUDAMED record
Report an error
NonDolens
Germany
IIa
93/42
Website
mail@nondolens.com
EUDAMED record
Report an error
Novavision
Italy
IIa
93/42
Website
info@novavision.net
EUDAMED record
Report an error
NuStep
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
NuvoAir FDA
Sweden
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Ohira
EU representative : Rexxam Co., Ltd. Netherlands Office (Netherlands)
Japan
I
MDR
Website
EUDAMED record
Report an error
Opsens FDA
EU representative : MDSS GmbH (Germany)
Canada
IIa, IIb
MDR, 93/42
RegulatoryEurope@Haemonetics.com
EUDAMED record
Report an error
Orthokey FDA
Italy
I, IIa
MDR, 93/42
quality.assurance@orthokey.eu
EUDAMED record
Report an error
Orthosxxi
Portugal
I
MDR
Website
info@orthosxxi.com
EUDAMED record
Report an error
OT Bioelettronica
Italy
I
MDR
Website
EUDAMED record
Report an error
Oxyvein
Türkiye
IIb
93/42
Website
info@oxyvein.com
EUDAMED record
Report an error
Pacific Consolidated Industries
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
93/42
EUDAMED record
Report an error
Plasmabiotics
France
I
MDR
Website
contact@plasmabiotics.com
EUDAMED record
Report an error
Poly Medicure FDA
EU representative : Obelis s.a. (Belgium)
India
I, IIa
MDR
Website
ramdas@polymedicure.com
EUDAMED record
Report an error
Prime Dental Products
EU representative : Obelis s.a. (Belgium)
India
I
MDR
Website
EUDAMED record
Report an error
Profound Medical FDA
EU representative : MDSS GmbH (Germany)
Canada
IIb
MDR, 93/42
info@profoundmedical.com
EUDAMED record
Report an error
Progetti
Italy
IIb
93/42
Website
info@progettimedical.com
EUDAMED record
Report an error
Promed FDA
Italy
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Provita FDA
Germany
I
MDR
Website
info@provita.de
EUDAMED record
Report an error
Proxinse
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
EUDAMED record
Report an error
PSI Plus FDA
EU representative : SMGeurope OÜ (Estonia)
South Korea
I
MDR
EUDAMED record
Report an error
Pu Yuan Biotech
EU representative : Obelis s.a. (Belgium)
Taiwan
IIa
93/42
Website
service@puyuan-bio.com
EUDAMED record
Report an error
P³Lab
Belgium
I, IIa
MDR
Website
info@neuroclues.com
EUDAMED record
Report an error
Raydentinst
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
I
93/42
Website
info@raydentinst.com
EUDAMED record
Report an error
Reimers & Janssen
Germany
IIa
MDR
Website
service@rj-laser.com
EUDAMED record
Report an error
RF Medical FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
MDR
Website
EUDAMED record
Report an error
Rstmedikal
Türkiye
IIa, IIb
MDR
Website
info@rstmedikal.com
EUDAMED record
Report an error
Ruian Sunnyworld International Trade FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
OPHTHALMOSCOPE SW-OT15,SW-OT15S,SW-OT15R， SW-OT15F,SW-OT15C,SW-OT15LC OTOSCOPE SW-OT16, SW-OT16J,SW-OT16N, SW-OT16S,SW-OT16L,SW-OT16R， SW-OT16F,SW-OT16C,SW-OT16LC， SW-OT03,SW-GP06,SW-OT11, SW-GP09B,SW-GP09C,SW-GP20 PENLIGHT SW-PL01,SW-PL07,SW-PL16, SW-45,SWPL48,SW-PL49, SW-PL78 3 refs
I
MDR
rashengweide@outlook.com
EUDAMED record
Report an error
Saalmann medical FDA
Germany
I, IIa
MDR
Website
info@saalmann-medical.de
EUDAMED record
Report an error
Sanasol
Hungary
–
98/79
Website
info@mail.sanasol.hu
EUDAMED record
Report an error
Satellite
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
EUDAMED record
Report an error
Scaleo Medical
France
IIa
93/42
Website
Info.fr@scaleomedical.com
EUDAMED record
Report an error
Schiller Healthcare India
EU representative : SCHILLER MEDICAL (France)
India
I, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Schuelke
Germany
IIb
MDR
Website
info@schuelke.com
EUDAMED record
Report an error
Sensingfuture
Portugal
I
MDR
info@sensingfuture.pt
EUDAMED record
Report an error
Shandong Horo Medical Equipment
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Shanghai Bolan Optical Electric FDA
EU representative : Lotus NL B.V. (Netherlands) and 1 other
China
BL-16，BL-17，BL-19 2 refs BL-99D ,BL-99C ,BL-99 ,BL-99T,BL-9A ,BL-9AT,BL-88D ,BL-88 ,BL-88T,BL-6A ,BL-66B ,BL-66A ,BL-5000 ,BL-5100 3 refs BOLAN BL-5000 93/42
I
MDR, 93/42
Website
sales1@sh-bolan.com
EUDAMED record
Report an error
Shanghai Huvitz FDA
EU representative : LGMed Trades Oy (Finland)
China
I
MDR
Website
EUDAMED record
Report an error
Shanghai INT Medical Instruments FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR, 93/42
EUDAMED record
Report an error
Shanghai PAX Medical Instrument FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Shenyang RMS Medical Tech
EU representative : MedPath GmbH (Germany)
China
IIa, IIb
MDR
EUDAMED record
Report an error
ShenZhen Bi-rich Medical Devices FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I, IIa
MDR
EUDAMED record
Report an error
Shenzhen PRO HITU Medical
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIb
93/42
Website
marketing@pro-hifu.com
EUDAMED record
Report an error
Shenzhen Pump Medical System FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR, 93/42
marketing@bpump.com.cn
EUDAMED record
Report an error
Shenzhen Roundwhale Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Combo Electrotherapy Device R-C1(MEX1/RW1/SA3), R-C3, R-C101A~L/W, R-C4A(AUS1/RW1~RW3/U12), R-C4B(AUS12/DE4/RW1), R-C4C(AUS1), R-C4D(RW1/U7/U9/WH1), R-E1, R-T1, F100, M100A(WH1), M101A(UK1/WH2), M102A, M103A, M104A, MINI-TENS-COMB, TENS3500 3 refs Combo Electrotherapy Device R-W100/R-W101/R-W200/R-W201 ( A~E each); R-I100/R-I200/R-I300/R-I400/R-I500/R-I600 (A~E each); R-H100A~E; R-C102/R-C103/R-C104/R-C105/R-C106/R-C108/R-C109/R-C110/R-C111/R-C112 (A~E each); R-C101S 3 refs Magnetic therapy device R-M100 3 refs
IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen Vivolight Medical Device & Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR, 93/42
EUDAMED record
Report an error
Shinhung FDA
EU representative : AR Experts B.V. (Netherlands)
South Korea
IIa
93/42
EUDAMED record
Report an error
SHL Telemedicine International FDA
EU representative : SHL Telemedizin GmbH (Germany)
Israel
IIa
93/42
Website
info@shl-telemedicine.com
EUDAMED record
Report an error
Sidam FDA
Italy
IIa
MDR
info@sidamit.it
EUDAMED record
Report an error
Simzo FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR, 93/42
info@simzo.net
EUDAMED record
Report an error
Sisensing
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
Website
support@sibionics.com
EUDAMED record
Report an error
Sistemi Iperbarici
Italy
IIb
93/42
EUDAMED record
Report an error
Soltec
Italy
I, IIb
MDR
Website
info@soltec.it
EUDAMED record
Report an error
Solutions
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Somatics FDA
EU representative : FBI Medizintechnik GmbH (Germany)
United States
I, IIb
MDR, 93/42
Website
sales@thymatron.com
EUDAMED record
Report an error
Spencer FDA
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Stowood
EU representative : Medaptivo EU Ltd. (Ireland)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
sales@stowood.co.uk
EUDAMED record
Report an error
Suzhou AcuVu Medical Technology FDA
EU representative : Eunitor GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Suzhou Medical Appliance Factory FDA
EU representative : Metrax GmbH (Germany)
China
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Suzhou Minhua Medical Equipment FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
Disposable Deep Vein Thrombosis Cuff V608-SC01, V608-SC02, V608-SC03, V608-SC04, V608-ST01, V608-ST02, V608-ST03, V608-ST04, V608-SF01, V608-SF02 V608-SC01R, V608-SC02R, V608-SC03R, V608-SC04R, V608-ST01R, V608-ST02R, V608-ST03R, V608-ST04R, V608-SF01R, V608-SF02R
I
MDR
EUDAMED record
Report an error
Swlmed
Germany
III
MDR
Website
EUDAMED record
Report an error
SycoTec FDA
Germany
I
93/42
Website
info@sycotec.eu
EUDAMED record
Report an error
T.A.G. Medical products FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Israel
IIa
MDR
Website
info@tag-med.com
EUDAMED record
Report an error
Taiyuan North China Xinyuan Tech Center FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Tende
Türkiye
IIb
93/42
Website
info@tende.com.tr
EUDAMED record
Report an error
Terma
Poland
I
MDR
Website
EUDAMED record
Report an error
Terumo BCT FDA
EU representative : Terumo BCT Europe N.V. (Belgium)
United States
I, IIa
MDR
Website
eudamed@terumobct.com
EUDAMED record
Report an error
Tonglu Sike Medical Instrument
EU representative : endodoctor GmbH (Germany)
China
BJ1001，BJ1002，BJ1003，BJ1004，BJ1008，BJ1009，BJ1010，BJ1011，BJ1012，BJ1013，BJ1014，BJ1015，BJ1016HD，BJ1017HD，BJ1018HD，BJ1019HD，BJ1032HD，BJ1033HD，BJ1034HD，BJ1035HD，BJ1040HD，BJ1041HD，BJ1042HD，BJ1043HD 3 refs EJ2001, EJ2001A, EJ2002, EJ2003, EJ2003A, EJ2004, EJ2005, EJ2006, EJ2007, EJ2008, EJ2009, EJ2010, EJ2011, EJ2012, EJ2013, EJ2014, EJ2015, EJ2016, EJ2017, EJ2018, EJ2019, EJ2020, EJ2021, EJ2022, EJ2023, EJ2024, EJ2025, EJ2026 3 refs HJ3001、HJ3002、HJ3003、HJ3004、HJ3005、HJ3006、HJ3007、HJ3008、HJ3009、HJ3010、HJ3011、HJ3012、HJ3013、HJ3014、HJ3015、HJ3016 3 refs
I
MDR
EUDAMED record
Report an error
TOP FDA
EU representative : MPS Medical Product Service GmbH (Germany)
Japan
IIb
93/42
Website
EUDAMED record
Report an error
Toyedent
EU representative : SUNGO Europe B.V. (Netherlands)
China
TY-302,TY-306,TY-307,TY-309,TY-310,TY-311,TY-312,TY-314,TY320,TY330,TY340,TY350,TY360,TY370,TY380,TY390 TY-E1,TY-E2,TY-806,TY-808, TY-809, TY-830, TY-860, TY-815 TY-E8,TY-E9,TY-5,TY-10,TY-11,TY-20,TY-30,TY-40
I
MDR
EUDAMED record
Report an error
Transmed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
sales@transmed.com.cn
EUDAMED record
Report an error
Transonic FDA
EU representative : Transonic Europe BV (Netherlands)
United States
IIa
MDR
Website
regulatory@transonic.com
EUDAMED record
Report an error
Treatlite
Sweden
IIa
93/42
Website
info@treatlite.se
EUDAMED record
Report an error
Tribo
Poland
I
MDR, 93/42
Website
EUDAMED record
Report an error
Tulipmedical FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Ultraviol
Poland
IIa
93/42
Website
EUDAMED record
Report an error
Utech
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Uvsmart FDA
Netherlands
IIa
MDR
Website
info@uvsmart.nl
EUDAMED record
Report an error
Vennermedical FDA
Germany
IIb
93/42
Website
info@vennermedical.de
EUDAMED record
Report an error
Versandafne
Italy
IIa
MDR
EUDAMED record
Report an error
Vistar Medical Supplies FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Vitberg
Poland
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Vitrolife FDA
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Vivest
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb, III
MDR, 93/42
EUDAMED record
Report an error
Weony (Shenzhen) Technology
EU representative : Prolinx GmbH (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
WHTcare
EU representative : WINTECARE ESPAÑA, S.L. (Spain)
Switzerland
IIa, IIb
MDR, 93/42
info@whtcare.ch
EUDAMED record
Report an error
X-Nav Technologies FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR, 93/42
Website
regulatory@x-navtech.com
EUDAMED record
Report an error
Xianju Zhengjie Medical Instrument
EU representative : REP Europe GmbH (Germany)
China
MEDICAL PENDANT DYT-SB, DYT-DB, DYT-MZ, DYT-SQJ, DYT-DQJ, DYT-YY, DYT-ICU, JYT-MZ, JYT-SB, JYT-DB, JYT-SQJ, JYT-DQJ,JYT-YY, JYT-ICU OPERATING LIGHT OPERATING TABLE DT-12E, DT-12D, DT-12G, DT-2A, DT-12C, DT-12F, DT-YK, JYK, JT-2A, 3008, 3008A, 3008B, 3008D, 3001-1, 300, 3001A, 3001B, PT, ZJ-A, ZJ-B, ZJ-C, ZJ-D；DS-8, DS-3004, 3004, FS, FS-A, FS-B, ZJ-E, ZJ-F, ZJ-G
I
MDR
admin@cnxjyc.com
EUDAMED record
Report an error
Yuratek
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Zeisberg
Germany
I
MDR
Website
EUDAMED record
Report an error
Zhejiang POCTech
EU representative : Prolinx GmbH (Germany)
China
IIb
MDR
service@poctechcorp.com
EUDAMED record
Report an error
Zhengzhou Olive Electronic Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Zhuhai Dipu Medical Technology FDA
EU representative : PureCE B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Zhuolu Jontelaser Manufacturing Technology FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Zoncare FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
China
ZONCARE iMAC 12,iMAC 12pro,iMAC 120,iMAC 120pro,iMAC 300,iMAC 300pro，E120,E120s,E120pro,E12,E12s,E12pro,E30,E30s,E30pro ZONCARE iMAC 1800, iMAC 1800pro ZONCARE iMAC 300, iMAC 300pro, MAC 120, iMAC 120pro,iMAC 12, iMAC 12pro 93/42
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Fimet
Finland
1 other
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Bmt
Czechia
I, IIa
MDR, 93/42
Website
regulatory@bmt.cz
EUDAMED record
Report an error
Henan Tuoren Kingtaek Medical Device
EU representative : MedNet EC-REP GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Navbit FDA
EU representative : Emergo Europe B.V. (Netherlands)
Australia
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Hpotech
Türkiye
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Intersurgical FDA
EU representative : UAB Intersurgical (Lithuania)
Italy, United Kingdom (ex Northern Ireland)
I, IIb
MDR
Website
EUDAMED record
Report an error
Kowa FDA
EU representative : Kowa Europe GmbH (Germany) and 1 other
Japan
I
MDR, 93/42
EUDAMED record
Report an error
Lojer FDA
Finland
I
MDR
Website
info@lojer.com
EUDAMED record
Report an error
Meridian Medical FDA
Finland
IIb
93/42
info@valon.fi
EUDAMED record
Report an error
Sooma
Finland
I, IIa
MDR, 93/42
Website
regulatory@soomamedical.com
EUDAMED record
Report an error
VitreQ FDA
Netherlands
IIa, IIb
MDR
infovitreq@bvimedical.com
EUDAMED record
Report an error
2El
Czechia
IIa
93/42
EUDAMED record
Report an error
Aacurat
Germany
I
MDR
Website
info@aacurat.de
EUDAMED record
Report an error
ab medica
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Abcmed
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Ackermann Instrumente FDA
Germany
I
MDR
Website
info@ackermannsurgical.com
EUDAMED record
Report an error
Acurio
EU representative : MedNet EC-REP GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Adroit Surgical FDA
EU representative : Obelis s.a. (Belgium)
United States
I
MDR
Website
info@adroitsurgical.com
EUDAMED record
Report an error
Advanced Sterilization Products FDA
EU representative : ASP, The Netherlands B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Aedmax
Poland
III
MDR
Website
EUDAMED record
Report an error
Aerolase FDA
EU representative : MDSS GmbH (Germany)
United States
IIb
93/42
Website
information@aerolase.com
EUDAMED record
Report an error
Aid United(Jiangsu)Sports Goods
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Airex
EU representative : 3A Composites GmbH (Germany)
Switzerland
I
MDR
Website
info@my-airex.com
EUDAMED record
Report an error
Albertnovosino FDA
EU representative : Sungo Cert GmbH (Germany)
China
5cm, 5.5cm, 6cm, 6.5cm, 7cm, 7.5cm, 8cm, 8.5cm, 9cm, 10cm OS801, OS802, OS803, OS804, OS805, OS806, OS807, OS808, OS809, OS810, OS811, OS812, OS813, OS814, OS816, OS817, OS818, OS819, OS820, OS821, OS826, OS828, OS830
I
MDR
EUDAMED record
Report an error
Allengersglobal FDA
EU representative : Easy Medical Device CommV (Belgium)
India
IIb
MDR, 93/42
Website
ra.global@allengers.net
EUDAMED record
Report an error
Allwinmedical FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United States
I, IIa
MDR
Website
info@allwinmedical.com
EUDAMED record
Report an error
Alma Lasers FDA
Germany
IIb
MDR
Website
info@alma-lasers.de
EUDAMED record
Report an error
Altomed FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
93/42
EUDAMED record
Report an error
Amplifon FDA
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Ams Ood
Bulgaria
I
MDR
Website
info@amsmed.eu
EUDAMED record
Report an error
Anhui Happiness Workshop Medical Instruments FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Anhui YODO Biotechnology
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
China
I, IIa
MDR
EUDAMED record
Report an error
Appliedmedical FDA
EU representative : Applied Medical Europe B.V. (Netherlands)
United States
I, IIb
MDR
RAQS-Management@appliedmedical.com
EUDAMED record
Report an error
Apyx Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
93/42
Website
EUDAMED record
Report an error
Aretechllc FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
I
MDR
Website
info@aretechllc.com
EUDAMED record
Report an error
Ari Medical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
AML700D/700D,AML700D/500D,AML500D/500D AML700D,AML700DL,AML500D,AML500DL AML700/700,AML700/500,AML500/500,AML700, AML500,AML700S,AML700E,AML500S,AML500E, AML-LED.STZ5, etc AMT-D.III, AMT-D.III-I, AMT-D.III-II, AMT-D.III-III, AMT-D.IA, AMT-D.IA-II, EOT-99, EOT-99C, EOT-99D, EOT-99S, EOT-2000, DL.A, DL.B, DL.B (New), DL.C, ET99, ET200, AMT-CB.I, AMT-CB.II, GOT-99A, GOT-99B, GOT-99D, GOT-06A, GOT-06B, AMT-FS.I, etc
I
MDR
info@ari-cn.com
EUDAMED record
Report an error
Armedical
Poland
I
MDR
Website
EUDAMED record
Report an error
Artrotec
Spain
I
MDR
Website
info@wad-drguillen.com
EUDAMED record
Report an error
Asieris
EU representative : MedNet EC-REP GmbH (Germany)
China
I, IIa
MDR
Website
EUDAMED record
Report an error
Aspel
Poland
IIa
MDR
Website
eudamed@aspel.com.pl
EUDAMED record
Report an error
Aspensurgical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I, IIa, IIb
MDR
Website
customerservice@aspensurgical.com
EUDAMED record
Report an error
Astekmed
Türkiye
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Atena Lux
Italy
I, IIa
MDR
Website
info@atenalux.com
EUDAMED record
Report an error
Atesos
EU representative : hestomed GmbH (Germany)
Switzerland
I
93/42
Website
info@atesos.ch
EUDAMED record
Report an error
Auditdata FDA
Denmark
IIa
MDR
Website
compliance@auditdata.com
EUDAMED record
Report an error
Aveflor FDA
Czechia
I
MDR
Website
EUDAMED record
Report an error
B L Lifesciences
EU representative : Obelis s.a. (Belgium)
India
ipeX Plain, Red, Blue, Yellow 93/42 Ipex,ABMG,ACTIMED,Quality Medical, Sky Medical, CMI Single, Double, Triple with/without sampling Device/sampling stopcock 93/42
IIa, IIb
93/42
Website
regulatory@bllifesciences.com
EUDAMED record
Report an error
B. & B. Dental
Italy
IIa
MDR
Website
info@bebdental.it
EUDAMED record
Report an error
Bamateknoloji
Türkiye
IIa
MDR
Website
EUDAMED record
Report an error
Barkey FDA
Germany
IIa
MDR
Website
info@barkey.de
EUDAMED record
Report an error
be-on-market
Germany
I
MDR
info@be-on-market.com
EUDAMED record
Report an error
Beacmed
Italy
IIa
MDR
Website
info@beacmed.eu
EUDAMED record
Report an error
Beaconn
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
info@beaconn.cn
EUDAMED record
Report an error
BEE Medic FDA
Germany
I
MDR
Website
prrc@beemedic.de
EUDAMED record
Report an error
Beijing Fanxing Guangdian Medical Treatment Equipment FDA
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Beijing HuaCheng Taike Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIa
93/42
info@cosmedplus.com
EUDAMED record
Report an error
Beijing Jingdong Technology (Laoting)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
JDC-PC, JDC-DY,JDC-SY,JDC-SO,JDC-ET,JDCZC,JDCJJ,JDCQY, JDCSG,JDCWG,JDCJF,JDCYR,JDC-DJ,JDC-ZY,JDCMY-SY, JDCMY-SO,JDC-JC JDCJH
I
MDR
service@bjjingdong.com
EUDAMED record
Report an error
Beijing Rongrui-Century Science & Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
Beneeon (Jiangsu) Medical Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
sales@bnycmed.com
EUDAMED record
Report an error
Benergygroup
Italy
I
MDR
Website
EUDAMED record
Report an error
Bestdent Foshan Medical Equipment
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
info@bestdentmed.com
EUDAMED record
Report an error
Better medical technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
BT310A ,BT681E-500,BT681E-500/700 Instrument Cabinet BT154,BT155,BT156,BT157,BT159,BT159C,BC154,BC155,BC156,BC158,
I
MDR
Website
sale1@better-med.com
EUDAMED record
Report an error
Beyazgrup
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Bfp
France
IIa
93/42
Website
contact@bfp.group
EUDAMED record
Report an error
Biodenta FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Switzerland
IIa
93/42
info@biodenta.com
EUDAMED record
Report an error
Biodex Medical Systems
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Bioland FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Bionime FDA
EU representative : Emergo Europe B.V. (Netherlands)
Taiwan
IIb
MDR
EUDAMED record
Report an error
BIOS FDA
Italy
IIa, IIb
MDR, 93/42
Website
quality@biosgroup.eu
EUDAMED record
Report an error
Biosurgical
Spain
IIb
93/42
EUDAMED record
Report an error
Biotronik FDA
Germany
IIb
MDR
Website
info@biotronik.com
EUDAMED record
Report an error
Bissinger FDA
Germany
IIb
93/42
Website
info@bissinger.com
EUDAMED record
Report an error
Bo&Bo FDA
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
Website
EUDAMED record
Report an error
BojongMC FDA
EU representative : Obelis s.a. (Belgium)
South Korea
Physiotherapy Apparatus SE-1000 93/42 Physiotherapy Apparatus SP-1100, SP-2100, SP-3100,SP-RB1000, SP-1100E, SP-2100E, SP-3100E, SP-1100WR, SP-1100S, SP-2100S, SP-3100S, SP-1100PS, SP-2100PS, SP-1100P, SP-1100PE, SP-2100P, SP-2100PE 93/42
I, IIa
93/42
Website
inform@bojongmc.co.kr
EUDAMED record
Report an error
Bokang FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
ALPHAMED BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007 3 refs Electronic sphygmomanometer BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032 2 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
Braebon FDA
EU representative : AR Experts B.V. (Netherlands) and 1 other
Canada
IIa
MDR, 93/42
Website
info@braebon.com
EUDAMED record
Report an error
Brainnavi FDA
EU representative : MDSS GmbH (Germany)
Taiwan
I, IIb
93/42
Website
service@brainnavi.com
EUDAMED record
Report an error
Bredent FDA
Germany
IIb
MDR
Website
info-medical@bredent.com
EUDAMED record
Report an error
Brumaba FDA
Germany
I
MDR
Website
info@brumaba.de
EUDAMED record
Report an error
Bssmedikal
Türkiye
IIb
93/42
Website
info@bssmedikal.com
EUDAMED record
Report an error
BTE Technologies FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
regulatory@btetechnologies.com
EUDAMED record
Report an error
Burl Concepts
EU representative : ICON (LR) Limited (Ireland)
United States
I, IIa
MDR
Website
EUDAMED record
Report an error
Byteflies FDA
Belgium
I
MDR
Website
hello@byteflies.com
EUDAMED record
Report an error
Calyx Medical
Poland
I
MDR
Website
EUDAMED record
Report an error
Canfieldsci FDA
EU representative : CANFIELD SCIENTIFIC SRL (Italy)
United States
I
MDR
EUDAMED record
Report an error
Canta FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Cardia FDA
Sweden
IIa
93/42
quality@cardia.se
EUDAMED record
Report an error
Caremedical FDA
EU representative : Everbiz GmbH (Germany)
China
IIb
MDR, 93/42
EUDAMED record
Report an error
Carestream Dental FDA
EU representative : TROPHY (France)
United States
I
MDR
EUDAMED record
Report an error
Carmex FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
IIa
MDR
info@carmex.com
EUDAMED record
Report an error
Cerenovus FDA
EU representative : DePuy Ireland UC (Ireland)
United States
I, IIa
MDR
Website
EUDAMED_Enquiries@its.jnj.com
EUDAMED record
Report an error
Channel Medsystems FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
I, IIb
MDR
Website
info@cerene.com
EUDAMED record
Report an error
Chaoyangmedical
EU representative : SUNGO Europe B.V. (Netherlands)
China
CY-C99B, CY-C99A, CY-C5, CY-C6, CY-C7, CY-C8,CY-C06C, CY-OT99A, CY-OT2000, CY-OT2000E, CY-OT99, CY-OT3001E, CY-OT2001, CY-OT300, CY-OT600, CY-OT600A,CY5, CY6, CY-C370, CY-C371,CY-C326 CY-DT930, DIGIT-TRAC 930, CY-T1, CY-T2, CY-T3, CY-T4
I
MDR
sales01@chaoyangmedical.cn
EUDAMED record
Report an error
Chapletint
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Charder FDA
EU representative : Obelis s.a. (Belgium)
Taiwan
I, IIa
MDR
Website
EUDAMED record
Report an error
Checkpoint Surgical FDA
EU representative : WMDE B.V. (Netherlands)
United States
IIa
93/42
Website
Regulatory@checkpointsurgical.com
EUDAMED record
Report an error
Chengdu Mediate Technology
EU representative : Humiss Beratung GmbH (Germany) and 1 other
China
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Chin Kou Medical Instrument FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Taiwan
I
MDR
Website
info@spiritmedical.com.tw
EUDAMED record
Report an error
Chirana Progress, s.r.o
Slovakia
I, IIa
MDR
Website
EUDAMED record
Report an error
Chirmed
Poland
I
MDR
Website
info@chirmed.pl
EUDAMED record
Report an error
Chm
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Chungwoo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIb
MDR, 93/42
EUDAMED record
Report an error
Cinarmedikal
Türkiye
I
MDR
Website
info@cinarmedikal.com
EUDAMED record
Report an error
CMR Surgical FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I, IIa
MDR
Website
EUDAMED record
Report an error
Cnsystems FDA
Austria
IIa, IIb
MDR, 93/42
Website
office@cnsystems.com
EUDAMED record
Report an error
Codan Argus
EU representative : CODAN pvb Critical Care GmbH (Germany)
Switzerland
IIb
MDR
Website
regulatory@codanargus.com
EUDAMED record
Report an error
Comepa FDA
France
I
MDR
info@comepa.com
EUDAMED record
Report an error
Comercial Cosmetica Valladolid
Spain
IIa
MDR
Website
EUDAMED record
Report an error
Cosmo Robotics FDA
EU representative : ExoAtlet Global S.A. (Luxembourg)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
Crosstex FDA
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Crystalvue FDA
EU representative : MDSS GmbH (Germany)
Taiwan
IIa
MDR
Website
RA.CV@Crystalvue.com.tw
EUDAMED record
Report an error
Cura Farma
Italy
I
MDR
Website
EUDAMED record
Report an error
D-SAM International
EU representative : CS Active (Latvia)
Pakistan
I
MDR
Website
info@dsamintel.com
EUDAMED record
Report an error
Dalian Labtek Science & Development FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Danyang New Hope Medical Equipment FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
Sales@dynewhope.com.cn
EUDAMED record
Report an error
Datascope FDA
EU representative : MAQUET Critical Care AB (Sweden)
United States
IIb
93/42
Website
EUDAMED record
Report an error
DecoCare
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Denjoy Dental FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
I
MDR
EUDAMED record
Report an error
DermLite FDA
EU representative : E C REP LIMITED (Ireland)
United States
I
MDR
Website
EUDAMED record
Report an error
Destlo
Poland
I
MDR
Website
EUDAMED record
Report an error
DGH Technology FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
info@dghtechnology.com
EUDAMED record
Report an error
Diagnosis
Poland
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
DIPLOMAT DENTAL s.r.o
Slovakia
I, IIa
MDR
Website
info@diplomat-dental.com
EUDAMED record
Report an error
Dirostech FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
IIb
MDR
Website
info@dirostech.com
EUDAMED record
Report an error
Diversatek Healthcare FDA
EU representative : Advena Limited (Malta)
United States
I, IIa
MDR
Website
sales@diversatekhc.com
EUDAMED record
Report an error
Dovideqmedical
Netherlands
I
MDR
Website
info@dovideqmedical.com
EUDAMED record
Report an error
Duerrdental FDA
Germany
IIa
MDR
Website
regulatory@duerrdental.com
EUDAMED record
Report an error
Dzmedicalesrl
Italy
IIa, IIb
MDR, 93/42
Website
info@dzmedicalesrl.com
EUDAMED record
Report an error
Dörr Kampen
Netherlands
I
MDR
Website
info@dorrkampen.nl
EUDAMED record
Report an error
Dürr Technik
Germany
I
MDR
Website
EUDAMED record
Report an error
EB Neuro FDA
Italy
IIb
MDR
Website
info@ebneuro.com
EUDAMED record
Report an error
Edenta FDA
Liechtenstein
IIa
MDR
Website
EUDAMED record
Report an error
El.En FDA
Italy
IIa, IIb
MDR
Website
info@elen.it
EUDAMED record
Report an error
Electrodynamics Manufacturing
Greece
IIa
93/42
EUDAMED record
Report an error
eLEDricity FDA
Belgium
IIa
MDR
Website
qara@zaparay.com
EUDAMED record
Report an error
ElitechGroup FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
I, IIa
MDR
Website
info@elitechgroup.com
EUDAMED record
Report an error
Elltec
EU representative : Obelis s.a. (Belgium)
Japan
IIb
93/42
Website
EUDAMED record
Report an error
Eltek Instruments FDA
EU representative : CS Active (Latvia)
Pakistan
I
MDR
info@eltekinstruments.com
EUDAMED record
Report an error
em-tec
Germany
I
MDR
Website
EUDAMED record
Report an error
Envisen FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Esumedics
Germany
IIb
MDR
Website
info@esumedics.com
EUDAMED record
Report an error
Ethicon Endo-Surgery FDA
EU representative : Johnson & Johnson Medical GmbH (Germany)
United States
IIb
MDR
eudamed_enquiries@its.jnj.com
EUDAMED record
Report an error
eXroid Technology
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
raqamanager@exroid.com
EUDAMED record
Report an error
Fabrication Enterprises
EU representative : AJW Technology Consulting GmbH (Germany)
United States
I
MDR
Website
EUDAMED record
Report an error
Farapulse FDA
EU representative : ICON (LR) Limited (Ireland)
United States
IIb
93/42
Website
EUDAMED record
Report an error
Faro FDA
Italy
I
MDR
Website
info@faro.it
EUDAMED record
Report an error
FENTEX medical FDA
Germany
I
MDR
Website
info@fentexmedical.com
EUDAMED record
Report an error
FHC FDA
EU representative : TERMOBIT PROD SRL (Romania)
United States
I, IIa
MDR
Website
EUDAMED record
Report an error
Fiagon FDA
Germany
IIa
MDR
Website
info@fiagon.com
EUDAMED record
Report an error
FIMS FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIa
93/42
EUDAMED record
Report an error
Finapres FDA
Netherlands
IIa
MDR, 93/42
Website
info@finapres.com
EUDAMED record
Report an error
Finicare FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
Dr. Max Upper Arm Electronic Blood Pressure Monitor FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112, FC-BP103, FC-BP113, FC-BP120, FC-BP130, FC-BP131 3 refs Wrist Electronic Blood Pressure Monitor FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221 3 refs
IIa
MDR
EUDAMED record
Report an error
Fischer ANalysen Instrumente FDA
Germany
I, A
IVDR, MDR
Website
EUDAMED record
Report an error
Fisiostore
Italy
I
MDR
info@fisiostore.it
EUDAMED record
Report an error
Flight Medical Innovations FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIb
93/42
Website
EUDAMED record
Report an error
Folee
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Foracare FDA
EU representative : MedNet EC-REP GmbH (Germany)
Switzerland
IIa
93/42
Website
EUDAMED record
Report an error
Foshan Roson Medical Instruments
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
93/42
EUDAMED record
Report an error
Fotofinder FDA
Germany
I
MDR
info@fotofinder.de
EUDAMED record
Report an error
France Développement Electronique
France
IIb
MDR
Website
qualite@fde.fr
EUDAMED record
Report an error
FreMon Scientific FDA
EU representative : G&D&Y (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Fresenius Kabi FDA
Germany
IIb
MDR
Website
EUDAMED-FK@fresenius-kabi.com
EUDAMED record
Report an error
Frida FDA
EU representative : Nasalprodukter Sverige AB (Sweden)
United States
I
MDR
Website
EUDAMED record
Report an error
Fusmobile FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
Israel
I, IIb
MDR
rani1@fusmobile.com
EUDAMED record
Report an error
GaleMed FDA
EU representative : Emergo Europe B.V. (Netherlands)
China, Taiwan
I
MDR
Website
EUDAMED record
Report an error
GE Medical Systems FDA
EU representative : GE Medical Systems SCS (France)
China
IIb
MDR
eudamed@gehealthcare.com
EUDAMED record
Report an error
Geister FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Gerium Medical FDA
EU representative : AR Experts B.V. (Netherlands)
Israel
I, IIa
MDR
EUDAMED record
Report an error
Glamox
Norway
I
MDR
Website
info@glamox.com
EUDAMED record
Report an error
Golden Star FDA
Italy
IIb
MDR
Website
EUDAMED record
Report an error
Goodmedica
Poland
IIa
MDR
Website
office@goodmedica.pl
EUDAMED record
Report an error
Guangdong Richjinn Medical Technology
EU representative : Humiss Beratung GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Guangdong Xinyu Electronic Technology FDA
EU representative : Share info GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Guangzhou Fourier Intelligence
EU representative : MedNet EC-REP GmbH (Germany)
China
IIa
MDR
info@fftai.com
EUDAMED record
Report an error
Gustav Baehr
Germany
IIa
MDR
Website
eudamed@gustav-baehr.de
EUDAMED record
Report an error
Gvs FDA
EU representative : GVS S.p.A. (Italy)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Gymna
Belgium
IIa
MDR
Website
info@gymna-uniphy.com
EUDAMED record
Report an error
Hangzhou AGS MedTech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Hangzhou Xiangrui Medical Equipment
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Hanshinmed
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
Harbin Howell Medical Apparatus Instruments FDA
EU representative : Caretechion GmbH (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
Hartmann FDA
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
Hcitaliasrl
Italy
IIa
93/42
Website
info@hcitaliasrl.com
EUDAMED record
Report an error
Hcmmed
EU representative : SUNGO Europe B.V. (Netherlands)
China
HCM 8260, HCM 8261, HCM 8262, HCM 8263, HCM 8264, HCM 8265, HCM 8266, HCM 8267, HCM 8268, HCM 8269, HCM8270, HCM8271, HCM8272, HCM8273, HCM8274, HCM8275, HCM8276, HCM8277, HCM8278, HCM8279 3 refs HCM 9693, HCM 9694,HCM 9695, HCM 9696, HCM 9697,HCM 9698, HCM 9699, HCM 9688, HCM 9888, HCM 9889, HCM 9912,HCM9913, HCM9914, HCM9915, HCM9916, HCM9917, HCM9918,HCM 9919, HCM9920, HCM9921 3 refs
I
MDR
EUDAMED record
Report an error
Hebei Boxin Recovery Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
info@boxinhomecare.com
EUDAMED record
Report an error
Helix Surgical
France
I, IIb
MDR
Website
contact@helixsurgical.com
EUDAMED record
Report an error
Henan Olive Electronic Technology
EU representative : MedPath GmbH (Germany)
China
IIa, IIb
MDR
EUDAMED record
Report an error
Hepho
EU representative : R Sight B.V. (Netherlands)
China
IIb
93/42
EUDAMED record
Report an error
HERCO Wassertechnik
Germany
IIb
MDR
info@hercowater.com
EUDAMED record
Report an error
HeVaTech
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
Hilbro FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
EUDAMED record
Report an error
Hiprove
EU representative : Caretechion GmbH (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
Hirayermed
EU representative : Humiss Beratung GmbH (Germany)
China
I
MDR
Website
info@hirayermed.com
EUDAMED record
Report an error
Hi̇pertek Elektroni̇k Ve Maki̇na San Ti̇c Şti̇
Türkiye
IIb
93/42
Website
information@hipertech.com.tr
EUDAMED record
Report an error
Horigen FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Hospital & Homecare Medical Device China
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
sales6@aline-medical.com
EUDAMED record
Report an error
HSD
EU representative : Quaser S.r.l. (Italy)
San Marino
IIa
MDR
info@hsd.sm
EUDAMED record
Report an error
Hubei Yinkang Medical Equipment FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
YKD001, YKD002, YKD003, YKD004, YKD005, YKD005A, YKD005B, YKD008, YKD009, YKD010 YKD006, YKD007, YKD007A, YKD007B, YKD011
I
MDR
EUDAMED record
Report an error
Hubei Yuda Medical Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
DST-200A,DST-300A,DST-300C,DST-300D,DST-400A,DST-500A,DST-700A,DST-700G,DST-700Q,DST-800A,JR-9000,DST-800C ,D-0015 YDZ700/500,YDZ700/700,YDZ500/500,YDZ700, YDZ500,YDZ500D,YDE700/500,YDE700/700, YDE500/500,YDE700,YDE500,YDE700/500FS,etc
I
MDR
EUDAMED record
Report an error
Hulaser FDA
EU representative : OMC NI MEDICAL LIMITED (Northern Ireland)
South Korea
IIb
93/42
Website
info@hulaser.com
EUDAMED record
Report an error
Humedics
Germany
IIb
MDR, 93/42
Website
info@humedics.de
EUDAMED record
Report an error
Hunan Endovascular Device
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR
Sales@hnevd.com
EUDAMED record
Report an error
i-SENS FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
IIb
MDR
Website
regulatory@i-sens.com
EUDAMED record
Report an error
I.A.C.E.R
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Icaros
Germany
I
MDR
Website
info@icaros.com
EUDAMED record
Report an error
Idrogenet FDA
Italy
IIa
93/42
EUDAMED record
Report an error
Igel
Poland
IIb
93/42
Website
EUDAMED record
Report an error
Illuco FDA
EU representative : AeMi World e.K (Germany)
South Korea
I
MDR
Website
info@illuco.co.kr
EUDAMED record
Report an error
Imed
Hungary
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
ImpediMed FDA
EU representative : MDSS GmbH (Germany)
Australia
IIa
93/42
Website
EUDAMED record
Report an error
iMS FDA
Germany
IIb
MDR, 93/42
Website
info@ims-medical.de
EUDAMED record
Report an error
Incidental
Türkiye
I
MDR
Website
info@incidental.com.tr
EUDAMED record
Report an error
Infivision
EU representative : HUMISS TRADING S. L. (Spain) and 1 other
China
IIa
MDR
Website
EUDAMED record
Report an error
Iridex FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Iseemed
EU representative : MedPath GmbH (Germany)
China
I, IIa
MDR
info@iseemed.com
EUDAMED record
Report an error
Isko
Türkiye
I, IIa
MDR
EUDAMED record
Report an error
Iskramedical FDA
Slovenia
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
iSYS Medizintechnik FDA
Austria
I
MDR
Website
info@interventional-systems.com
EUDAMED record
Report an error
Jablotron
Czechia
IIb
93/42
EUDAMED record
Report an error
Japet
France
IIa
93/42
Website
contact@japet.eu
EUDAMED record
Report an error
JFA Medical
EU representative : CMC Medical Devices & Drugs SL (Spain)
United Kingdom (ex Northern Ireland)
I
MDR
Website
admin01@jfamedical.co.uk
EUDAMED record
Report an error
Jiangsu Joncn Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
EOT200001, EOT200002, EOT200005, EOT200003, EOT200006, EOT200007, EOT200008, EOT200010, EOT200011, EOT200012, EOT200013, EOT200015, EOT200016, EOT200017, EOT200018, EOT200020, EGT180001, EGT180005, EGT180002, EGT150003, EGT120006, EGT180003, etc 3 refs OT200001, OT200005, OT200002, OT200003, OT200006, OT200007, OT200008, OT200011, OT200012, OT200013, OT200015, OT200016, OT200017, GT180001, GT180002, GT180003, GT180005, GT180006, GT180007, GT180008, GT180010, GT180011, XD185001, XD185002, XD185007, etc 3 refs
I
MDR
EUDAMED record
Report an error
Jiangsu Yongfa Medical Equipment Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
info@chinayongfa.com
EUDAMED record
Report an error
Jiangxi Dentalbright Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I, IIa
MDR
EUDAMED record
Report an error
Jm Tech FDA
EU representative : Meridius Medical Europe Limited (Ireland)
South Korea
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Kardinero
Türkiye
IIa
93/42
Website
info@kardinero.com.tr
EUDAMED record
Report an error
Ken FDA
Denmark
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Kenex FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Kfh
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Kimetec FDA
Germany
I, IIa
MDR, 93/42
Website
info@kimetec.de
EUDAMED record
Report an error
Kjmedi FDA
EU representative : S.B. Pharma GmbH (Germany)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
KMS Kirchensaller Maschinenbau Schaser
Germany
I
MDR
Website
info@spinefit.de
EUDAMED record
Report an error
Korust
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
La Tecnomedica
Italy
IIa
MDR
Website
info@latecnomedica.it
EUDAMED record
Report an error
Laserneedle
Germany
IIa
93/42
Website
info@laserneedle.eu
EUDAMED record
Report an error
LAUDA Medical
Germany
I, IIb
MDR
support@lauda-medical.com
EUDAMED record
Report an error
Lauschaer Glas
Germany
I
MDR
Website
contact@lauschaerglas.de
EUDAMED record
Report an error
LD Technology FDA
EU representative : Neomedica Iberia (Spain)
United States
IIa
MDR
Website
EUDAMED record
Report an error
LED Intellectual Properties FDA
EU representative : E C REP LIMITED (Ireland)
United States
IIa, IIb
MDR
Website
regulatory.team@lightstim.com
EUDAMED record
Report an error
Ledfix Elektronik Ticaret Anonim Sirketi
Türkiye
IIa
MDR
EUDAMED record
Report an error
Leng Medical Technology (Tianjin)
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
LHbiomed FDA
EU representative : TECHNOLUX Srl (Italy)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
LiDCO FDA
EU representative : LiDCO Netherlands B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIa
MDR
EUDAMED record
Report an error
LifeSignals FDA
EU representative : Renew Health Ltd. (Ireland)
United States
IIb
MDR
Website
EUDAMED record
Report an error
Lifeward FDA
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
Website
EUDAMED record
Report an error
Lifotronic FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Likamed FDA
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
Linamed FDA
EU representative : LiNA Medical Polska Sp. z o.o. (Poland)
Switzerland
IIb
MDR
Website
EUDAMED record
Report an error
Linova-X Tech
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Lomar
Italy
I, IIb
MDR
Website
EUDAMED record
Report an error
LumaDent FDA
EU representative : Brilitas Pharmaceuticals EU OÜ (Estonia)
United States
I
MDR
Website
EUDAMED record
Report an error
Lumie
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I, IIa
MDR
Website
info@lumie.com
EUDAMED record
Report an error
Luxomed
France
IIa
93/42
EUDAMED record
Report an error
Lynton
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIb
93/42
Website
info@lynton.co.uk
EUDAMED record
Report an error
Manatec FDA
France
IIa
93/42
Website
info@physioflow.com
EUDAMED record
Report an error
Mantis
Italy
IIa, IIb
93/42
EUDAMED record
Report an error
Maximus s.c. Robert Klejdysz, Alicja Daniecka-Klejdysz
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Mdd FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
customercare@mdd.org.uk
EUDAMED record
Report an error
Mdfinstruments FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
medaxis FDA
EU representative : Emergo Europe B.V. (Netherlands)
Switzerland
I
MDR
Website
info@medaxis.ch
EUDAMED record
Report an error
MedChip Solutions FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
EUDAMED record
Report an error
Medical Devices Group
Italy
I
MDR
EUDAMED record
Report an error
Medical Manufacturers Pty
EU representative : Advena Limited (Malta)
Australia
I
MDR
Website
quality@ingeneus.com.au
EUDAMED record
Report an error
Medical Quant
EU representative : Obelis s.a. (Belgium)
Israel
IIa
93/42
info@medical-quant.com
EUDAMED record
Report an error
Medisolaris
Türkiye
IIa
MDR
Website
info@medisolaris.com
EUDAMED record
Report an error
Medisteelpol
Poland
I
MDR
Website
EUDAMED record
Report an error
Meditech Systems FDA
EU representative : Clowrey Consultancy Limited (Ireland)
United Kingdom (ex Northern Ireland)
I, IIa
93/42
Website
admin@meditechsystems.co.uk
EUDAMED record
Report an error
MediTop FDA
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Medivance FDA
EU representative : Becton Dickinson Ireland Limited (Ireland)
United States
I, IIa, IIb
MDR, 93/42
eudamedenquiries@bd.com
EUDAMED record
Report an error
MEDlight
Germany
IIa
93/42
Website
info@medlight.eu
EUDAMED record
Report an error
Medmicro
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Medosel
Türkiye
IIa
93/42
Website
info@medosel.com
EUDAMED record
Report an error
Medplus
Poland
I
MDR
Website
EUDAMED record
Report an error
Medset
Germany
IIa
93/42
Website
EUDAMED record
Report an error
Medsphere
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Meridianmedical FDA
Slovenia
IIb
93/42
EUDAMED record
Report an error
Metrex Research
EU representative : KERR ITALIA SRL (Italy)
United States
I
MDR
Website
EUDAMED record
Report an error
Metsismedikal
Türkiye
III
93/42
Website
info@metsismedikal.com
EUDAMED record
Report an error
Microcopy, A Division of Neo-Flo
EU representative : Obelis s.a. (Belgium)
United States
IIa
MDR
EUDAMED record
Report an error
Minato Medical Science Kobe Facility
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Japan
IIa
MDR, 93/42
Website
qa-ra@minato-med.co.jp
EUDAMED record
Report an error
Mkb Medical System
Romania
I
MDR
office@mkb-system.ro
EUDAMED record
Report an error
Mnm Ingenieria Sca
Spain
I
93/42
EUDAMED record
Report an error
MolecuLight FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
IIa
MDR
Website
info@moleculight.com
EUDAMED record
Report an error
Monitortechnik FDA
Germany
IIb
MDR
info@monitortechnik.de
EUDAMED record
Report an error
Motiondental FDA
EU representative : Advena Limited (Malta)
Taiwan
I
MDR
Website
EUDAMED record
Report an error
MR
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
93/42
Website
info@mrev.co.kr
EUDAMED record
Report an error
Mt.Derm FDA
Germany
IIa
MDR
Website
info@mtderm.de
EUDAMED record
Report an error
Mts Medical Aktiengesellschaft
Germany
IIb
MDR
Website
eudamed@mts-medical.com
EUDAMED record
Report an error
MY01 FDA
EU representative : AR Experts B.V. (Netherlands)
Canada
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Myodev
France
I
MDR
Website
contact@myodev.com
EUDAMED record
Report an error
Namrol
Spain
I, IIb
MDR
Website
info@namrol.com
EUDAMED record
Report an error
Nanjing Chenwei medical equipment
EU representative : Kingsmead Service B.V. (Netherlands)
China
IIb
93/42
EUDAMED record
Report an error
Nanjing ShouLiang-med Technology
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Nanjing Yameng Intelligent Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
JCD-M01, JCD-M02, JCD-M03, JCD-M04, JCD-M05, JCD-M06, JCD-M07, JCD-M08, JCD-M09 TD-M01B-F, TD-M02B-F, TD-M03B-F, TD-M04B-F, TD-M05B-F, TD-M06B-F, TD-M07B-F, TD-M08B-F, TD-M09B-F, TD-N01, TD-N02, TD-N03, TD-N04, TD-N05, TD-N06, TD-N07, TD-N08, TD-N09, TD-HZ01, TD-HZ02, TD-HZ03, TD-HZ04, TD-HZ05, TD-HZ06, TD-HZ07, TD-HZ08, TD-HZ09 2 refs
I
MDR
EUDAMED record
Report an error
Nantong Healthcare Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
HCM 8260, HCM 8261, HCM 8262, HCM 8263, HCM 8264, HCM 8265, HCM 8266, HCM 8267, HCM 8268, HCM 8269, HCM8270, HCM8271, HCM8272, HCM8273, HCM8274, HCM8275, HCM8276, HCM8277, HCM8278, HCM8279 3 refs HCM 9693, HCM 9694,HCM 9695, HCM 9696, HCM 9697,HCM 9698, HCM 9699, HCM 9688, HCM 9888, HCM 9889, HCM 9912,HCM9913, HCM9914, HCM9915, HCM9916, HCM9917, HCM9918,HCM 9919, HCM9920, HCM9921 3 refs
I
MDR
EUDAMED record
Report an error
Nantong Medical Apparatus
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Neo G FDA
EU representative : European Healthcare & Device Solutions Ltd. (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@neo-g.co.uk
EUDAMED record
Report an error
Nestmedic
Poland
IIa
MDR
Website
office@nestmedic.com
EUDAMED record
Report an error
Neuron Guard FDA
Italy
IIa
MDR
Website
info@neuronguard.com
EUDAMED record
Report an error
New Age Italia
Italy
IIa
93/42
EUDAMED record
Report an error
Newclip Technics FDA
France
IIa
MDR
regulatory@newcliptechnics.com
EUDAMED record
Report an error
NICO FDA
EU representative : Atlantico Systems, Ltd. (Ireland)
United States
I, IIb
MDR
Website
info@NICOneuro.com
EUDAMED record
Report an error
Nidekmedical FDA
EU representative : mdi Europa GmbH (Germany)
United States
IIa, IIb
MDR, 93/42
Website
info@nidekmedical.com
EUDAMED record
Report an error
Nihon Kohden OrangeMed FDA
EU representative : NIHON KOHDEN EUROPE GmbH (Germany)
United States
IIb
MDR
Website
EUDAMED record
Report an error
Nikkiso FDA
EU representative : NIKKISO Medical Europe GmbH (Germany)
Japan
IIb
MDR, 93/42
EUDAMED record
Report an error
Ningbo Wise OptoMech Technology FDA
EU representative : Prolinx GmbH (Germany)
China
WiScope OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR, 3 refs WiScope OTU-A, OTU-T, 2 refs
I, IIa
MDR
sales@ws-medical.com
EUDAMED record
Report an error
Nipro FDA
EU representative : Nipro Medical Europe NV (Belgium)
Japan
IIb
93/42
EUDAMED record
Report an error
Nobamed
Germany
I
MDR
Website
info@nobamed-ag.com
EUDAMED record
Report an error
Nobamedi
EU representative : JaviTech e.K. (Germany)
South Korea
IIb
93/42
Website
contact@nobamedi.com
EUDAMED record
Report an error
North Eos Industries FDA
EU representative : Advena Limited (Malta)
Taiwan
I
MDR
EUDAMED record
Report an error
Novacor
France
I
MDR
Website
EUDAMED record
Report an error
novel FDA
Germany
I
MDR
Website
info@novel.de
EUDAMED record
Report an error
Novoxel FDA
EU representative : mdi Europa GmbH (Germany)
Israel
IIa
MDR
EUDAMED record
Report an error
Noxerior
Italy
IIb
93/42
info@noxerior.com
EUDAMED record
Report an error
Nsk
Germany
IIb
93/42
Website
EUDAMED record
Report an error
Ntl Healthcare FDA
EU representative : Advena Limited (Malta)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Nutricia Medical Devices
Netherlands
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Nysale
EU representative : Global E-commerce Experts Europe BV (Netherlands)
United States
IIa
MDR
EUDAMED record
Report an error
Omicron-Laserage Laserprodukte
Germany
IIb
93/42
Website
mail@omicron-laser.de
EUDAMED record
Report an error
Oms Officine Meccaniche Specializzate
Italy
I, IIa
MDR
EUDAMED record
Report an error
Oncudental
Türkiye
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Onyxcz
Czechia
IIb
93/42
Website
EUDAMED record
Report an error
Optergo
Sweden
I
MDR
Website
EUDAMED record
Report an error
Optovue FDA
EU representative : MDSS GmbH (Germany)
United States
IIa
MDR
Website
regulatory@optovue.com
EUDAMED record
Report an error
orangedental
Germany
I
MDR
Website
info@orangedental.de
EUDAMED record
Report an error
Origene
Netherlands
I
MDR
Website
info@origene.nl
EUDAMED record
Report an error
Orlvision FDA
Germany
I
MDR
Website
info@orlvision.de
EUDAMED record
Report an error
Osstem FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
MDR
EUDAMED record
Report an error
P&S Robotics FDA
EU representative : Arazy Group GmbH (Germany)
South Korea
IIa
MDR
Website
servicekr@walkbot.co.kr
EUDAMED record
Report an error
Parsianmedical
EU representative : Glomin GmbH (Germany)
Iran
IIb
MDR
Website
info@parsianmedical.com
EUDAMED record
Report an error
Parsys
France
IIa
MDR, 93/42
Website
info@parsys.com
EUDAMED record
Report an error
PENTAX of America FDA
EU representative : PENTAX Europe GmbH (Germany)
United States
I
MDR
EUDAMED record
Report an error
Perfint Healthcare
EU representative : MDSS GmbH (Germany)
India
IIa
93/42
Website
info@perfinthealthcare.com
EUDAMED record
Report an error
Phagenesis FDA
EU representative : Veranex Germany GmbH (Germany)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
info@phagenesis.com
EUDAMED record
Report an error
PHC FDA
EU representative : PHC Europe B.V. (Netherlands)
Japan
IIa
MDR
EUDAMED record
Report an error
Phibo
Spain
IIa
MDR
Website
EUDAMED record
Report an error
Physio-Control FDA
EU representative : Stryker European Operations Limited (Ireland)
United States
IIb
93/42
Website
EUDAMED record
Report an error
PIE
EU representative : SMGeurope OÜ (Estonia)
South Korea
I
MDR
EUDAMED record
Report an error
Pivotal Health Solutions FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Planmeca FDA
Finland
IIa
MDR
EUDAMED record
Report an error
Plenoptika FDA
Spain
IIa
MDR
Website
support@plenoptika.com
EUDAMED record
Report an error
Pmtpartners
Netherlands
I, IIa
MDR
Website
info@pmtpartners.nl
EUDAMED record
Report an error
Polandoptical
Poland
I
MDR
Website
EUDAMED record
Report an error
Precision Vision FDA
EU representative : QNET B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
President Dental
Germany
I, IIa
MDR
Website
info@presidentdental.com
EUDAMED record
Report an error
Prima Medical
EU representative : Obelis s.a. (Belgium)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Prodol Meditec FDA
EU representative : Prodol Meditec S.A. (Spain)
China
I
MDR
Website
info@airtraq.com
EUDAMED record
Report an error
Proi̇mtech Sağlik Ürünleri̇ Anoni̇m Şi̇rketi̇ FDA
Türkiye
IIa
MDR, 93/42
Website
info@bilimplant.com
EUDAMED record
Report an error
Prolira FDA
Netherlands
IIa
MDR
Website
EUDAMED record
Report an error
Proma Medikal Şti
Türkiye
I
MDR
Website
EUDAMED record
Report an error
ProstaLund FDA
Sweden
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Qufu Lekang Medical Technology Group FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Qureshi Manufacturing
EU representative : AF Pharma Service Europe SL (Spain)
Pakistan
I
MDR
info@jaconvena.com
EUDAMED record
Report an error
RDS
France
IIa
MDR
EUDAMED record
Report an error
Re5
Denmark
IIa
MDR
Website
info@re5.com
EUDAMED record
Report an error
Reitel
Germany
I
MDR
Website
info@reitel.com
EUDAMED record
Report an error
Respironics Novametrix
EU representative : Philips Medical Systems Nederland B.V. (Netherlands)
United States
I, IIb
MDR
eudamed@philips.com
EUDAMED record
Report an error
Rgb Medical Devices FDA
Spain
IIb
MDR
Website
EUDAMED record
Report an error
Risenmed FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Riva Muhendislik Su Aritma Sistemleri Şti
Türkiye
IIa, IIb
MDR
info@rivamed.com.tr
EUDAMED record
Report an error
Runner FDA
Italy
IIa
MDR
Website
EUDAMED record
Report an error
RZ-Medizintechnik FDA
Germany
IIa
MDR
Website
info@rz-medizintechnik.com
EUDAMED record
Report an error
SAC(Xiamen) Medical Technology
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Sanitas
Ireland
I
MDR
Website
info@sanitashealthcare.co.uk
EUDAMED record
Report an error
Savir
Germany, Italy
I, IIa
MDR, 93/42
Website
regulatory@savir-center.com
EUDAMED record
Report an error
Sbm Sistemi FDA
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Scaner
EU representative : AFINA, spol.s r.o. (Czechia)
Ukraine
I
MDR
EUDAMED record
Report an error
Schneider Medical
Germany
I
MDR
Website
hello@schneider-medical.com
EUDAMED record
Report an error
Scinomed
EU representative : Scinomed Deutschland GmbH (Germany)
China
IIb
MDR, 93/42
Website
info@scinomedshanghai.com
EUDAMED record
Report an error
Sensible Medical Innovations FDA
EU representative : AR Experts B.V. (Netherlands)
Israel
IIa
93/42
Website
EUDAMED record
Report an error
Senzime FDA
Sweden
I
MDR
Website
EUDAMED record
Report an error
Sh
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
I
MDR
Website
EUDAMED record
Report an error
Shandong Guyue Healthcare Appliance FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shanghai Flower Medical Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
ET100,ET200,ET200A,ET300,ET400, ET500,ET600, ET700,ET800,ET-01B,FD-I,FD-IA, FD-II, FD-III,FD-4,FD-12F,FY-6,FY-3001,FY-3001D, FY-3004,FY-3008D,FL-D4B FL700/700,+C2:C37 FL700/500, FL500/500, FL700/ FL500, FZ700/700, FZ700/500, FZ500/500, FZ700 FZ500, FL720/720, FL720/520, FL520/520, FL520 FL720, FLSX6+6FLK5+3, FLK5, FLk3, FLXYC3/3 FLXYC3, FKWY-L4, FKWY-H4, FKWY-L5, FKWY-H5 FLM1700, etc 2 refs
I
MDR
sales007@flower-med.com
EUDAMED record
Report an error
Shanghai Huifeng Medical Instrument FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Shanghai Oujiahua Medical Instruments
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shanghai SiYi Intelligent Technology FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
Info@siyizn.com
EUDAMED record
Report an error
Shanghai Weyuan Medical Device
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shanxi Jerry Medical Instrument
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa, IIb
MDR
exportsales@sxjerrymed.com
EUDAMED record
Report an error
Shenzhen Benevolence Medical Sci&Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Shenzhen Bestman Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Shenzhen Cofoe Biotechnology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Shenzhen Coreray Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
info@core-ray.com
EUDAMED record
Report an error
Shenzhen Homed Medical Device FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
JLN-MB001,JLN-MB002,JLN-MB003,JLN-MB004,JLN-MB005,JLN-MB008,JLN-MB009,JLN-MB010,JLN-MB011,JLN-MB012 3 refs JLO-1090Si,Galena JLO-390i、JLO-390Si、JLO-590i、JLO-590Si、JLO-1090Si、JLO-190i、JLO-190P 3 refs
IIa, IIb
MDR
Website
info@homedgroup.com
EUDAMED record
Report an error
Shenzhen JCR Medical Technology
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
93/42
EUDAMED record
Report an error
Shenzhen Jermei Medical Device Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
Feelo JM802,JM810, JM811,JM817, JM818,JM821,JM822,JM827, JM828,JM829, JM830,JM832,JM833, JM835,JM836, JM837, JM838,JM839, JM841, JM842,JM843,JM888 2 refs Ultrasound Nebulizer JM-06801 3 refs
IIa
MDR
EUDAMED record
Report an error
Shenzhen Le Medical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
EUDAMED record
Report an error
Shenzhen Zhixin Biomedical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
Website
ra@lifotronic.com
EUDAMED record
Report an error
Shenzhenyuechuan FDA
EU representative : WISELINK MEDICAL, S.L.U. (Spain)
China
I
MDR
Website
info@shenzhenyuechuan.com
EUDAMED record
Report an error
Sidemspa
Italy
IIb
93/42
Website
EUDAMED record
Report an error
Siemens Healthcare FDA
Germany
IIb
MDR
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
Siemens Healthineers FDA
Germany
IIb
MDR
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
Siger FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa, IIb
MDR
EUDAMED record
Report an error
SIGMA Medizin-Technik
Germany
IIa
MDR
EUDAMED record
Report an error
Simai
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa, IIb
93/42
EUDAMED record
Report an error
Sissel
Germany
I
MDR
Website
info@sissel.de
EUDAMED record
Report an error
SNJ FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
EUDAMED record
Report an error
Societe D'Etudes De Recherches Et De Fabrication
France
IIa
MDR
EUDAMED record
Report an error
Softlinkmed
EU representative : Eunitor GmbH (Germany)
China
I
MDR
marketing@softlinkmed.com
EUDAMED record
Report an error
Sorimex
Poland
I
MDR
Website
office@sorimex.pl
EUDAMED record
Report an error
Speclipse FDA
EU representative : Qualrep Services B.V. (Netherlands)
South Korea
IIb
93/42
Website
info@speclipse.com
EUDAMED record
Report an error
Spineguard FDA
France
I, IIa, AIMD
MDR, 90/385, 93/42
Website
EUDAMED record
Report an error
SportMed
Luxembourg
I
MDR
Website
info@mobee.eu
EUDAMED record
Report an error
SQ Innovation
EU representative : AR Experts B.V. (Netherlands)
United States
IIb
MDR
Website
info@sqinnovation.com
EUDAMED record
Report an error
Sterilmed FDA
Türkiye
IIa, IIb
MDR
Website
info@sterilmed.com.tr
EUDAMED record
Report an error
SternMed
Germany
I
MDR
Website
info@sternmed.de
EUDAMED record
Report an error
Stille FDA
Sweden
I
MDR
Website
EUDAMED record
Report an error
Straumann FDA
EU representative : Etkon GmbH (Germany)
Switzerland
IIa
MDR
Website
info@straumann.com
EUDAMED record
Report an error
String
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Substrate HD
France
IIa
MDR
Website
contact@volta-medical.com
EUDAMED record
Report an error
Succio Federico
Italy
I
MDR
Website
info@spacewheel.it
EUDAMED record
Report an error
Sucesores De Manuel García
Spain
I
MDR
Website
EUDAMED record
Report an error
Summus Medical Laser FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
93/42
Website
EUDAMED record
Report an error
Sunlifescience
EU representative : Wellkang Ltd (Northern Ireland)
China
IIb
MDR
eudamed@sunlifescience.com
EUDAMED record
Report an error
Sunmedic
Sweden
IIa
93/42
Website
info@sunmedic.se
EUDAMED record
Report an error
Sunray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Sunstar FDA
EU representative : Sunstar France (France)
Switzerland
I, IIa
93/42
Website
regulatory@ch.sunstar.com
EUDAMED record
Report an error
Suowei
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Supore FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
quality@supore.com
EUDAMED record
Report an error
Surgical International
Netherlands
IIb
93/42
Website
raqa.ptm@tsc-life.com
EUDAMED record
Report an error
Surgimag
EU representative : Advena Limited (Malta)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Surgsci
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
ra@surgsci.com
EUDAMED record
Report an error
Suzhou Melodicare Medical Technology FDA
EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Suzhou Sunmed FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
Website
EUDAMED record
Report an error
Syrma Johari MedTech FDA
EU representative : Obelis s.a. (Belgium)
India
IIa
93/42
Website
EUDAMED record
Report an error
Taiyocorp
EU representative : MedNet EC-REP GmbH (Germany)
Japan
I
MDR
Website
info@opela3.com
EUDAMED record
Report an error
Taizhou Branch of Shanghai Yingdu Industry
EU representative : Prolinx GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Taizhou Wanma Medical Technology
EU representative : REP Europe GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Tandemdiabetes FDA
EU representative : MDSS GmbH (Germany)
United States
III
MDR
EUDAMED record
Report an error
Tatasurgical
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
IIa
MDR
Website
info@tata.com.pk
EUDAMED record
Report an error
Tealthfoshan
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
sales@tealthfoshan.com
EUDAMED record
Report an error
Techartmed
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
terraplasma medical
Germany
IIa
MDR
Website
info@terraplasma-medical.com
EUDAMED record
Report an error
Therenva FDA
France
IIb
MDR
Website
prrc@therenva.com
EUDAMED record
Report an error
Thomson Software Solutions
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
THOTH (Suzhou) Medical Technology
EU representative : Everbiz GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Ticmed
Germany
I
MDR
Website
info@ticmed.de
EUDAMED record
Report an error
Tolu Sadrneshinan Pars
EU representative : Glomin GmbH (Germany)
Iran
I
MDR
info@tosap.ir
EUDAMED record
Report an error
Tomey FDA
EU representative : Tomey GmbH (Germany)
Japan
IIa
93/42
Website
qa.ra@tomey.co.jp
EUDAMED record
Report an error
Tongda Medical Equipment (Zibo)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Top Engineering Sarl
EU representative : QS MEDICAL DEVICE REGISTRATION LTD (Cyprus)
Switzerland
I
MDR
Website
EUDAMED record
Report an error
TOP-RANK Health Care FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Tornier FDA
EU representative : Stryker European Operations Limited (Ireland)
United States
IIa
MDR
Website
RegulatoryAffairsTE@stryker.com
EUDAMED record
Report an error
Tosan Tajhiz
EU representative : Glomin GmbH (Germany)
Iran
I, IIb
MDR
Website
info@tosantajhiz.com
EUDAMED record
Report an error
TransMedics FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Tuodaomed
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
IIa, IIb
MDR
ra@tuodaomed.com
EUDAMED record
Report an error
Tur-Med Hastane Malz San Tic Şti
Türkiye
I
MDR
Website
info@turmedonline.com
EUDAMED record
Report an error
TZ Medical FDA
EU representative : CEpartner4U (Netherlands)
United States
I, IIa
MDR
Website
info@tzmedical.com
EUDAMED record
Report an error
Utahmed FDA
EU representative : Utah Medical Products Ltd (Ireland)
United States
I, IIa
MDR
Website
EUDAMED record
Report an error
Vandermeer
Italy
I
MDR
Website
EUDAMED record
Report an error
Vascular Solutions FDA
EU representative : Teleflex Medical (Ireland)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Veol Medical Technologies FDA
EU representative : Mars Medical (Germany)
India
IIa
MDR
Website
info@veolmedtech.com
EUDAMED record
Report an error
Vermeiren
Belgium
I
MDR
compliance@vermeiren.be
EUDAMED record
Report an error
Vhmed FDA
EU representative : Very Heal Ltd. (Northern Ireland)
China
I
93/42
Website
info@vhmed.com
EUDAMED record
Report an error
Vimex
Poland
I, IIb
MDR
Website
office@vimex.eu
EUDAMED record
Report an error
Viromed Medical
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
Vitalograph FDA
Ireland
IIa
MDR
Website
EUDAMED record
Report an error
Vivosonic FDA
EU representative : MDSS GmbH (Germany)
Canada
I, IIa
MDR
Website
info@vivosonic.com
EUDAMED record
Report an error
Vygon FDA
Italy
IIa
MDR
Website
info@vygon.it
EUDAMED record
Report an error
Wellcomet
Germany
IIa
MDR
Website
PRRC@wellcomet.de
EUDAMED record
Report an error
Wellell FDA
EU representative : Wellell Iberia S.L. (Spain)
Taiwan
IIa
93/42
marketing@wellell.com
EUDAMED record
Report an error
Wenzhou Kangju Medical Instrument FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
93/42
EUDAMED record
Report an error
Withings FDA
France
IIa
MDR
Website
regulatory@withings.com
EUDAMED record
Report an error
Witmedica
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
IIb
93/42
Website
sales@witmedical.com
EUDAMED record
Report an error
WK-MedTec
Germany
I, IIa
MDR
Website
info@wk-medtec.de
EUDAMED record
Report an error
Woodway FDA
EU representative : Woodway GmbH (Germany)
United States
I
MDR
EUDAMED record
Report an error
Wuhan Baso Medical Instruments
EU representative : Eunitor GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Wuxi Jiajian Medical Instrument FDA
EU representative : Caretechion GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
X-Med FDA
Sweden
I
MDR
Website
EUDAMED record
Report an error
Xeek
EU representative : MedNet EC-REP GmbH (Germany)
China
IIa
93/42
Website
service@xeek.cn
EUDAMED record
Report an error
Xiamen Ants-Bro Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
COMFORT PLUS AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110 3 refs Everchek CN10 AS-55A, AS-55G 3 refs
IIa
MDR
sales1@asxd.com.cn
EUDAMED record
Report an error
Xuzhou Taijiang Biological Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
TJ-168A,TJ-168B,TJ-168C, TJULTRAHD-4KA, TJULTRAHD-4KB, TJ-268A, TJ-268B, TJ-268C, TJ-268D, TJ-268E, TJ-268F TJ-6001A, TJ-6001B, TJ-6002A, TJ-6002B, TJ-6003A, TJ-6003B, TJ-6004A, TJ-6004B
I
MDR
EUDAMED record
Report an error
Yigaomedical FDA
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
I, IIa
MDR
EUDAMED record
Report an error
Yiğit Sağlık Araç Ve Gereçleri Paz İth İhr Şti
Türkiye
IIb
MDR
Website
EUDAMED record
Report an error
Yongkang Jinkang Health Equipment Factory FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
sales02@chinajinkang.com
EUDAMED record
Report an error
Yrobot
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Yuejamedical FDA
EU representative : phoenix Medtech GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Zhangjiagang Medi Medical Equipment
EU representative : Sungo Cert GmbH (Germany)
China
MK-D700500ZF(G),MK-D700500ZF,MK-K1000500KL,MK-R700500BW(D),MK-E110WY,MK-E200WY,MK-E500KLA,MK-E300BW,MK-E100HF,MK-E370JD,MK-DL500ZF,MK-E80JD,MK-D500ZF,MK-D700ZF,MK-AL250ZF,MK-B400ZF,MK-B400400ZF,MK-BL400ZF YA-03EH,YA-03E,YA-07EH,YA-05E,YA-01E,YA-09E/YA-10E,YA-07E,YA-02E
I
MDR
EUDAMED record
Report an error
Zhejiang Feiman Medical Technology FDA
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Zhejiang Honsun Medical Technology FDA
EU representative : Sungo Cert GmbH (Germany)
China
HS-OP10,HS-OP10A,HS-OP10B, HS-OP10C,HS-OP10D,HS-OP10E, HS-OP10F,HS-OP10G,HS-OP10H, HS-OP10I,HS-OP10J,HS-OP10K, HS-OP10L,HS-OP10L-C,HS-OP10L-C2, HS-OP10M,HS-OP10N,HS-OP10P, HS-OP10Q,HS-OP10R,HS-OP10S, HS-OP10T,HS-OP10U,HS-OP10W, HS-OP10X,HS-OP10Y,HS-OP10Z HS-OT10,HS-OT10A,HS-OT10B,HS-OT10C, HS-OT10D,HS-OT10E,HS-OT10F, HS-OT10G,HS-OT10H,HS-OT10I, HS-OT10J,HS-OT10K,HS-OT10L, HS-OT10L-C,HS-OT10L-C2,HS-OT10M, HS-OT10N, HS-OT10P,HS-OT10Q, HS-OT10R,HS-OT10S,HS-OT10T, HS-OT10U,HS-OT10W,HS-OT10X, HS-OT10Y,HS-OT10Z
I
MDR
EUDAMED record
Report an error
Zhejiang Shuyou Surgical Instrument FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Zhejiang Soudon View Technology
EU representative : Firsteck Bio Srl. (Italy)
China
I
MDR
EUDAMED record
Report an error
Zhengzhou Dison Instrument Meter
EU representative : Share info GmbH (Germany)
China
IIa
MDR
Website
info@zzdison.com
EUDAMED record
Report an error
Zsrbiomedical FDA
EU representative : Caretechion GmbH (Germany)
China
I, IIa
MDR
EUDAMED record
Report an error
Μεντιγουει Εισαγωγη & Εμπορια Ιατρικων Νοσοκομειοακων Μηχανηματων Μ. Ε.Π.Ε
Greece
III
MDR
Website
EUDAMED record
Report an error
Gn Med
Italy
1 other
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Optos FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIa
MDR, 93/42
EUDAMED record
Report an error
Delbio
EU representative : Delta Electronics (Netherlands) B.V. (Netherlands)
Taiwan
IIa
93/42
Website
EUDAMED record
Report an error
Syntechlaser FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
IIb
93/42
Website
sales@syntechlaser.com
EUDAMED record
Report an error
Berlin Heart FDA
Germany
IIb
MDR
Website
info@berlinheart.de
EUDAMED record
Report an error
Braemar Manufacturing FDA
EU representative : Philips Medical Systems Nederland B.V. (Netherlands)
United States
IIa
93/42
eudamed@philips.com
EUDAMED record
Report an error
CamDiab FDA
EU representative : AR Experts B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIb, III
MDR, 93/42
Website
support@camdiab.com
EUDAMED record
Report an error
Cosinuss FDA
Germany
IIa, IIb
MDR
Website
EUDAMED record
Report an error
Effectum Medical
EU representative : MED-RAS GmbH Regulatory Affairs Service (Germany)
Switzerland
IIa
MDR
Website
info@effectummedical.com
EUDAMED record
Report an error
Electronique Du Mazet FDA
France
I, IIa
MDR
contact@electroniquedumazet.com
EUDAMED record
Report an error
Intermedt
Germany
IIb
93/42
info@intermedt.de
EUDAMED record
Report an error
Lumicare FDA
EU representative : NEO HEALTHIES LIMITED (Ireland)
China
IIb
MDR
service@lumicare.one
EUDAMED record
Report an error
Melatech
Denmark
I
MDR
Website
contact@melatech.io
EUDAMED record
Report an error
Shenzhen Konmed Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Spectranetics FDA
EU representative : Spectranetics International B.V. (Netherlands)
United States
IIb
93/42
eudamed@philips.com
EUDAMED record
Report an error
24sens
Austria
IIa
MDR
Website
office@24sens.at
EUDAMED record
Report an error
3F-Fit Fabricando Faber d.o.o. Beograd-Čukarica
Serbia
IIa
MDR
Website
EUDAMED record
Report an error
6D Tape
Finland
I
MDR
Website
EUDAMED record
Report an error
7Dsurgical FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
IIb
MDR
Website
info@orthofix.com
EUDAMED record
Report an error
A-One Medical Supplies (Shenzhen)
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
I
MDR
EUDAMED record
Report an error
ABI Enterprises
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
EUDAMED record
Report an error
Ablymed
Norway
I
MDR
Website
info@ablymed.com
EUDAMED record
Report an error
Acclaro FDA
EU representative : MDSS GmbH (Germany)
United States
IIb
MDR
Website
customerservice@acclaromd.com
EUDAMED record
Report an error
Accrea
Poland
I
MDR
Website
office@accrea.com
EUDAMED record
Report an error
Ace Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Acerain
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
ActivInsights FDA
EU representative : CEpartner4U (Netherlands)
United Kingdom (ex Northern Ireland)
I
93/42
Website
EUDAMED record
Report an error
Acuderm FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Acurable FDA
EU representative : Acurable SLU (Spain)
United Kingdom (ex Northern Ireland)
IIa
93/42
EUDAMED record
Report an error
adapsia
France
IIa
MDR
Website
contact@adapsia.com
EUDAMED record
Report an error
Adeptwatertech
Denmark
I
MDR
Website
mail@adeptwatertech.com
EUDAMED record
Report an error
Admetec
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
EUDAMED record
Report an error
Advalight FDA
Denmark
IIb
MDR
info@advalight.com
EUDAMED record
Report an error
Advanced Technology Research (A.T.R.) S:R.L
Italy
IIa
MDR
Website
info@atrdental.com
EUDAMED record
Report an error
Aerosoon
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
IIa
MDR
sales03@aerosoon.com
EUDAMED record
Report an error
Aferetica
Italy
IIa
MDR
Website
customer.service@aferetica.com
EUDAMED record
Report an error
Affacare
EU representative : Prolinx GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Agencinox
France
I
MDR
Website
EUDAMED record
Report an error
Agu-punt FDA
Spain
IIa
MDR
EUDAMED record
Report an error
AgVa Healthcare
EU representative : CEpartner4U (Netherlands)
India
IIb
MDR
Website
info@agvahealthtech.com
EUDAMED record
Report an error
Aidite FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
IIa
MDR
info@aidite.com
EUDAMED record
Report an error
Airglove Medical FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@airglovemedical.com
EUDAMED record
Report an error
Aizoi
Italy
IIa
MDR
Website
info@aizoi.com
EUDAMED record
Report an error
AkknaTek
Germany
I
93/42
info@akknatek.com
EUDAMED record
Report an error
Albert FDA
Poland
I
MDR
Website
EUDAMED record
Report an error
Alcor Scientific FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
EUDAMED record
Report an error
Alicn Medical Shenzhen FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
IIa
MDR
Website
EUDAMED record
Report an error
AliveCor FDA
EU representative : Obelis s.a. (Belgium)
United States
IIb
MDR
Website
EUDAMED record
Report an error
Alker medicale
Italy
I
MDR
Website
info@alker.it
EUDAMED record
Report an error
Allcare Innovations FDA
France
I
MDR
Website
contact@allcare-in.com
EUDAMED record
Report an error
Allmed Medical FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Allmed Middle East
EU representative : Allmed Medical GmbH (Germany)
Egypt
I
MDR
Website
EUDAMED record
Report an error
Alpha Omega Engineering FDA
EU representative : Alpha Omega GmbH (Germany)
Israel
I
MDR
Website
EUDAMED record
Report an error
Alrenas
Türkiye
I
MDR
Website
info@alrenas.com
EUDAMED record
Report an error
Alta Lab
Italy
I
MDR
info@altalab.it
EUDAMED record
Report an error
Althea Deutschland
Germany
I
MDR
Website
EUDAMED record
Report an error
Amcaremed
EU representative : MedPath GmbH (Germany)
China
I
MDR
info@amcaremed.com
EUDAMED record
Report an error
Amcube
France
I
MDR
Website
EUDAMED record
Report an error
Amelmedical
Italy
IIa
93/42
EUDAMED record
Report an error
American Diagnostic FDA
EU representative : S.C. Cattus S.R.L. (Romania)
United States
I
MDR
Website
info@adctoday.com
EUDAMED record
Report an error
Aminogram
France
IIa
MDR
Website
contact@aminogram.com
EUDAMED record
Report an error
Amit
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Amity
EU representative : Amity Healthcare EU Ltd. (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
sales@amityinternational.com
EUDAMED record
Report an error
Ampcarellc FDA
EU representative : Obelis s.a. (Belgium)
United States
IIa
MDR
Website
info@ampcarellc.com
EUDAMED record
Report an error
Andent
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
Website
info@andent.cn
EUDAMED record
Report an error
Andromedic
Italy
IIb
MDR
Website
info@andromedic.it
EUDAMED record
Report an error
AnesTek FDA
EU representative : Luana Med. B.V. (Netherlands)
Taiwan
I
MDR
Website
EUDAMED record
Report an error
Aneuvo FDA
EU representative : Obelis s.a. (Belgium)
United States
IIb
MDR
Website
regulatory.affairs@aneuvo.com
EUDAMED record
Report an error
Angiodroid
Italy
IIa
93/42
Website
info@angiodroid.com
EUDAMED record
Report an error
Angionica
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Ankon Medical Technologies (Shanghai)
EU representative : Caretechion GmbH (Germany)
China
IIa
MDR
service@ankoninc.com.cn
EUDAMED record
Report an error
Anle
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
eudamedlogin@anle.cn
EUDAMED record
Report an error
Anping Guardian Medical Equipment FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I
MDR
Website
info@splint.cn
EUDAMED record
Report an error
Ansabere Surgical
Spain
I
MDR
Website
EUDAMED record
Report an error
Antmed FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
IIb
MDR
Website
info@antmed.com
EUDAMED record
Report an error
Anyhomecare FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
AHC-OP01,AHC-OP02,AHC-OP03,AHC-OP04,AHC-OP05,AHC-OP06,AHC-OP07,AHC-OP08,AHC-OP09,AHC-OP10,AHC-OP11,AHC-OP12,AHC-OP13,AHC-OP14,AHC-OP15,AHC-OP16,AHC-OP17,AHC-OP18,AHC-OP19,AHC-OP20,AHC-OP21,AHC-OP22,AHC-OP23,AHC-OP24,AHC-OP24,AHC-OP30,AHC-OP40,AHC-OP50
I
MDR
sales08@anyhomecare.com
EUDAMED record
Report an error
Aort
Türkiye
IIb
MDR
Website
info@aort.net
EUDAMED record
Report an error
Apex Medical FDA
EU representative : SciPharm Sàrl (Luxembourg)
China
IIb
93/42
Website
info@apexdiabetes.com
EUDAMED record
Report an error
APK Technology FDA
EU representative : Ruiyi Healthcare GmbH (Germany)
China
I
MDR
Website
info@apk-technology.com
EUDAMED record
Report an error
Applebiomed
EU representative : MDSS GmbH (Germany)
Taiwan
I
MDR
EUDAMED record
Report an error
Aprikos Medical
Norway
I
MDR
Website
info@aprikosmedical.com
EUDAMED record
Report an error
Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş San Diş Ti̇c Şti̇
Türkiye
I
MDR
EUDAMED record
Report an error
Aquakinetics Bewegung Im Wasser
Germany
I
MDR
Website
info@aqua-kinetics.de
EUDAMED record
Report an error
AR Instrumed
EU representative : AR Instrumed Deutschland GmbH (Germany)
Pakistan
I
MDR
Website
info@ar-instrumed.com
EUDAMED record
Report an error
Archeon FDA
France
I
MDR
Website
contact@archeon-medical.com
EUDAMED record
Report an error
Arden Medical FDA
EU representative : EUCEREP B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
I
MDR
EUDAMED record
Report an error
Ardenne
Germany
IIa
MDR
Website
info@ardenne.de
EUDAMED record
Report an error
Arthrex FDA
EU representative : Arthrex GmbH (Germany)
United States
I, IIa
MDR
Website
EUDAMED record
Report an error
Articares FDA
EU representative : QAdvis EAR AB (Sweden)
Singapore
IIa
MDR, 93/42
Website
qa@articares.com
EUDAMED record
Report an error
Artinis
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Arum Dentistry FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
South Korea
IIa
MDR
EUDAMED record
Report an error
Asel Tibbi Aletler
Türkiye
I
MDR
Website
info@aseltech.com.tr
EUDAMED record
Report an error
Aselsan
Türkiye
III
MDR
Website
EUDAMED record
Report an error
Asleep
EU representative : SOAR & PARTNERS Sp. z o.o. (Poland)
South Korea
I
MDR
EUDAMED record
Report an error
Aspen Medical Products FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
service@aspenmp.com
EUDAMED record
Report an error
Astraia
Germany
IIb
MDR
Website
info@astraia.com
EUDAMED record
Report an error
AthenaDiaX
Germany
IIa
93/42
Website
info@athenadiax.com
EUDAMED record
Report an error
ATLAS medical technologies
Germany
I
MDR
Website
info@atlas4d.de
EUDAMED record
Report an error
Atlascerrahialetler
Türkiye
I
MDR
Website
EUDAMED record
Report an error
ATsens FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIa
93/42
Website
sales@atsens.com
EUDAMED record
Report an error
Auas Instruments
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
I
MDR
EUDAMED record
Report an error
Auckland Medical Polymer (Tianjin)
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Augustecryogenics
Slovakia
IIa
MDR
Website
cs.eu@augustecryogenics.com
EUDAMED record
Report an error
Aurimod
Austria
IIa
MDR, 93/42
Website
office@aurimod.com
EUDAMED record
Report an error
Auritec
Germany
IIa
MDR
EUDAMED record
Report an error
Avan Teb
EU representative : Trionara Technologies AB (Sweden)
Iran
IIb
93/42
Website
info@avanteb.com
EUDAMED record
Report an error
Avatera
Germany
IIb
93/42
Website
regulatory@avateramedical.com
EUDAMED record
Report an error
Awatar
Croatia
IIa
MDR
info@awatar.hr
EUDAMED record
Report an error
Axium MTech
EU representative : Cedic srl (Italy)
Switzerland
IIa
93/42
quality@axium-mtech.com
EUDAMED record
Report an error
Axomove
France
I
MDR
info@axomove.com
EUDAMED record
Report an error
Azistaindustries
EU representative : Obelis s.a. (Belgium)
India
I
MDR
Website
EUDAMED record
Report an error
B&D Bracci e dispositivi
Italy
I
MDR
Website
info@b-d.it
EUDAMED record
Report an error
B.A.C
Italy
I
MDR
Website
info@bactechnology.it
EUDAMED record
Report an error
B.C.Trade
Italy
IIb
MDR
EUDAMED record
Report an error
B.J.ZH.F.Panther Medical Equipment FDA
EU representative : Obelis s.a. (Belgium)
China
IIb
MDR
Website
ra@pantherhealthcare.com
EUDAMED record
Report an error
Balcare
EU representative : Balcare GmbH (Germany)
Switzerland
I
MDR
info@balcare.com
EUDAMED record
Report an error
Baoding Te’anzhou Electronic Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Bark
EU representative : Obelis s.a. (Belgium)
Singapore
IIa
MDR
Website
EUDAMED record
Report an error
Baroks
Türkiye
IIb
93/42
Website
EUDAMED record
Report an error
Bayer FDA
EU representative : Bayer Medical Care B.V. (Netherlands)
United States
IIb
MDR
EUDAMED record
Report an error
Bd FDA
EU representative : Becton Dickinson Ireland Limited (Ireland)
Switzerland
IIb
93/42
Website
EUDAMEDenquiries@bd.com
EUDAMED record
Report an error
Bee-Light Solutions Spółka Z Ograniczoną Odpowiedzialnością
Poland
I
MDR
EUDAMED record
Report an error
Beijing Anchorfree Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
93/42
EUDAMED record
Report an error
Beijing Eternal Medical Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Beijing Hanvon Health Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Beijing Kingst Medical Device FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Beijing Konted Medical Technology FDA
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Beijing L&Z Medical Technology Development FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Beijing LepuImage Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Beijing Neo Science
EU representative : MedNet EC-REP C III GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Beijing Sano Laser S&T Development FDA
EU representative : Prolinx GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Beijing Stelle Laser Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Beijing Target Medical Technologies
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
BEIJING UNT Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Beijing Wanliandaxinke Instruments
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
info@wldyq.com
EUDAMED record
Report an error
BEKA-Hospitec FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Belimed FDA
EU representative : Belimed, pomivalni sistemi d.o.o. (Slovenia)
Switzerland
IIa
MDR
Website
info@belimed.com
EUDAMED record
Report an error
Bellco FDA
Italy
IIb
MDR
EUDAMED record
Report an error
Bertram
Germany
I
MDR
Website
info@bertram.de
EUDAMED record
Report an error
Beyes FDA
EU representative : Lotus NL B.V. (Netherlands)
Canada
IIa
MDR
Website
EUDAMED record
Report an error
BHS Technologies
Austria
I
MDR
Website
office@bhs-technologies.com
EUDAMED record
Report an error
Bilihome
Netherlands
IIa
MDR
Website
regulatory@bilihome.org
EUDAMED record
Report an error
Bio Brem
EU representative : Azienda Tecnica S.r.l. (Italy)
Switzerland
IIa
MDR
info@biobrem.com
EUDAMED record
Report an error
Biobase FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Biobeat Technologies FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
MDR
Website
info@bio-beat.com
EUDAMED record
Report an error
Biodata Devices
Spain
IIa
MDR
Website
EUDAMED record
Report an error
Biodisin
Italy
I
MDR
info@biodisin.com
EUDAMED record
Report an error
Biogenesys
Italy
IIa
93/42
Website
info@biogenesys.it
EUDAMED record
Report an error
Biohorizons FDA
EU representative : ALTATEC GmbH (Germany)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Biomet Orthopedics FDA
EU representative : Biomet Global Supply Chain Center B.V. (Netherlands)
United States
I
MDR
Website
customerservice@zimmerbiomet.com
EUDAMED record
Report an error
Bionix FDA
EU representative : Obelis s.a. (Belgium)
United States
I
MDR
Website
EUDAMED record
Report an error
Bioretina
Türkiye
IIb
MDR
Website
EUDAMED record
Report an error
Biosense Webster (Israel)
EU representative : Biosense Webster A Division of Johnson & Johnson Medical NV/SA (Belgium)
Israel
IIa
MDR
EUDAMED_Enquiries@its.jnj.com
EUDAMED record
Report an error
Biosphere Medical FDA
France
I
93/42
Website
udiadmin@merit.com
EUDAMED record
Report an error
Biotec FDA
Italy
IIb
93/42
info@biotecitalia.com
EUDAMED record
Report an error
Biotechnovations
Italy
I
MDR
info@biotechnovations.com
EUDAMED record
Report an error
Biotekna FDA
Italy
IIa
MDR
EUDAMED record
Report an error
Bioventus FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
regulatory.affairs@bioventus.com
EUDAMED record
Report an error
Bliss Health Products FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Blizzard Protection Systems FDA
EU representative : Comply Express Lda (Portugal)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Blueback
France
I
MDR
Website
contact@blueback.fr
EUDAMED record
Report an error
Bluecorecompany FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Blueraymed
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIb
MDR
EUDAMED record
Report an error
bodyfeed
France
I
MDR
Website
contact@bodyfeedconcept.com
EUDAMED record
Report an error
Bonreemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Bracco FDA
EU representative : ACIST Europe BV (Netherlands)
United States
IIb
93/42
Services.ProfessionalEurope@bracco.com
EUDAMED record
Report an error
BrainCapture
Denmark
IIa
MDR
Website
info@braincapture.dk
EUDAMED record
Report an error
Braincare (Beijing) medical device
EU representative : NEO HEALTHIES LIMITED (Ireland)
China
I
MDR
Website
EUDAMED record
Report an error
Braineye
EU representative : MDSS GmbH (Germany)
Australia
I
MDR
support@braineye.com
EUDAMED record
Report an error
Brainhero
Austria
IIa
MDR
Website
EUDAMED record
Report an error
Brainmaster FDA
EU representative : mdi Europa GmbH (Germany)
United States
IIa
MDR
Website
sales@brainm.com
EUDAMED record
Report an error
BrainsWay FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIb
MDR
Website
info@brainsway.com
EUDAMED record
Report an error
Brav FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
Electronic Blood Pressure Monitor BP-201, BP-202,BP-203, BP-204, BP-205, BP-206,BP-207, BP-208, BP-204C,BP-204A,BP-215, BP-203C,BP-205A,BP-201C, BP-217,BP-202C,BP-205B 3 refs
IIa
MDR
service@brav.com.cn
EUDAMED record
Report an error
Breramedical FDA
Italy
IIb
93/42
Website
EUDAMED record
Report an error
BRH medical FDA
EU representative : Arazy Group (Ireland) Ltd. (Ireland)
Israel
IIa
93/42
Website
info@brhmedical.com
EUDAMED record
Report an error
Britemed FDA
EU representative : Obelis s.a. (Belgium)
Taiwan
IIa
93/42
Website
EUDAMED record
Report an error
BSL FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
I
MDR
EUDAMED record
Report an error
BSN Medical FDA
EU representative : BSN medical GmbH (Germany)
United States
I
MDR
EUDAMED_LAA1_LM_Charlotte@essity.com
EUDAMED record
Report an error
BTC
Italy
I
MDR
EUDAMED record
Report an error
Btm Danişmanlik Sağlik Ve Enerji̇ Yatirimlari Ti̇c Şti̇
Türkiye
I
MDR
Website
info@btmsaglik.com
EUDAMED record
Report an error
Bursetmedikal
Türkiye
IIa
93/42
Website
info@burset.com.tr
EUDAMED record
Report an error
BYTEC Legal Manufacturer FDA
Germany
IIb
93/42
Website
info@bytec-lm.com
EUDAMED record
Report an error
Béké-Bobo
EU representative : AR Experts B.V. (Netherlands)
Canada
I
MDR
Website
EUDAMED record
Report an error
C&V Tech
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
93/42
Website
support@cnvtech.co.kr
EUDAMED record
Report an error
C-Pro Direct FDA
EU representative : C-Pro Direct Ireland Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
enquiries@c-prodirect.com
EUDAMED record
Report an error
C-Tech Implant
Italy
IIa
MDR
info@c-tech-implant.com
EUDAMED record
Report an error
Caesarea Medical Electronics
EU representative : Becton Dickinson Ireland Limited (Ireland)
Israel
IIb
93/42
EUDAMEDenquiries@bd.com
EUDAMED record
Report an error
Calmedica
France
IIa
MDR
Website
contactus@calmedica.com
EUDAMED record
Report an error
Calvo Izquierdo
Spain
I
MDR
Website
admin@calvoizquierdo.es
EUDAMED record
Report an error
Capintec FDA
EU representative : Atlantico Systems, Ltd. (Ireland)
United States
I
MDR
Website
EUDAMED record
Report an error
Captiks
Italy
I
MDR
info@captiks.com
EUDAMED record
Report an error
CardiacSense FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
IIa
MDR
Website
EUDAMED record
Report an error
Cardiawave
France
IIb
MDR
Website
contact@cardiawave.com
EUDAMED record
Report an error
CardioFocus FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
information@cardiofocus.com
EUDAMED record
Report an error
Cardiohis
Spain
IIa
MDR
info@cardiohis.com
EUDAMED record
Report an error
Cardiomedeurope
Greece
I
MDR
Website
EUDAMED record
Report an error
Care & Cure Surgico
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
info@carecuresurgico.com
EUDAMED record
Report an error
Care Lamps
EU representative : CMC Medical Devices & Drugs SL (Spain)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
support@carelamps.com
EUDAMED record
Report an error
Careliv
Germany
I
MDR
info@careliv.de
EUDAMED record
Report an error
CARER Medical Technology
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Carilex Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
Taiwan
IIb
MDR
Website
EUDAMED record
Report an error
Carima Solutions
Spain
I
MDR
Website
info@carimatech.com
EUDAMED record
Report an error
Castagna Vincenzo
Italy
IIa
93/42
Website
info@twe-italia.com
EUDAMED record
Report an error
Cavallarosrl
Italy
I
MDR
Website
EUDAMED record
Report an error
CBC (Europe)
Italy
IIb
MDR
Website
sales@cbceurope.it
EUDAMED record
Report an error
Cemho FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Centre Barbara Schardt e.K
Germany
I
MDR
Website
info@centre-europa.de
EUDAMED record
Report an error
Centrel
Italy
I
MDR
Website
info@centrel.com
EUDAMED record
Report an error
Centro de Tecnología Biomédica - UPM
Spain
IIa
MDR
EUDAMED record
Report an error
Centurion Medical Products F K A Centurion Medical Products
EU representative : Medline International France (France)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Chamfond FDA
EU representative : Llins Service & Consulting GmbH (Germany)
China
I
MDR
Website
customerservice@chamfond.com.cn
EUDAMED record
Report an error
Changzhou Wenyu Medical Instruments FDA
EU representative : Humiss Beratung GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Cheiron
Czechia
IIa
MDR
Website
EUDAMED record
Report an error
Chengdu WBL UEST New Tech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
ChoiceTech
EU representative : AR Experts B.V. (Netherlands)
South Korea
I
MDR
sales@choicetech.kr
EUDAMED record
Report an error
Cidelec
France
IIa
MDR
Website
info@cidelec.net
EUDAMED record
Report an error
Cimpax FDA
Denmark
I
MDR
Website
ra@cimpax.com
EUDAMED record
Report an error
Cipher Surgical FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
info@ciphersurgical.com
EUDAMED record
Report an error
Circinus Medical Technologies
EU representative : MedEnvoy Global BV (Netherlands)
United States
IIb
MDR
Website
EUDAMED record
Report an error
Circius Pharma FDA
Sweden
IIa
MDR
Website
info@circiuspharma.com
EUDAMED record
Report an error
Clarteis FDA
France
IIb
MDR
contact@clarteis.com
EUDAMED record
Report an error
CLB
Netherlands
IIb
93/42
Website
info@clb.nl
EUDAMED record
Report an error
Cleanhearing
Austria
IIa
93/42
Website
EUDAMED record
Report an error
ClearLake-Tech FDA
EU representative : MDSS GmbH (Germany)
United States
I
MDR
Website
info@clearlake-tech.com
EUDAMED record
Report an error
ClearPoint Neuro FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
regulatory@clearpointneuro.com
EUDAMED record
Report an error
ClearStream Technologies
Ireland
IIb
93/42
Website
EUDAMED record
Report an error
Clinical Innovations FDA
EU representative : MVF (France)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Coala Solutions
Sweden
IIa
MDR
Website
info@coalasolutions.com
EUDAMED record
Report an error
Coltene FDA
EU representative : Coltène/Whaledent GmbH + Co. KG (Germany)
United States
I
MDR
Website
info.us@coltene.com
EUDAMED record
Report an error
Combat Medical
EU representative : Biosurgical S.L (Spain)
United Kingdom (ex Northern Ireland)
IIb
93/42
Website
contact@combat-medical.com
EUDAMED record
Report an error
Community Dermatology
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
support@mapmymole.com
EUDAMED record
Report an error
Compremium FDA
EU representative : MedNet EC-REP GmbH (Germany)
Switzerland
IIa
MDR
Website
info@compremium.ch
EUDAMED record
Report an error
conceptnatal
Germany
I
MDR
Website
info@conceptnatal.de
EUDAMED record
Report an error
Concord Neonatal
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Control Bionics FDA
EU representative : Compliance Management Solutions Europe LTD (Bulgaria)
United States
I
MDR
EUDAMED record
Report an error
ConvaTec FDA
EU representative : Unomedical A/S (Denmark)
United Kingdom (ex Northern Ireland)
I, IIa
MDR
qualitysystems@convatec.com
EUDAMED record
Report an error
Cordiana FDA
EU representative : QAdvis EAR AB (Sweden)
Switzerland
IIa
93/42
Website
info@cordiana.com
EUDAMED record
Report an error
Coriton FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
I
MDR
Website
info@coriton.com
EUDAMED record
Report an error
Corsano FDA
Netherlands
IIa
MDR
info@corsano.com
EUDAMED record
Report an error
Cortrium
Denmark
IIa
MDR, 93/42
Website
eudamed@cortrium.com
EUDAMED record
Report an error
CranioMandibular Rehab FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
I
MDR
Website
support@craniorehab.com
EUDAMED record
Report an error
Crest Medical
EU representative : CMC Medical Devices & Drugs SL (Spain)
United Kingdom (ex Northern Ireland)
I
MDR
Website
quality@crestmedical.co.uk
EUDAMED record
Report an error
Cryoiq FDA
Sweden
I
MDR
Website
info@cryoiq.com
EUDAMED record
Report an error
CSM Implant FDA
EU representative : Specculo Limited (Malta)
South Korea
IIa
MDR
Website
csmheunghb@gmail.com
EUDAMED record
Report an error
Current Health FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
EUDAMED record
Report an error
Custom Software & Electronics
Spain
IIa
MDR
Website
service@medicalcse.com
EUDAMED record
Report an error
Cvn
Finland
I
MDR
Website
EUDAMED record
Report an error
Cylite Pty FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Australia
IIa
MDR
info@cyliteoptics.com
EUDAMED record
Report an error
Cynteract
Germany
I
MDR
Website
info@cynteract.com
EUDAMED record
Report an error
Daeyomedi
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Dakewe FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
Website
EUDAMED record
Report an error
Dalla Valle Andrea
Italy
I
MDR
EUDAMED record
Report an error
Dalumedical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
Website
quality@charamedical.com
EUDAMED record
Report an error
Dam FDA
Italy
IIa
93/42
Website
info@saunaitalia.com
EUDAMED record
Report an error
Daol Med
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
MDR
Website
sales@daolmed.co.kr
EUDAMED record
Report an error
DCI International FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
customerservice@dcionline.com
EUDAMED record
Report an error
de Götzen FDA
Italy
I
MDR
Website
qualitydegotzen@acteongroup.com
EUDAMED record
Report an error
DeepX Health FDA
EU representative : Medical Device Management Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Dehag
Germany
I
MDR
Website
info@dehag.com
EUDAMED record
Report an error
Delsys FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United States
I
MDR
Website
quality@delsys.com
EUDAMED record
Report an error
Demax FDA
EU representative : Obelis s.a. (Belgium)
China
IIa
MDR
EUDAMED record
Report an error
DeMeTec
Germany
IIa
93/42
Website
EUDAMED record
Report an error
Denova
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
Dental Imaging Technologies FDA
EU representative : PaloDEx Group Oy (Finland)
United States
I
MDR
EUDAMED record
Report an error
Dentium FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIa
MDR
EUDAMED record
Report an error
Dentsply FDA
Germany
I
MDR
Website
info.konstanz@dentsplysirona.com
EUDAMED record
Report an error
Dentsply Caulk
EU representative : Dentsply DeTrey GmbH (Germany)
United States
I
MDR
Website
EUDAMED record
Report an error
Detro Healthcare Ki̇mya Sanayi̇ Anoni̇m Şi̇rketi̇
Türkiye
IIb
MDR
Website
EUDAMED record
Report an error
Deutsche Augenoptik
Germany
I
MDR
Website
EUDAMED record
Report an error
DeVilbiss Healthcare FDA
EU representative : Drive Medical GmbH & Co. KG (Germany)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Deymed FDA
Czechia
IIa
MDR
Website
regulatory@deymed.com
EUDAMED record
Report an error
Dfmedica
Italy
I
MDR
Website
EUDAMED record
Report an error
Diagnostic Green FDA
Germany
I
MDR
info@diagnosticgreen.com
EUDAMED record
Report an error
Diagonal Medical Esthetic
Spain
IIa
93/42
Website
info@asirox.com
EUDAMED record
Report an error
Digital Life Line Pte
EU representative : Advena Limited (Malta)
Singapore
I
MDR
Website
EUDAMED record
Report an error
Diopsys
EU representative : Obelis s.a. (Belgium)
United States
IIa
93/42
Website
regulatory@opzira.com
EUDAMED record
Report an error
Discher
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Distalmotion FDA
EU representative : Distalmotion Deutschland GmbH (Germany)
Switzerland
I, IIb
MDR
Website
info@distalmotion.com
EUDAMED record
Report an error
Distributed Medical
Sweden
I
MDR
Website
info@distributedmedical.com
EUDAMED record
Report an error
Dkl
Germany
IIa
MDR
Website
info@dkl.de
EUDAMED record
Report an error
dms-service FDA
EU representative : QNET B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
DNHmedtech
EU representative : CALMED INVEST Kft. (Hungary)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Doccheck
Germany
I
MDR
EUDAMED record
Report an error
Dongjilian FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
sales9@dongjilian.com
EUDAMED record
Report an error
Dpemed FDA
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
Website
info@dpemed.com
EUDAMED record
Report an error
dpv-analytics
Germany
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Drsapporo
Poland
I
MDR
Website
EUDAMED record
Report an error
DS Dental Supply
Germany
I
MDR
eudamed@ds-dental-supply.productions
EUDAMED record
Report an error
Ds Medica
Italy
I
MDR
info@dsmedica.info
EUDAMED record
Report an error
Duearity FDA
Sweden
IIa
MDR
Website
EUDAMED record
Report an error
Dufner Instrumente FDA
Germany
I
MDR
Website
info@dufner-tuttlingen.de
EUDAMED record
Report an error
DXM FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
I
MDR
qa@dxm.co.kr
EUDAMED record
Report an error
DynaMedic FDA
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
MDR
Website
sales@dynamedic.co.kr
EUDAMED record
Report an error
Dynamic Metrics
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
93/42
Website
contact@dynamicmetrics.com
EUDAMED record
Report an error
DYSIS Medical
EU representative : DYSIS MEDICAL ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΣΜΟΥ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ (EL)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
EUDAMED record
Report an error
e-life International FDA
EU representative : MDSS GmbH (Germany)
Taiwan
I
MDR
Website
info@e-lifebracing.com
EUDAMED record
Report an error
Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş
Türkiye
I
MDR
Website
info@ecemedikal.com.tr
EUDAMED record
Report an error
Ecential Robotics FDA
France
IIb
93/42
contact@ecential-robotics.com
EUDAMED record
Report an error
Ecg1Msrl
Italy
IIa
MDR
EUDAMED record
Report an error
Echo-Son
Poland
IIa
MDR
Website
info@echoson.eu
EUDAMED record
Report an error
Eco Physics
EU representative : ECO PHYSICS GmbH (Germany)
Switzerland
IIa
MDR
Website
info@ecophysics.com
EUDAMED record
Report an error
Eco3
Italy
IIa
MDR
Website
EUDAMED record
Report an error
EDGE Surgical Solutions
Italy
I
MDR
EUDAMED record
Report an error
Eduard Gerlach
Germany
I
MDR
info@gehwol.de
EUDAMED record
Report an error
Eicmed
Germany
I
MDR
Website
info@eicmed.de
EUDAMED record
Report an error
Eitan Medical FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Israel
IIb
MDR
support@eitanmedical.com
EUDAMED record
Report an error
eKare FDA
EU representative : Atlantico Systems, Ltd. (Ireland)
United States
I
MDR
Website
info@ekareinc.com
EUDAMED record
Report an error
Ekliptik
Slovenia
IIa
93/42
info@ekliptik.si
EUDAMED record
Report an error
EKOVUK MEDI, s.r.o
Czechia
IIa
MDR
Website
info@pneuven.cz
EUDAMED record
Report an error
ELCON Medical Instruments
Germany
I
MDR
Website
info@elcon-medical.de
EUDAMED record
Report an error
Elemenic FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIb
MDR
Website
EUDAMED record
Report an error
Elits Group
Italy
IIb
93/42
EUDAMED record
Report an error
elliquence FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
quality@elliquence.com
EUDAMED record
Report an error
Elmedical
EU representative : MedNet EC-REP GmbH (Germany)
Israel
IIa
MDR
Website
EUDAMED record
Report an error
Elosan
EU representative : Elosan GmbH (Liechtenstein)
Switzerland
IIa
MDR
Website
info@elosan.com
EUDAMED record
Report an error
Emoled FDA
Italy
IIa
MDR
Website
EUDAMED record
Report an error
EMOS Technology
Germany
IIa
MDR
Website
info@emostechnology.com
EUDAMED record
Report an error
emotion fitness
Germany
IIa
MDR
Website
info@emotion-fitness.de
EUDAMED record
Report an error
Enbio FDA
EU representative : RQS Wojciech Roman (Poland)
Poland, Switzerland
IIa
MDR
Website
info@enbio.com
EUDAMED record
Report an error
Endoscope-i
EU representative : CERT3GLOBAL, UNIPESSOAL, LDA. (Portugal)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Enova Illumination FDA
EU representative : Advena Limited (Malta)
United States
I
MDR
support@enovaillumination.com
EUDAMED record
Report an error
Enproject Medicali
Italy
I
MDR
Website
EUDAMED record
Report an error
Enteralaccesstech FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
93/42
Website
info@enteralaccesstech.com
EUDAMED record
Report an error
Erchonia FDA
EU representative : Advena Limited (Malta)
United States
IIa
MDR
EUDAMED record
Report an error
Ergosurg
Germany
I
93/42
Website
info@ergosurg.com
EUDAMED record
Report an error
Eryigittibbicihazlar
Türkiye
I
MDR
Website
EUDAMED record
Report an error
ETT
Italy
I
MDR
Website
EUDAMED record
Report an error
Eunsung Global FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIb
MDR
Website
EUDAMED record
Report an error
Euromi FDA
Belgium
IIb
MDR
Website
info@euromi.com
EUDAMED record
Report an error
Evans (Instruments)
EU representative : VeriSafe Compliance Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
sales@evansinstruments.co.uk
EUDAMED record
Report an error
eveia
France
I
MDR
Website
EUDAMED record
Report an error
Everaid FDA
EU representative : Ferrer Internacional, S.A. (Spain)
South Korea
IIb
93/42
EUDAMED record
Report an error
Eversion
Germany
I
MDR
Website
EUDAMED record
Report an error
Evertone
EU representative : MedNet EC-REP GmbH (Germany)
Australia
I, IIa
MDR
Website
EUDAMED record
Report an error
Everyway Medical Instrument FDA
EU representative : Luana Med. B.V. (Netherlands)
Taiwan
I
MDR
EUDAMED record
Report an error
EVEX Deutschland
Germany
I
MDR
Website
info@ipro.de
EUDAMED record
Report an error
ExamVision FDA
Denmark
I
MDR
Website
Compliance@ExamVision.com
EUDAMED record
Report an error
Excelsius Medical
EU representative : Excelsius Medical GmbH (Germany)
Taiwan
IIb
93/42
Website
marketing@excelsius-medical.com
EUDAMED record
Report an error
Expo Italia
Italy
IIb
MDR
Website
EUDAMED record
Report an error
Exxentric
Sweden
I
MDR
Website
info@exxentric.com
EUDAMED record
Report an error
Eyerising International
EU representative : Compliance Management Solutions Europe LTD (Bulgaria)
Australia
IIa
MDR
EUDAMED record
Report an error
EyeSense
Germany
IIb
MDR
info@eyesense.com
EUDAMED record
Report an error
Eyoto FDA
EU representative : MedNet EC-REP GmbH (Germany)
United Kingdom (ex Northern Ireland)
I
MDR
Website
sales@eyoto.com
EUDAMED record
Report an error
EZ-Care Solution
EU representative : AF Pharma Service Europe SL (Spain)
Taiwan
I
MDR
Website
info@gumt.com.tw
EUDAMED record
Report an error
Ezygain
France
I
MDR
contact@ezygain.com
EUDAMED record
Report an error
F&B International
Italy
IIa
MDR
EUDAMED record
Report an error
Fairfax Medical Products FDA
EU representative : MD REPS Ltd (Northern Ireland)
United Kingdom (ex Northern Ireland)
IIa
93/42
Website
info@stabident.com
EUDAMED record
Report an error
Falcon Surgical FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Famos
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Feetme
France
I
93/42
Website
contact@feetme.fr
EUDAMED record
Report an error
FeiGuang Vision Technology (Nanjing)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Fengh Medical FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
customerservice@fenghmedical.com
EUDAMED record
Report an error
Fepdon
EU representative : JOYSUN GROUP S.L.U (Spain)
China
I
MDR
EUDAMED record
Report an error
Fidia Farmaceutici FDA
Italy
IIb
93/42
Website
EUDAMED record
Report an error
Fima Global Brands
EU representative : GLORY-Cosmetic Hungary Kft. (Hungary)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@fima-global.com
EUDAMED record
Report an error
Findex
EU representative : Rexxam Co., Ltd. Netherlands Office (Netherlands)
Japan
I
MDR
EUDAMED record
Report an error
Fiorentino A.M
Italy
I
MDR
EUDAMED record
Report an error
First Scientific Dental
Germany
I
MDR
eudamed@first-scientific.de
EUDAMED record
Report an error
First Scientific Dental Materials
Germany
I
MDR
eudamed@oxford-scientific.de
EUDAMED record
Report an error
Firstar FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Fisiotech
Italy
I
MDR
Website
info@fisiotech.com
EUDAMED record
Report an error
FIZE Medical FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
MDR
Website
EUDAMED record
Report an error
Flosonicsmedical FDA
EU representative : Advena Limited (Malta)
Canada
IIa
MDR
info@flosonicsmedical.com
EUDAMED record
Report an error
Focusmed
Italy
IIb
MDR
Website
admin@focusmed.it
EUDAMED record
Report an error
Formatk FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Israel
IIa
MDR
Website
info@formatk.co.il
EUDAMED record
Report an error
Formedsurgical
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
Website
info@formedsurgical.com
EUDAMED record
Report an error
Fort Metal Plastic Products Huizhou
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Fortuna Healthcare
EU representative : Fortuna Healthcare (Ireland) Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@fortunahealthcare.eu
EUDAMED record
Report an error
Foshan Akos Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
Website
info@akosdent.com
EUDAMED record
Report an error
Foshan ANYE Medical Apparatus Technology
EU representative : Share info GmbH (Germany)
China
AY-215A1,AY-215A2,AY-215A3,AY-215A5,AY-215B1,AY-215B2,AY-215B3,AY-215B5,AY-215C1,AY-215C2,AY-215C3,AY-215C5,AY-215D1,AY-215D2,AY-215D3,AY-215E1,AY-215E2,AY-215E3 3 refs
IIa
MDR
EUDAMED record
Report an error
Foshan Gaunying Electronics FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Foshan Huafukang Medical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Foshan Keju Medical Apparatus
EU representative : Share info GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Foshan Kexiang Medical Instrument
EU representative : Share info GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Foshan Keyhub Electronic Industries
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
93/42
Website
EUDAMED record
Report an error
Foshan Maile Medical Apparatus
EU representative : Share info GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Foshan VinponG Medical Technology
EU representative : Share info GmbH (Germany)
China
WB221-G1,WB221-G2,WB221-G3,WB221-G5,WB221-G6,WB221-G7,WB221-G8,WB221-G9,WB221-G10,WB221-G11,WB221-G12,WB221-G13 3 refs
IIa
MDR
EUDAMED record
Report an error
Foshan ZIANN Medical Apparatus
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Fri.Med
Italy
IIa
MDR
EUDAMED record
Report an error
Fujiflex
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Japan
I
MDR
info@fuji-flex.co.jp
EUDAMED record
Report an error
Full Vision FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Futurtec
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Fysicon FDA
Netherlands
IIb
MDR
Website
info@fysicon.com
EUDAMED record
Report an error
Fysiomed
Belgium
IIa
93/42
Website
info@fysiomed.com
EUDAMED record
Report an error
G&Z Instrumente
Austria
IIa
MDR
Website
office@g-z-i.at
EUDAMED record
Report an error
G2E
EU representative : Advena SRL (Italy)
South Korea
IIb
MDR
Website
EUDAMED record
Report an error
Gamida Tech
France
IIb
MDR
EUDAMED record
Report an error
Gardhen Bilance
Italy
I
MDR
Website
info@gardhenbilance.it
EUDAMED record
Report an error
Gasn2
Spain
IIb
MDR
Website
EUDAMED record
Report an error
GAUKE Healthcare FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
Website
info@gaukefirstaidkit.com
EUDAMED record
Report an error
Gavimedica
Italy
I
MDR
Website
EUDAMED record
Report an error
GBUK Group FDA
EU representative : Qualrep Services B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
I
MDR
Website
customerservices@gbukgroup.com
EUDAMED record
Report an error
Gedoc
Sweden
I
MDR
Website
information@gedoc.se
EUDAMED record
Report an error
General Europe Vacuum
Italy
IIb
93/42
Website
info@gevac.com
EUDAMED record
Report an error
General Meditech FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
93/42
Website
EUDAMED record
Report an error
Germitec FDA
France
IIb
93/42
prrc@germitec.com
EUDAMED record
Report an error
Geuder FDA
Germany
IIb
MDR
Website
info@geuder.de
EUDAMED record
Report an error
GF Health Products FDA
EU representative : CEpartner4U (Netherlands)
United States
I
MDR
Website
cs@grahamfield.com
EUDAMED record
Report an error
GGz Centraal
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Ghimas FDA
Italy
IIa
93/42
Website
EUDAMED record
Report an error
Gialdi
Italy
I
MDR
Website
info@gialdi.it
EUDAMED record
Report an error
Glaswarenfabrik Karl Hecht
Germany
I
MDR
Website
EUDAMED record
Report an error
Global Surgical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
customerservice@globalsurgical.com
EUDAMED record
Report an error
Goang Hann Enterprise FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
I
MDR
EUDAMED record
Report an error
Gocengmed
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Godius
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIb
MDR
EUDAMED record
Report an error
Goldenall FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Goldenseason FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Singapore
I
MDR
Website
EUDAMED record
Report an error
Goodlymed FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
GOTOP Medical FDA
EU representative : Atlantico Systems, Ltd. (Ireland)
United States
IIa
MDR
Website
info@gotopmedical.com
EUDAMED record
Report an error
Greens Surgicals FDA
EU representative : Obelis s.a. (Belgium)
India
I
MDR
Website
info@greensurgicals.com
EUDAMED record
Report an error
Gruppo Audiologico
Italy
I
MDR
commerciale@gruppoaudiologico.com
EUDAMED record
Report an error
Guangdong Hongke Medical Technology
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Guangdong Kui Luk Medical Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Integral dental unit K2, K3, K4, K5, K6, K6P, K7, K7P, K8, K8P, K9 3 refs
IIa
MDR
Website
EUDAMED record
Report an error
Guangdong Yadeng Medical Apparatus FDA
EU representative : Share info GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Guangzhou Nuoning Medical Supplies FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Guangzhou Oci Medical Devices
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Guangzhou Phoenix Medical Equipment
EU representative : MedNet EC-REP C IIb GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Guangzhou Qiushi Medical Equipment
EU representative : HUMISS TRADING S. L. (Spain)
China
I
MDR
EUDAMED record
Report an error
Guilin InnoGen Medical Technology
EU representative : MedPath GmbH (Germany)
China
I
MDR
info@ig-med.com
EUDAMED record
Report an error
Guilin Kevin Peter Technology FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Guilin Yahope Medical Technology
EU representative : MedNet EC-REP GmbH (Germany)
China
I
MDR
Website
EUDAMED record
Report an error
Guilin Yikeshi Medical Instrument FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Gym80
Germany
I
MDR
Website
EUDAMED record
Report an error
Gynius
Sweden
I
MDR
Website
info@gynius.se
EUDAMED record
Report an error
H O Equipments FDA
Belgium
IIa
MDR
Website
info@ho-equipments.com
EUDAMED record
Report an error
H.S. Hospital Service FDA
Italy
IIb
93/42
Website
EUDAMED record
Report an error
Hadleighhealth FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
93/42
Website
EUDAMED record
Report an error
Hahnenkratt FDA
Germany
IIa
MDR
Website
info@hahnenkratt.com
EUDAMED record
Report an error
Hai Hong Base Industry Science Technology Development Harbin China
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Haier
EU representative : Share info GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Haier Haematologi Chongqing
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Haiyan Kangyuan Medical Instrument FDA
EU representative : Eunitor GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Hamamatsu
EU representative : Hamamatsu Photonics Deutschland GmbH (Germany)
Japan
I
MDR
Website
sales@sys.hpk.co.jp
EUDAMED record
Report an error
Hamilton Medical FDA
EU representative : medin Medical Innovations GmbH (Germany)
Switzerland
IIb
MDR
Website
regulatory.med.global@hamilton-medical.com
EUDAMED record
Report an error
Hangzhou Ruidi Biotechnology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIb
MDR
EUDAMED record
Report an error
Hangzhou Tonglu Medical Optical Instrument
EU representative : HUMISS TRADING S. L. (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Hangzhou Universal Electronic FDA
EU representative : Share info GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Hangzhou Xinrun Medical Technology
EU representative : Everbiz GmbH (Germany)
China
IIa
MDR
Website
export@furunmed.com
EUDAMED record
Report an error
Hankamp Rehab
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Hansol Medical FDA
EU representative : Meridius Medical Europe Limited (Ireland)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Hansung FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
Hapticlink
Netherlands
I
MDR
info@hapticlink.nl
EUDAMED record
Report an error
Harbin BOOYUN Medical Instrument
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Harbin Hengwei Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Harbin Jingkeqi Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
sales@hrbjkq.com
EUDAMED record
Report an error
Harbin Zhengda Medical Equipment Manufacturing
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Harvard Dental International
Germany
I
MDR
Website
eudamed@harvard-dental-international.de
EUDAMED record
Report an error
Hash-Tech
Germany
I
MDR
Website
EUDAMED record
Report an error
Health Care Systems
Germany
IIa
MDR
EUDAMED record
Report an error
Healthium Medtech FDA
EU representative : Meddevices Lifesciences B.V. (Netherlands)
India
IIa
MDR
EUDAMED record
Report an error
Healthplussh
EU representative : Everbiz GmbH (Germany)
China
I
MDR
sales@healthplussh.com
EUDAMED record
Report an error
HeartHero
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
93/42
Website
info@hearthero.com
EUDAMED record
Report an error
Hearthpilates
Italy
I
MDR
EUDAMED record
Report an error
Hebei Vimed Medical Device FDA
EU representative : Supporting Health Care N.V. (Netherlands)
China
I-Scoop Video laryngoscope/Model: I-Scoop 200 PVL-I-01,PVL-I-01 Plus,PVL-I-02,PVL-I-02 Plus,PVL-I-01 Plus-IB,PVL-I-02 Plus-IB,MC2001,MC2001 Plus,MC2002,MC2002 Plus,VM110,VM1101,VM1102,VM120,VM1201,VM1202 3 refs
I
MDR
Website
EUDAMED record
Report an error
Hebei Webian Medical Instrument Trading FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Hefei Kangjuren Medical Device Technology
EU representative : Share info GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Heltschl
Austria
IIa
93/42
Website
office@heltschl.at
EUDAMED record
Report an error
Hemselec FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Henan Tuoren Medical Device FDA
EU representative : MedNet EC-REP C III GmbH (Germany)
China
IIb
MDR
info@bjtuoren.com
EUDAMED record
Report an error
HeraMED FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
93/42
Website
info@hera-med.com
EUDAMED record
Report an error
HERRMANN Apparatebau
Germany
IIb
MDR
Website
info@hab.gmbh
EUDAMED record
Report an error
hestomed
Germany
IIb
MDR
Website
EUDAMED record
Report an error
Heyer Care
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Hicren
EU representative : Caretechion GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Hidrex FDA
Germany
IIa
93/42
Website
info@hidrex.de
EUDAMED record
Report an error
Hidroxa FDA
Sweden
IIa
MDR
Website
EUDAMED record
Report an error
Hilbro International FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
sales.hilbrointl@gmail.com
EUDAMED record
Report an error
HIPP Medical FDA
Germany
IIa
MDR
Website
info@hipp-medical.com
EUDAMED record
Report an error
Hippo Medical Pte
EU representative : PureCE B.V. (Netherlands)
Singapore
IIb
MDR
EUDAMED record
Report an error
HippoScreen Neurotech FDA
EU representative : Luana Med. B.V. (Netherlands)
Taiwan
IIa
MDR
EUDAMED record
Report an error
Hironic FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
Website
ra@hironic.com
EUDAMED record
Report an error
Hisense FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIb
93/42
EUDAMED record
Report an error
Hmc Premedical FDA
Italy
IIa
MDR
Website
info@hmcgroup.it
EUDAMED record
Report an error
Honeywell FDA
Germany
IIb
MDR
Website
EUDAMED record
Report an error
Honyatt
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Hopebotics
EU representative : MedNet EC-REP GmbH (Germany)
Hong Kong SAR China
I
MDR
Website
info@hopebotics.org
EUDAMED record
Report an error
Hospital Equipment Mfg FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
I
MDR
Website
info@hemcmedical.com
EUDAMED record
Report an error
Hospotica
Italy
IIb
MDR
Website
info@hospotica.it
EUDAMED record
Report an error
HP Medizintechnik
Germany
IIa
93/42
Website
EUDAMED record
Report an error
Huahui (Guangdong) Medical Technology
EU representative : Share info GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Hualve
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Huawei
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
Website
EUDAMED record
Report an error
Hunan Greatmade Medical Tech
EU representative : SUNGO Europe B.V. (Netherlands)
China
Connector CF001A, CF002A, CF003A, CF004A, CF004LA, CF004TA, CF001B, CF002B, CF003B, CF004B, CF004LB, CF004TB, CF001A-V, CF002A-V, CF003A-V, CF004A-V, CF004LA-V, CF004TA-V, CF001B-V, CF002B-V, CF003B-V, CF004B-V, CF004LB-V, etc 3 refs
I
MDR
EUDAMED record
Report an error
Hunan Jianyuan Medical Science Technology FDA
EU representative : Caretechion GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Hunan Nine Stars Intelligent Medical Equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Hyb
Slovenia
IIb
93/42
EUDAMED record
Report an error
Hydas
Germany
I
MDR
Website
eudamed@hydas.de
EUDAMED record
Report an error
Hygenic FDA
EU representative : AR Experts B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Hytech-Pommec
Netherlands
IIb
MDR
EUDAMED record
Report an error
Hörzentrum Oldenburg gGmbH
Germany
IIa
MDR, 93/42
Website
info@hz-ol.de
EUDAMED record
Report an error
IBD Italian Biomedical Devices
Italy
IIb
MDR
info@ibdsrl.com
EUDAMED record
Report an error
Ibex
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Icumed FDA
EU representative : ICU Medical BV (Netherlands)
United States
I
MDR
Website
customerservice@icumed.com
EUDAMED record
Report an error
Icutech
Poland
IIa
MDR
Website
info@icutech.pl
EUDAMED record
Report an error
Identites
France
I
MDR
Website
serviceclient@identites.tm.fr
EUDAMED record
Report an error
Idiag
EU representative : Idiag GmbH (Germany)
Switzerland
I
MDR
Website
info@idiag.ch
EUDAMED record
Report an error
Idoman Teoranta FDA
Ireland
IIb
93/42
Website
customerservice@idoman-med.com
EUDAMED record
Report an error
Idrom LT
Spain
IIb
93/42
Website
info@idromgroup.com
EUDAMED record
Report an error
Igluco Tech
Spain
IIa
MDR
Website
regulatory@glucube.com
EUDAMED record
Report an error
Imactis FDA
France
IIb
MDR
eudamed@gehealthcare.com
EUDAMED record
Report an error
Image Navigation FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
MDR
EUDAMED record
Report an error
Imedtech FDA
Netherlands
I
93/42
Website
info@i-Medtech.nl
EUDAMED record
Report an error
Immanecorp
EU representative : CS Active (Latvia)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Imp - Piezotehnologija Doo Beograd
EU representative : Salus Cons Kft. (Hungary)
Serbia
IIa
93/42
Website
info@magnetipupin.com
EUDAMED record
Report an error
Impeto Medical FDA
France
IIa
93/42
Website
regulatory@withings.com
EUDAMED record
Report an error
Implura
Germany
IIa
MDR, 93/42
Website
info@implura.com
EUDAMED record
Report an error
In Cas - Innovazioni Casamichele
Italy
I
MDR
Website
info@incasmed.com
EUDAMED record
Report an error
Infident
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
sales@infident.cn
EUDAMED record
Report an error
Infitek FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
InfraScan FDA
EU representative : QbD RepS BV (Belgium)
United States
IIa
MDR
Website
support@infrascanner.com
EUDAMED record
Report an error
Inogen FDA
EU representative : Inogen Europe B.V. (Netherlands)
United States
IIb
MDR
Website
Regulatory@inogen.net
EUDAMED record
Report an error
Inotec AMD FDA
EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland)
United Kingdom (ex Northern Ireland)
IIa, IIb
93/42
Website
support@natroxwoundcare.com
EUDAMED record
Report an error
Inovytec FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIb
MDR
Website
info@inovytec.com
EUDAMED record
Report an error
Inreda Diabetic
Netherlands
IIb
MDR
Website
eudamedinfo@inredadiabetic.nl
EUDAMED record
Report an error
Insera Therapeutics FDA
EU representative : MediMark Europe Sarl. (France)
United States
IIa
93/42
EUDAMED record
Report an error
Inspectis
Sweden
I
MDR
Website
info@inspect-is.com
EUDAMED record
Report an error
Institut Du Cerveau Et De La Moelle Epiniere
France
I
MDR
Website
EUDAMED record
Report an error
Intalight
EU representative : Eunitor GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Integra MicroFrance FDA
France
IIa
93/42
EUDAMED record
Report an error
Intelligent Hearing Systems FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
EUDAMED record
Report an error
intelligent motion
Austria
IIa
93/42
info@intelligentmotion.at
EUDAMED record
Report an error
International Biomedical FDA
Switzerland
IIb
MDR
Website
EUDAMED record
Report an error
Inti Taiwan
EU representative : Luana Med. B.V. (Netherlands)
Taiwan
I
MDR
Website
EUDAMED record
Report an error
Involutech
France
I
MDR
Website
hello@involutech.com
EUDAMED record
Report an error
Ionclinics
Spain
IIa
MDR
Website
info@ionclinics.com
EUDAMED record
Report an error
Ipeewell
Slovenia
I
MDR
Website
info@ipeewell.com
EUDAMED record
Report an error
IT Concepts FDA
Germany
I
MDR
Website
info@itcworld.com
EUDAMED record
Report an error
IT serve, s.r.o
Czechia
I
MDR
EUDAMED record
Report an error
Ivoclar FDA
Liechtenstein
I
MDR
Website
EUDAMED record
Report an error
Jafron
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
93/42
customerservice@jafron.com
EUDAMED record
Report an error
JAM-Labs FDA
EU representative : Obelis s.a. (Belgium)
United States
I
MDR
Website
EUDAMED record
Report an error
JeaMed Medical
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Jean Marie Lorenz FDA
Italy
IIa
93/42
Website
EUDAMED record
Report an error
Jiangsu Jinyuan Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Jiangsu Jumao X-Care Medical Equipment FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
Jiangsu Rooe Medical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Jiangsu Yahong Meditech
EU representative : Obelis s.a. (Belgium)
China
IIb
MDR
Website
EUDAMED record
Report an error
Jiangsu Yongle Medical Technology FDA
EU representative : Everbiz GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Jiangxi Securmed Medical Technology
EU representative : phoenix Medtech GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Jianlian Homecare Products FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
Website
EUDAMED record
Report an error
Jiaxing Zhitong Technology
EU representative : PureCE B.V. (Netherlands)
China
I
MDR
supports@ainnovi.com
EUDAMED record
Report an error
Jiedemedical FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Jindřich Bureš
Czechia
I
MDR
Website
EUDAMED record
Report an error
Jlb France
France
IIa
MDR
info@g5concept.com
EUDAMED record
Report an error
Jnbio
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
93/42
Website
info@ejnbio.com
EUDAMED record
Report an error
Johnson & Johnson Surgical Vision FDA
EU representative : AMO Ireland (Ireland)
United States
IIb
MDR
Website
RA-VISEU-DUVigilance@ITS.JNJ.com
EUDAMED record
Report an error
Joint Stock Ryazan State Instrument-Making Enterprise
EU representative : Tonom GmbH (Germany)
Russia
IIa
93/42
EUDAMED record
Report an error
Jolife FDA
Sweden
IIb
MDR
Website
info@lucas-cpr.com
EUDAMED record
Report an error
Jousing
EU representative : Wellkang Ltd (Northern Ireland)
China
III
MDR
EUDAMED record
Report an error
JPS FDA
EU representative : Obelis s.a. (Belgium)
Japan
I
MDR
Website
EUDAMED record
Report an error
Kaltek
Italy
I
MDR
info@kaltek.it
EUDAMED record
Report an error
Kaneka FDA
EU representative : Kaneka Medical Europe N.V. (Belgium)
Japan
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Kanekamedical FDA
Belgium
IIb
MDR
Website
contact@kaneka.de
EUDAMED record
Report an error
Kangjin FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
93/42
EUDAMED record
Report an error
Kaniedenta
Germany
I
MDR
eudamed@kaniedenta.productions
EUDAMED record
Report an error
Karaoğlu Baskül Ve Cerrahi̇ Aletler İmal San Ti̇c Şti̇
Türkiye
I
MDR
Website
info@karaoglucerrahi.com.tr
EUDAMED record
Report an error
Kardi
Czechia
IIa
MDR
Website
EUDAMED record
Report an error
Kci Usa FDA
EU representative : KCI Manufacturing Unlimited Company (Ireland)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Keelerusa
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Keensea
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Kenmak
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Kern & Sohn
Germany
I
MDR
EUDAMED record
Report an error
Kesinmedikal
Türkiye
IIb
93/42
Website
EUDAMED record
Report an error
Kico Knee Innovation Pty FDA
Australia
IIa
MDR
EUDAMED record
Report an error
Kilde &
Denmark
I
MDR
Website
EUDAMED record
Report an error
Kinexcs FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
Singapore
I
MDR
Website
info@kinexcs.com
EUDAMED record
Report an error
Klarity Medical & Equipment（GZ）
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
sales@klarity-medical.com
EUDAMED record
Report an error
Kluge & Fielitz
Germany
IIa
MDR
Website
info@kluge-fielitz.com
EUDAMED record
Report an error
KMS Medical Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Koalys
EU representative : AR Experts B.V. (Netherlands)
Israel
IIa
93/42
Website
contact@koalys.com
EUDAMED record
Report an error
Kodra
Germany
IIa
MDR
Website
eudamed@kodra.de
EUDAMED record
Report an error
Konanmedical FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Kriomedpol
Poland
IIa
93/42
Website
EUDAMED record
Report an error
L. Molteni & C. dei F.lli Alitti - Società di Esercizio -
Italy
IIa
MDR
Website
EUDAMED record
Report an error
L.M. Medical Division
Italy
IIb
MDR
Website
info@lmmedicaldivision.com
EUDAMED record
Report an error
Laftan Trading International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
info@laftansurgical.net
EUDAMED record
Report an error
Lagis FDA
EU representative : Obelis s.a. (Belgium)
Taiwan
IIa
MDR
Website
service@lagis.com.tw
EUDAMED record
Report an error
Lambda Health System
EU representative : Veranex Germany GmbH (Germany)
Switzerland
IIa
MDR
Website
info@lhs-sa.ch
EUDAMED record
Report an error
Lameditech FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
93/42
Website
sales@lameditech.com
EUDAMED record
Report an error
Larganmed FDA
EU representative : MDSS GmbH (Germany)
Taiwan
IIa
93/42
Website
EUDAMED record
Report an error
Lasering FDA
Italy
IIb
MDR
EUDAMED record
Report an error
Lbenergia
Poland
IIa
93/42
EUDAMED record
Report an error
LD Medicare
France
IIa
MDR
Website
Contact@ldmedicare.com
EUDAMED record
Report an error
Leaflife FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Leaseir FDA
Spain
IIb
93/42
Website
info@leaseir.com
EUDAMED record
Report an error
Leica Instruments (Singapore) Pte
EU representative : Leica Microsystems CMS GmbH (Germany)
Singapore
IIa
MDR
Website
EUDAMED record
Report an error
Leisegang
Germany
I
MDR
Website
EUDAMED record
Report an error
Lensar FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
MDR
Website
EUDAMED record
Report an error
Lev-EL Heart Diagnostics
EU representative : MedNet EC-REP GmbH (Germany)
Israel
IIa
93/42
Website
info@Levhm.com
EUDAMED record
Report an error
Lexion Medical FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
United States
IIa
93/42
Website
customerservice@lexionmedical.com
EUDAMED record
Report an error
Liaisonmed
EU representative : SUNGO Europe B.V. (Netherlands)
China
MN-OR001,MN-OR002,MN-OR003, MN-OR004，MN-OR004A,MN-OR004B, MN-OR005,MN-OR006,MN-OR007， MN-OR008,MN-OR009,MN-OR010, etc
I
MDR
EUDAMED record
Report an error
Lifedent
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
hello@lifedent.cn
EUDAMED record
Report an error
Lifescience-Robotics
Denmark
IIa
MDR
Website
info@lifescience-robotics.com
EUDAMED record
Report an error
Liger Medical FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
United States
I
MDR
Website
support@ligermedical.com
EUDAMED record
Report an error
LIME medical
Germany
IIa
MDR
info@lime-medical.de
EUDAMED record
Report an error
Limmer Laser
Germany
I
MDR
Website
eudamed@limmerlaser.de
EUDAMED record
Report an error
Lina Medical Aps FDA
Denmark
IIb
93/42
Website
EUDAMED record
Report an error
Linacolmedikal
Türkiye
IIa
93/42
Website
info@linacolmedikal.com
EUDAMED record
Report an error
Linktop
EU representative : Share info GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Lischka FDA
Germany
IIa
MDR, 93/42
Website
EUDAMED record
Report an error
LivsMed FDA
EU representative : Meridius Medical Europe Limited (Ireland)
South Korea
IIb
MDR
Website
info@livsmed.com
EUDAMED record
Report an error
Lmb
Germany
IIa
MDR
EUDAMED record
Report an error
LMT Medical Systems FDA
Germany
IIb
MDR
Website
info@lmt-medicalsystems.com
EUDAMED record
Report an error
Lockdown Medical FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
customerservice@lockdownsurgical.com
EUDAMED record
Report an error
Log10
Netherlands
IIb
MDR
Website
info@log-ten.com
EUDAMED record
Report an error
Lola&Lykke
Finland
I
MDR
Website
EUDAMED record
Report an error
LTRA Global FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIb
93/42
EUDAMED record
Report an error
Luckcome
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
info@luckcome.com
EUDAMED record
Report an error
Luminous Global
EU representative : be-on-market GmbH (Germany)
United States
I
MDR
EUDAMED record
Report an error
Lundair
Sweden
IIa
MDR
Website
info@lundair.com
EUDAMED record
Report an error
Lutech Industries FDA
EU representative : Arazy Group GmbH (Germany)
United States
I
MDR
Website
info@lutechmedical.com
EUDAMED record
Report an error
Luxiona
Poland
I
MDR
Website
EUDAMED record
Report an error
LymphaTouch FDA
Finland
IIa
93/42
contact@lymphatouch.com
EUDAMED record
Report an error
Lys Medical
Belgium
I
MDR
Website
info@lysmedical.com
EUDAMED record
Report an error
M Dialysis FDA
Sweden
IIa
MDR
Website
info@mdialysis.com
EUDAMED record
Report an error
M.A.S. Medical
Italy
IIa
MDR
Website
info@drainstar.it
EUDAMED record
Report an error
M.I.One FDA
EU representative : AF Pharma Service Europe SL (Spain)
South Korea
I
MDR
info@mione.co.kr
EUDAMED record
Report an error
Magnosco
Germany
I
MDR
Website
info@magnosco.com
EUDAMED record
Report an error
Maillefer Instruments Holding Sàrl
EU representative : Dentsply DeTrey GmbH (Germany)
Switzerland
I
MDR
EUDAMED record
Report an error
Maisindia
EU representative : Obelis s.a. (Belgium)
India
IIa
MDR
Website
qa@maisindia.in
EUDAMED record
Report an error
Maltron International
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
93/42
EUDAMED record
Report an error
Maokangmedical FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
MaRhyThe Systems
Germany
IIa
93/42
Website
info@marhythe-systems.de
EUDAMED record
Report an error
Mariotti & C
Italy
IIa
MDR
Website
info@mariotti-italy.com
EUDAMED record
Report an error
Materialise FDA
Belgium
I
MDR
info.motion@materialise.be
EUDAMED record
Report an error
Maunakeatech FDA
France
IIa
93/42
ra@maunakeatech.com
EUDAMED record
Report an error
Mazor Robotics FDA
EU representative : Medtronic B.V. (Netherlands)
Israel
I, IIb
MDR
EUDAMED record
Report an error
McRoberts FDA
Netherlands
I
MDR
Website
info@mcroberts.nl
EUDAMED record
Report an error
Mde Kft
Hungary
IIa
93/42
Website
info@mdegmbh.eu
EUDAMED record
Report an error
Mdh
Poland
I
MDR
Website
EUDAMED record
Report an error
Mdoloris FDA
France
IIa
MDR
Website
EUDAMED record
Report an error
Mdprod
France
I
MDR
EUDAMED record
Report an error
Meccomed
EU representative : Share info GmbH (Germany)
China
Curing Light i-cure, i-cure pro, i-cure corded, Q5, Q6, Q6 corded, Q7, Q8, Q8 Pro, Q9, TQ8, IQ8,Dolphin, Dolphin corded 3 refs
I
MDR
mailbox@meccomed.com
EUDAMED record
Report an error
MED FDA
Italy
IIb
93/42
EUDAMED record
Report an error
Med-Storm Innovation FDA
Norway
IIa
MDR
Website
support@med-storm.com
EUDAMED record
Report an error
MedArt
Denmark
IIb
93/42
Website
EUDAMED record
Report an error
Medartis FDA
EU representative : Medartis GmbH (Germany)
Switzerland
IIa
MDR
EUDAMED record
Report an error
Medbeat
Sweden
IIa
MDR
Website
contact@medbeat.se
EUDAMED record
Report an error
MedCare Visions
Germany
IIb
MDR
Website
info@mcv-group.de
EUDAMED record
Report an error
Meddrop
Germany
I
MDR
Website
info@meddrop.com
EUDAMED record
Report an error
Medeia FDA
Bulgaria
IIa
MDR
Website
info@medeia.com
EUDAMED record
Report an error
MEDEL Medizinische Elektronik Handelsgesellschaft mbH
Germany
IIa
MDR
Website
info@medel-hamburg.de
EUDAMED record
Report an error
Medequip FDA
EU representative : AF Pharma Service Europe SL (Spain)
India
I
MDR
EUDAMED record
Report an error
Medexa
Sweden
I
93/42
Website
info@medexa.se
EUDAMED record
Report an error
Medezine
EU representative : European Healthcare & Device Solutions Ltd. (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
sales@medezine.co.uk
EUDAMED record
Report an error
Medfruition FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Medhealth FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
MEDI CAL HealthCare
Germany
I
MDR
Website
mail@medi-cal.de
EUDAMED record
Report an error
MEDI help
Germany
I
MDR
Website
info@medi-help.de
EUDAMED record
Report an error
MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o
Slovenia
I
MDR
EUDAMED record
Report an error
Medical Devices Technology International
EU representative : MDTi Cyprus Ltd (Cyprus)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@mdti.co.uk
EUDAMED record
Report an error
Medicalgorithmics FDA
Poland
IIa
MDR
Website
regulatory@medicalgorithmics.com
EUDAMED record
Report an error
MedicalPark FDA
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
93/42
EUDAMED record
Report an error
Medicaroid
EU representative : Medicaroid Europe GmbH (Germany)
Japan
IIb
MDR
EUDAMED record
Report an error
Medicure
EU representative : Yellow's medical instruments GmbH (Germany)
Pakistan
I
MDR
Website
info@medicure.pk
EUDAMED record
Report an error
Mediderma
Spain
IIa
93/42
regulatory@sesderma.com
EUDAMED record
Report an error
Medihightec
EU representative : MDSS GmbH (Germany)
Taiwan
IIa
93/42
Website
sales@medihightec.com
EUDAMED record
Report an error
Medikal Olusum Sanayi Ve Ticaret Sirketi
Türkiye
A
IVDR
Website
info@moslab.com
EUDAMED record
Report an error
Medinice FDA
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Medipia-Laa
EU representative : AR Experts B.V. (Netherlands)
South Korea
I
MDR
EUDAMED record
Report an error
Medipo
Czechia
I
MDR
Website
info@medipo.cz
EUDAMED record
Report an error
Medisport
Italy
IIa
MDR
Website
info@medisport.it
EUDAMED record
Report an error
Medist
Slovakia
IIa
MDR
Website
EUDAMED record
Report an error
Meditech Endoscopy FDA
EU representative : Elara Pharmaservices Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@i-medical.net
EUDAMED record
Report an error
Medizintechnik FDA
Germany
I, IIa
MDR, 93/42
Website
info@AS-Medizintechnik.de
EUDAMED record
Report an error
Medizintechnik Behounek
Austria
IIa
MDR
Website
EUDAMED record
Report an error
Medke FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Medkon
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
MEDKONSULT medical technology s.r.o FDA
Czechia
IIa
MDR
Website
regulatory@mmtsystems.com
EUDAMED record
Report an error
Medlander FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Medmix FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIa
93/42
Website
sales@medmix.co.kr
EUDAMED record
Report an error
Medmont FDA
EU representative : PureCon bvba (Belgium)
Australia
IIa
MDR
EUDAMED record
Report an error
Mednosbro FDA
EU representative : Axxos GmbH (Germany)
Switzerland
I
MDR
Website
info@mednosbro.ch
EUDAMED record
Report an error
Medpulses
EU representative : MicroPort Medical B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
MedSniper FDA
Italy
I
MDR
Website
EUDAMED record
Report an error
Medsure Medical Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Medtron
Germany
IIb
MDR
Website
info@medtron.com
EUDAMED record
Report an error
Medtrust
Austria
IIa
93/42
Website
EUDAMED record
Report an error
Megadyne Medical Products FDA
EU representative : Johnson & Johnson Medical GmbH (Germany)
United States
IIb
MDR
eudamed_enquiries@its.jnj.com
EUDAMED record
Report an error
MegaGen Implant FDA
EU representative : MDSS GmbH (Germany)
South Korea
IIa
MDR
EUDAMED record
Report an error
Meloq FDA
Sweden
I
MDR
Website
info@meloq.se
EUDAMED record
Report an error
Memmert
Germany
I
MDR
Website
info@memmert.com
EUDAMED record
Report an error
Mercurymed FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Mericonn FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Mesa Ideas
Italy
I
MDR
Website
info@mesaideas.com
EUDAMED record
Report an error
Mesurons
France
IIa
MDR
contact@mesurons.com
EUDAMED record
Report an error
Metaphysis LLP
EU representative : Metaphysis (Ireland) Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@io-uk.com
EUDAMED record
Report an error
Metech International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
EUDAMED record
Report an error
Meteda
Italy
IIa
MDR
Website
info@meteda.it
EUDAMED record
Report an error
metek Medizin Technik Komponenten
Germany
IIb
MDR, 93/42
EUDAMED record
Report an error
Metran
EU representative : CMC Medical Devices & Drugs SL (Spain)
Japan
IIb
MDR
Website
support_en@metran.co.jp
EUDAMED record
Report an error
metrovision FDA
France
IIa
MDR
Website
contact@metrovision.com
EUDAMED record
Report an error
Mflabmedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
mHealth Technologies
Italy
I
MDR
Website
EUDAMED record
Report an error
Micomme
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
service@micommed.com
EUDAMED record
Report an error
Micon
Germany
IIb
93/42
info@micon.info
EUDAMED record
Report an error
Micrelmed
Greece
IIb
93/42
Website
info@micrelmed.com
EUDAMED record
Report an error
Micro Current Technology FDA
EU representative : BEXPERTISE SOLUTIONS, S.L. (Spain)
United States
IIa
MDR
EUDAMED record
Report an error
Micro-Energy Medical Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
MicroCube FDA
EU representative : MPS Medical Product Service GmbH (Germany)
United States
IIb
93/42
EUDAMED record
Report an error
Microgate
Italy
I
MDR
Website
info@microgate.it
EUDAMED record
Report an error
Micromar FDA
EU representative : Emergo Europe B.V. (Netherlands)
Brazil
IIa
MDR
Website
EUDAMED record
Report an error
MicroPAD
Italy
I
MDR
Website
info@micropad.it
EUDAMED record
Report an error
Mida Technology
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
I
MDR
EUDAMED record
Report an error
Miele FDA
Germany
IIb
MDR
Website
info@miele.de
EUDAMED record
Report an error
Mikrocerrahialetler
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Millturn
Sweden
IIb
MDR
Website
order@millturn.se
EUDAMED record
Report an error
Minam Optics
EU representative : AR Experts B.V. (Netherlands)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Mindmore
Sweden
IIa
MDR
Website
info@mindmore.com
EUDAMED record
Report an error
Minel
Hungary
I
MDR
Website
EUDAMED record
Report an error
Minze FDA
Belgium
I
MDR
Website
info@minzehealth.com
EUDAMED record
Report an error
Mirtlemed
EU representative : MedR-AR Services B.V. (Netherlands)
United States
IIb
93/42
Website
info@mirtlemed.com
EUDAMED record
Report an error
Mizuho Orthopedic Systems FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
MJW International
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
93/42
EUDAMED record
Report an error
MLase
Germany
IIb
MDR
Website
info@mlase.com
EUDAMED record
Report an error
Mnt Tıbbi Malzemeler San Tic Şti
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Mobercas
Spain
I
MDR
Website
administracion@mobercas.com
EUDAMED record
Report an error
Mobiendos
Spain
I
MDR
Website
administracion@mobi-endos.com
EUDAMED record
Report an error
Modulight FDA
Finland
IIb
93/42
Website
info@modulight.com
EUDAMED record
Report an error
Modus Health FDA
EU representative : Advena Limited (Malta)
United States
I
MDR
Website
quality@modushealth.com
EUDAMED record
Report an error
Moeck & Moeck
Germany
IIb
MDR
EUDAMED record
Report an error
Monivent
Sweden
IIa
93/42
Website
info@monivent.se
EUDAMED record
Report an error
Moon Surgical FDA
EU representative : Moon Surgical SAS (France)
United States
I
MDR
Website
info@moonsurgical.com
EUDAMED record
Report an error
Morelli FDA
EU representative : Nuno Flores (Portugal)
Brazil
I
MDR
Website
regulatory@morelli.com.br
EUDAMED record
Report an error
Morettispa
Italy
I
MDR
Website
info@morettispa.com
EUDAMED record
Report an error
MS Westfalia
Germany
IIb
MDR
EUDAMED record
Report an error
Mtrplus
Germany
IIa
MDR
Website
info@mtrplus.com
EUDAMED record
Report an error
MuDanJiang Plasma Physical Application Technology
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
Website
Export_2@bjderun.com
EUDAMED record
Report an error
My Implant Business FDA
Germany
IIa
MDR
info@myimplantbusiness.com
EUDAMED record
Report an error
mylife Diabetes Care
EU representative : mylife Distribution GmbH (Germany)
Switzerland
IIb
MDR
regulatory-affairs@mylife-diabetescare.com
EUDAMED record
Report an error
Nanjing Kangju Medical Instrument
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Nanjing Ludao Medical Technology
EU representative : Everbiz GmbH (Germany)
China
operating lamp LD-Z200-12A, LD-Z200-12B, LD-Z200-12C, LD-Z300-24A, LD-Z300-24B, LD-Z300-24C, LD-Z400-36A, LD-Z400-36B, LD-Z400-36C, LD-Z500-48A, LD-Z500-48B, LD-Z500-48C.
I
MDR
EUDAMED record
Report an error
Nantong Unicorn Medical Electronics
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Narula Exports
EU representative : EUmAccess GmbH (Germany)
India
I
MDR
EUDAMED record
Report an error
Nddmed FDA
EU representative : NDD Medizintechnik GmbH (Germany)
Switzerland
IIa
MDR
Website
support@ndd.ch
EUDAMED record
Report an error
Needle Concept
France
IIa
93/42
Website
contact@needleconcept.com
EUDAMED record
Report an error
Neteera FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
IIa
MDR
Website
info@neteera.com
EUDAMED record
Report an error
Neuranix
Italy
IIa
MDR
Website
info@neuranix.com
EUDAMED record
Report an error
Neuro Event Labs FDA
Finland
I
93/42
Website
contact@neuroeventlabs.com
EUDAMED record
Report an error
Neurobittech FDA
EU representative : KOMAS Medical Technology GmbH (Germany)
Taiwan
I
MDR
info@neurobittech.com
EUDAMED record
Report an error
Neurolief FDA
EU representative : MDSS GmbH (Germany)
Israel
IIa
MDR
Website
EUDAMED record
Report an error
Neuromedex FDA
Germany
III
MDR
Website
contact@neuromedex.com
EUDAMED record
Report an error
Neurostimulation Medtech FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
IIa
MDR
Website
EUDAMED record
Report an error
Neurosynaptic
EU representative : Amstermed B.V. (Netherlands)
India
IIa
93/42
Website
info@neurosynaptic.com
EUDAMED record
Report an error
Neurotronics FDA
EU representative : NIHON KOHDEN EUROPE GmbH (Germany)
United States
IIa
93/42
Website
quality@neurotronics.com
EUDAMED record
Report an error
Neurovisionmedical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
EUDAMED record
Report an error
Neuwave FDA
EU representative : Johnson & Johnson Medical GmbH (Germany)
United States
IIb
MDR
EUDAMED record
Report an error
New Idem
Italy
IIa
MDR
Website
info@idemriuniti.it
EUDAMED record
Report an error
New Medical Technologies FDA
EU representative : United Medical Partners B.V. (Netherlands)
Switzerland
IIa
93/42
Website
EUDAMED record
Report an error
New NI Medical (2011)
EU representative : CEpartner4U (Netherlands)
Israel
IIa
93/42
EUDAMED record
Report an error
New Wellness Concept FDA
Spain
I
MDR
EUDAMED record
Report an error
newbox medical FDA
Germany
IIa
MDR
Website
service@newbox-medical.com
EUDAMED record
Report an error
Newconceptmed
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
I
MDR
Website
EUDAMED record
Report an error
Newmanbrain
Spain
IIa
MDR
Website
contact@newmanbrain.com
EUDAMED record
Report an error
Newmedsrl
Italy
IIb
MDR
Website
EUDAMED record
Report an error
Newpong FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIb
93/42
info@newpong.com
EUDAMED record
Report an error
NEXACorteX s.r.o
Czechia
I
MDR
Website
info@optosense.cz
EUDAMED record
Report an error
Nihon Seimitsu Sokki FDA
EU representative : MDSS GmbH (Germany)
Japan
IIa
MDR
Website
info@nissei-kk.co.jp
EUDAMED record
Report an error
Ningbo Haishu Yeson Medical Device
EU representative : MedPath GmbH (Germany)
China
IIb
93/42
quality@yeson-medicine.com
EUDAMED record
Report an error
Ningbo Handrescue Imp. & Exp
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Ningbo Healthway Import & Export
EU representative : HyperCert Limited B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Ningbo Hitcm Medical Devices
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Ningbo Jianeng Medical Equipment
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Ningbo Medsonz Medical Instrument
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
Website
EUDAMED record
Report an error
Ningbo Pinmed Instruments
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Ningbo Ranor Medical Science & Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
ranor1@chinaranor.com
EUDAMED record
Report an error
Ningbo Zhuoqiu Medical Equipment FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Nipro Pure Water
Germany
IIb
MDR
EUDAMED record
Report an error
NM Stahlgeräte
Germany
IIa
MDR
Website
info@nm-stahlgeraete.com
EUDAMED record
Report an error
Nonuple Medtec
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
info@wastonmed.com
EUDAMED record
Report an error
Noraxon FDA
EU representative : Advena Limited (Malta)
United States
I
MDR
Website
EUDAMED record
Report an error
Nordic-NeuroSTIM
Denmark
I
MDR
Website
info@nordicneurostim.com
EUDAMED record
Report an error
North Coast Medical FDA
EU representative : ICON (LR) Limited (Ireland)
United States
I
MDR
Website
quality@ncmedical.com
EUDAMED record
Report an error
Nortion
EU representative : phoenix Medtech GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Noruco
Spain
IIa
93/42
Website
info@noruco.com
EUDAMED record
Report an error
NOVAK M proizvodnja, trgovina in storitve d.o.o
Slovenia
I
MDR
Website
info@novak-m.si
EUDAMED record
Report an error
NovaSight FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
IIa
MDR
Website
EUDAMED record
Report an error
Novatech FDA
France
IIa
MDR
vigilance@novatech.fr
EUDAMED record
Report an error
Novo Klinik-Service
Germany
I
MDR
Website
info@novo-med.de
EUDAMED record
Report an error
NOxBOX FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIb
93/42
EUDAMED record
Report an error
NSON FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Nuga Medical FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Nuovotherapy
Slovakia
I
MDR
Website
info@nuovotherapy.cz
EUDAMED record
Report an error
Nuoyuanmedical
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Nuraleve
EU representative : Obelis s.a. (Belgium)
Canada
IIa
MDR
Website
regulatory.affairs@nuraleve.com
EUDAMED record
Report an error
O2 Concepts FDA
EU representative : MED IVD HEALTHTECH (Spain)
United States
IIb
MDR
Website
info@o2-concepts.com
EUDAMED record
Report an error
OBS Medical FDA
EU representative : AF Pharma Service Europe SL (Spain)
United Kingdom (ex Northern Ireland)
IIa
93/42
EUDAMED record
Report an error
Od-Os FDA
Germany
IIb
MDR
Website
info@od-os.com
EUDAMED record
Report an error
Offhealth
Italy
IIa
93/42
Website
info@offhealth.it
EUDAMED record
Report an error
Officine Ortopediche Rizzoli
Italy
I
93/42
Website
info@officinerizzoli.it
EUDAMED record
Report an error
Okuvision
Germany
IIa
MDR
Website
info@okuvision.de
EUDAMED record
Report an error
Onera FDA
Netherlands
IIa
93/42
Website
info@onerahealth.com
EUDAMED record
Report an error
Onnamed
France
IIa
MDR
Website
contact@onnamed.fr
EUDAMED record
Report an error
OOley Care
EU representative : Lotus NL B.V. (Netherlands)
Hong Kong SAR China
I
MDR
info@ooleycare.com
EUDAMED record
Report an error
Oomi
EU representative : Iyashi Dôme (France)
Switzerland
I
93/42
Website
EUDAMED record
Report an error
OOO NPF "Rehabilitation technologies"
EU representative : CEpartner4U (Netherlands)
Russia
I
MDR
Website
info@madin.ru
EUDAMED record
Report an error
OPED FDA
Germany
IIa
MDR
info@oped.de
EUDAMED record
Report an error
Opiatech FDA
France
IIa
MDR
contact@opiatech.com
EUDAMED record
Report an error
Orfit FDA
Belgium
I
MDR
Website
EUDAMED record
Report an error
OrganOx FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
regulatory@organox.com
EUDAMED record
Report an error
Orodeka FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
Website
info@orodeka.com
EUDAMED record
Report an error
Orthoheal FDA
EU representative : AF Pharma Service Europe SL (Spain)
India
I
MDR
Website
contact@orthoheal.com
EUDAMED record
Report an error
Ortivus
Sweden
IIb
MDR
info@ortivus.com
EUDAMED record
Report an error
Ortopedinen Osteopaatti T.Rantala ky
Finland
I
MDR
EUDAMED record
Report an error
Oruba
Türkiye
IIa
MDR
Website
info@oruba.com.tr
EUDAMED record
Report an error
Oryamedikal
Türkiye
IIb
MDR
Website
info@oryamedikal.com.tr
EUDAMED record
Report an error
Osatu Sociedad Cooperativa
Spain
III
MDR
Website
EUDAMED record
Report an error
Oscilla FDA
Denmark
IIa
MDR
Website
info@oscilla.dk
EUDAMED record
Report an error
Oscimedsa FDA
EU representative : OSCIMED EUROPE SAS (France)
Switzerland
I
MDR
Website
info@oscimedsa.com
EUDAMED record
Report an error
Oska FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
regulatory@oskawellness.com
EUDAMED record
Report an error
Osteonic FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIa
93/42
EUDAMED record
Report an error
Osypkamed FDA
Germany
IIa
93/42
Website
mail@osypkamed.com
EUDAMED record
Report an error
Otech Industry
Italy
IIb
93/42
Website
info@otechindustry.it
EUDAMED record
Report an error
Otivio
Norway
IIa
MDR
Website
info@otivio.com
EUDAMED record
Report an error
Otwo FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Canada
IIb
93/42
Website
regulatory@otwo.com
EUDAMED record
Report an error
Owen Mumford FDA
EU representative : Owen Mumford GmbH (Germany)
United Kingdom (ex Northern Ireland)
I
MDR
info@owenmumford.com
EUDAMED record
Report an error
Oxavita FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Argentina
IIb
93/42
Website
EUDAMED record
Report an error
OXUS FDA
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIb
93/42
EUDAMED record
Report an error
Oxybarica
Spain
IIb
MDR
Website
info@oxybarica.com
EUDAMED record
Report an error
OxyPrem
EU representative : EUSwissMed GmbH (Germany)
Switzerland
IIa
MDR
Website
info@oxyprem.com
EUDAMED record
Report an error
Oxyvix
Italy
I
MDR
EUDAMED record
Report an error
Papanikolaou Christos & Sia Ee
Greece
IIa
MDR
info@optohellas.com
EUDAMED record
Report an error
PAR Medizintechnik FDA
Germany
IIa
MDR
Website
info@par-berlin.com
EUDAMED record
Report an error
Paragon 28 FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Partners for Endoscopy
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Pascal FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Pereg
Germany
I
MDR
info@pereg.de
EUDAMED record
Report an error
Perfection Plus
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Periso
EU representative : Studio Murgia Srl (Italy)
Switzerland
IIa
93/42
EUDAMED record
Report an error
Phlecs
Netherlands
IIa
93/42
Website
EUDAMED record
Report an error
Phoenix Innovative Healthcare Manufacturers FDA
EU representative : Advena Limited (Malta)
India
I
MDR
EUDAMED record
Report an error
Photonic
Austria
I
MDR
office@photonic.at
EUDAMED record
Report an error
Physidia
France
IIb
93/42
Website
EUDAMED record
Report an error
Physio Börse
Germany
I
MDR
info@physio-boerse.de
EUDAMED record
Report an error
PhysioSign Hong Kong Medical
EU representative : Everbiz GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Pilot Blankenfelde Medizinisch-Elektronische Geräte
Germany
IIa
93/42
Website
admin@pilot-blankenfelde.de
EUDAMED record
Report an error
Pixience
France
I
MDR
Website
contact@pixience.com
EUDAMED record
Report an error
Plasmacure
Netherlands
IIb
93/42
Website
EUDAMED record
Report an error
Pneumed
Germany
IIa
93/42
Website
info@pneumed.de
EUDAMED record
Report an error
Pointpressure
Italy
I
MDR
EUDAMED record
Report an error
Policardio
Italy
IIa
93/42
Website
support@policardio.com
EUDAMED record
Report an error
Polymorit
EU representative : Eurolink Europe Compliance Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
sales@polymorit.com
EUDAMED record
Report an error
Power On Medical
EU representative : GRZAN GROUP SL (Spain)
China
I
MDR
EUDAMED record
Report an error
PPRS
France
IIa
MDR
Website
contact@pprs-research.com
EUDAMED record
Report an error
Pragmat
Canada
IIa
MDR
Website
info@pragmat.ca
EUDAMED record
Report an error
Praxis Medical Network
Italy
I
MDR
Website
info@praxismedicalnetwork.com
EUDAMED record
Report an error
Precision Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Premierguard FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
EUDAMED record
Report an error
Premis
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Premium Plus (Dongguan)
EU representative : Premium Plus Poland sp. z o.o. (Poland)
China
I
MDR
info@premiumpluschina.com
EUDAMED record
Report an error
Prilanta Surgical
EU representative : ANTEX MEDI SOLUTION (Germany)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Prime Dental Manufacturing FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
I
MDR
Website
qa@primedentalmfg.com
EUDAMED record
Report an error
Primedic(Jiangsu) Medical Technology
EU representative : Metrax GmbH (Germany)
China
III
MDR
EUDAMED record
Report an error
Prizma
EU representative : Prizma GmbH (Germany)
Serbia
IIb
MDR
Website
sales@prizma.rs
EUDAMED record
Report an error
Promeba
Spain
I
MDR
Website
EUDAMED record
Report an error
Promepla FDA
EU representative : Promepla Group S.à r.l. (Luxembourg)
Monaco
IIa
MDR
Website
contact@promepla.com
EUDAMED record
Report an error
Promisemed FDA
EU representative : Obelis s.a. (Belgium)
China
IIa
MDR
EUDAMED record
Report an error
Prosperity Biotech (Shandong)
EU representative : EUREP ENV, S.L (Spain)
China
I
MDR
EUDAMED record
Report an error
Prunusmedical FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIb
MDR
Website
EUDAMED record
Report an error
Pulnovomed
EU representative : BioDomi GmbH (Germany)
China
IIb
MDR
ra@pulnovomed.com
EUDAMED record
Report an error
Qinhuangdao Kapunuomaite Medical Equipment S&T FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
Website
info@capnomed.cn
EUDAMED record
Report an error
Qolight FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
QT Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
United States
IIa
93/42
Website
marketing@qtmedical.com
EUDAMED record
Report an error
Quantum Surgical FDA
France
IIa
MDR
Website
EUDAMED record
Report an error
QuinTron Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
A
IVDR
Website
regulatory@quintron-usa.com
EUDAMED record
Report an error
Quirosa
Spain
I
MDR
Website
info@quirosa.com
EUDAMED record
Report an error
Qviti
Poland
IIa
93/42
Website
EUDAMED record
Report an error
Radiometer FDA
Denmark
IIb
MDR
Website
radiometerra_eu@radiometer.dk
EUDAMED record
Report an error
RAM
Italy
I
MDR
EUDAMED record
Report an error
Rand FDA
Italy
IIb
MDR
Website
info@rand-biotech.com
EUDAMED record
Report an error
RDT
Austria
IIa
93/42
office@g-z-i.at
EUDAMED record
Report an error
Reachsurgical FDA
EU representative : MDSS GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Rebornendo FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
Website
Sales4@rebornendo.com
EUDAMED record
Report an error
Rebstock FDA
Germany
I
MDR
Website
info@rebstock.de
EUDAMED record
Report an error
Recbioengineering
Italy
I
MDR
Website
EUDAMED record
Report an error
Redax FDA
Italy
IIa
MDR
EUDAMED record
Report an error
RedDress FDA
EU representative : AR Experts B.V. (Netherlands)
Israel
IIa
93/42
EUDAMED record
Report an error
Reha-Stim Medtec FDA
Germany
IIa
MDR
Website
EUDAMED record
Report an error
Rehab-Robotics FDA
EU representative : MedNet EC-REP GmbH (Germany)
Hong Kong SAR China
IIa
MDR
Website
EUDAMED record
Report an error
Rehamedi
Germany
I
MDR
Website
info@rehamedi.de
EUDAMED record
Report an error
Rehawash
Netherlands
IIa
MDR
Website
info@rehawash.com
EUDAMED record
Report an error
Reiner
Spain
I
MDR
EUDAMED record
Report an error
Relegs
Netherlands
IIa
93/42
Website
support@relegs.com
EUDAMED record
Report an error
Remidio
EU representative : mdi Europa GmbH (Germany)
India
I
MDR
Website
EUDAMED record
Report an error
Renew Group FDA
EU representative : Renew Health Ltd. (Ireland)
Singapore
IIa
MDR
Website
contactus@renewgpl.com
EUDAMED record
Report an error
Renishaw Mayfield FDA
France
IIb
MDR
EUDAMED record
Report an error
Resla
Germany
I
MDR
EUDAMED record
Report an error
Respomed
EU representative : Ruiyi Healthcare GmbH (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
Rexuma
Sweden
IIa
93/42
Website
info@rexuma.se
EUDAMED record
Report an error
Reyedar
Netherlands
I
MDR
Website
info@reyedar.com
EUDAMED record
Report an error
Rhythmlink FDA
EU representative : mdi Europa GmbH (Germany)
United States
IIa
MDR
Website
quality@rhythmlink.com
EUDAMED record
Report an error
Rimec
Italy
I
MDR
Website
EUDAMED record
Report an error
Rimsa FDA
Italy
I
MDR
Website
info@rimsa.it
EUDAMED record
Report an error
Rini FDA
Sweden
I
MDR
Website
info@rini.se
EUDAMED record
Report an error
Ripisrl
Italy
I
MDR
info@ripisrl.it
EUDAMED record
Report an error
Rk Innov
France
IIa
MDR
contact@rkinnov.fr
EUDAMED record
Report an error
Robsurgical
Spain
IIb
MDR
Website
regulatory@robsurgical.com
EUDAMED record
Report an error
Rokit Healthcare FDA
EU representative : AR Experts B.V. (Netherlands)
South Korea
I
MDR
Website
qa@rokit.co.kr
EUDAMED record
Report an error
Rokána Kft
Hungary
I
MDR
EUDAMED record
Report an error
Romsons FDA
EU representative : Obelis s.a. (Belgium)
India
IIa
MDR
Website
qa.ri@romsons.com
EUDAMED record
Report an error
Rooti Labs FDA
EU representative : Obelis s.a. (Belgium)
Taiwan
IIa
MDR
eudamed@rootilabs.com
EUDAMED record
Report an error
Rossiello Angelo
Italy
IIa
93/42
info@evolutamente.it
EUDAMED record
Report an error
Rrr Manufacturing Pty
EU representative : mdi Europa GmbH (Germany)
Australia
IIb
93/42
Website
EUDAMED record
Report an error
Ruichengmedical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
info@ruichengmedical.com
EUDAMED record
Report an error
Ruijinmedical FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
I
MDR
Website
info@whruijin.com
EUDAMED record
Report an error
S.I.M.E.O.N. Medical FDA
Germany
I
MDR
Website
regulatory@simeonmedical.com
EUDAMED record
Report an error
S2M
Sweden
IIa
93/42
Website
hello@s2m.se
EUDAMED record
Report an error
Sabora
Finland
I
93/42
Website
info@sabora.fi
EUDAMED record
Report an error
Sahilsurgical
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
Website
EUDAMED record
Report an error
Sairex
Finland
I
MDR
Website
EUDAMED record
Report an error
Salter Labs FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
I
MDR
Website
EUDAMED record
Report an error
Samsun Cerrahi̇ Aletler Sanayi̇ Ve Ti̇caret Şi̇rketi̇
Türkiye
I
MDR
Website
info@sca.com.tr
EUDAMED record
Report an error
Sanctuaryhealth FDA
EU representative : Wellkang Ltd (Northern Ireland)
Malaysia
I
MDR
Website
info@sanctuaryhealth.com.my
EUDAMED record
Report an error
Santa Barbara Imaging Systems FDA
EU representative : Qualrep Services B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Santec FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
IIa
MDR
Website
EUDAMED record
Report an error
Sapi Med FDA
Italy
I
MDR
Website
EUDAMED record
Report an error
Sasan
Türkiye
IIa
93/42
Website
EUDAMED record
Report an error
Satisform
France
I
MDR
Website
admin@satisform.com
EUDAMED record
Report an error
Sbsystem
Italy
I
MDR
info@sbsystem.it
EUDAMED record
Report an error
Sc Medica FDA
France
I
MDR
info@sc-medica.com
EUDAMED record
Report an error
SCHWIND eye-tech-solutions
Germany
IIb
MDR
info@eye-tech.net
EUDAMED record
Report an error
Schyns
Germany
IIb
MDR
Website
info@schyns.de
EUDAMED record
Report an error
Scibase FDA
Sweden
IIa
MDR
Website
info@scibase.com
EUDAMED record
Report an error
Scihealth
Lithuania
IIa
MDR
EUDAMED record
Report an error
Seawon Meditech FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIb
93/42
EUDAMED record
Report an error
Sense4Care
Spain
IIa
MDR
Website
info@sense4care.com
EUDAMED record
Report an error
Sensocure
Norway
IIa
MDR
Website
info@sensocure.no
EUDAMED record
Report an error
Sensodetect
Sweden
IIa
MDR
Website
info@sensodetect.com
EUDAMED record
Report an error
Sensorendo FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Sentechfrance
France
I
MDR
Website
EUDAMED record
Report an error
Sewoon Medical FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Sfsolutions
Poland
I
MDR
Website
EUDAMED record
Report an error
Shahab Surgical Industries
EU representative : International Business Compendious of Sweden (Sweden)
Pakistan
I
MDR
Website
info@shahabsi.com
EUDAMED record
Report an error
Shandong Lovego Industrial
EU representative : Kyslík pro život, s.r.o. (Czechia)
China
IIb
MDR
Website
EUDAMED record
Report an error
shandong pingan yongtai medical equipment
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shanghai Endofriend Medical Instruments
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Shanghai EndoView Medical
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
sales@outai.com
EUDAMED record
Report an error
Shanghai MAaGI Medical Technology
EU representative : Emergo Europe B.V. (Netherlands)
China
IIb
MDR
Website
office@magic-med.cn
EUDAMED record
Report an error
Shanghai NCC Electronic
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIb
MDR
EUDAMED record
Report an error
Shapemem FDA
EU representative : MedR-AR Services B.V. (Netherlands)
United States
IIa
93/42
info@shapemem.com
EUDAMED record
Report an error
Sharkninja FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
EUDAMED record
Report an error
Sheffmed FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Shenzhen Balinda Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
info@bld-pc.com
EUDAMED record
Report an error
Shenzhen Caremed Medical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shenzhen Changke Connect Electronics FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
Website
EUDAMED record
Report an error
Shenzhen Delica Medical Equipment FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
93/42
quality@delicasz.com
EUDAMED record
Report an error
Shenzhen Fitconn Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
Website
sales@cnfure.com
EUDAMED record
Report an error
Shenzhen GSD Tech FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen Hopfat Medical Instrument
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Shenzhen Marge Technology Sharing
EU representative : GRZAN GROUP SL (Spain)
China
I
MDR
EUDAMED record
Report an error
Shenzhen Minder Biomedical Tech
EU representative : SUNGO Europe B.V. (Netherlands)
China
N1001,N1002,N1003,N1004,N1005,N1006,N2001,N2002,N2003,N2004, N2005,N2006,N3001,N3002,N3003,N3004,N3005,N3006,N3007,N4001, N4002, N4003, N4004,N4005,N4006,N4007,N9001, N5001,N5002, etc 3 refs
I
MDR
EUDAMED record
Report an error
Shenzhen Narig Bio-Medical Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen OSTO Medical Technology FDA
EU representative : phoenix Medtech GmbH (Germany)
China
IIa
MDR
Website
sales06@szosto.com
EUDAMED record
Report an error
Shenzhen Pango Medical Electronics FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Shenzhen Perfect Medical Instruments FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Shenzhen Root Innovation Technology FDA
EU representative : Share info GmbH (Germany)
China
IIa
MDR
support@momcozy.com
EUDAMED record
Report an error
Shenzhen Sanping Imaging Technology
EU representative : Eunitor GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Shenzhen Shinuoqi Electronical Science Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shenzhen Tianjiquan Health Science & Technology Group
EU representative : BioDomi GmbH (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
Shenzhen Yuezhongxing Technology FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Shenzhen Yunze Medical Technology
EU representative : Kingsmead Service B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Shunmei Medical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
SIA "LINLINE Medical Systems"
Latvia
IIb
93/42
EUDAMED record
Report an error
Sichuan Bomesin Dental Equipment
EU representative : Llins Service & Consulting GmbH (Germany)
China
Dental Unit E200A, E200B, E200C, E200D, E200E, E200F, E200G, E200H, E200I, E200J, E200K, E200L, S500A, S500B, S500C, S500D, S500E, S500F 3 refs
IIa
MDR
EUDAMED record
Report an error
Siem Biomedicale
France
IIa
93/42
Website
info@siem-biomedicale.com
EUDAMED record
Report an error
Sigmadental
Germany
I
MDR
Website
EUDAMED record
Report an error
Silkn FDA
Netherlands
IIa
93/42
EUDAMED record
Report an error
Simad
Italy
I
MDR
Website
info@simad.net
EUDAMED record
Report an error
Simple & Smart
Italy
IIa
MDR
Website
info@simplesmart.it
EUDAMED record
Report an error
Sina Hamd Aria
EU representative : S.C PERDAC GLOBAL S.R.L (Romania)
Iran
IIb
MDR
Website
export3@sinabed.com
EUDAMED record
Report an error
Sincoheren FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Sinfomed
Germany
I
MDR
Website
EUDAMED record
Report an error
Skinuvita
Germany
IIa
MDR
info@skinuvita.de
EUDAMED record
Report an error
Sleepinnov
France
IIa
93/42
Website
contact@sleepinnov.com
EUDAMED record
Report an error
Sleepiz FDA
EU representative : MED-RAS GmbH Regulatory Affairs Service (Germany)
Switzerland
IIa
MDR
Website
info@sleepiz.com
EUDAMED record
Report an error
Smart Respiratory Products
EU representative : Smart Respiratory Manufacturing Kft. (Hungary)
United Kingdom (ex Northern Ireland)
IIa
93/42
info@smartasthma.com
EUDAMED record
Report an error
Smarthen
Spain
IIa
MDR
Website
info@smarthen.com
EUDAMED record
Report an error
smartQare
Netherlands
IIa
MDR
Website
EUDAMED record
Report an error
Smisson-Cartledge Biomedical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa, IIb
MDR
EUDAMED record
Report an error
Smith & Nephew FDA
EU representative : Smith & Nephew Operations BV (Netherlands)
United States
IIa
MDR
Website
eudamed-actor.global@smith-nephew.com
EUDAMED record
Report an error
Smsmed Medikal Imalat Sanayi Ticaret Sirketi
Türkiye
I
MDR
Website
info@smsmedikal.com.tr
EUDAMED record
Report an error
Sofwave FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
93/42
Website
support@sofwave.com
EUDAMED record
Report an error
Solsius
France
I
MDR
admin@solsius.fr
EUDAMED record
Report an error
Solventum FDA
Germany
I
MDR
info-medical-eu@solventum.com
EUDAMED record
Report an error
Somno Engineering
France
IIa
MDR
Website
EUDAMED record
Report an error
Specore Med-Tech
EU representative : Share info GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Spes Medica FDA
Italy
I
MDR
Website
info@spesmedica.com
EUDAMED record
Report an error
Spinafx
EU representative : AR Experts B.V. (Netherlands)
Canada
I
MDR
Website
info@spinafx.com
EUDAMED record
Report an error
Spring Health Products FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United States
I
MDR
Website
customercare@springhealthproducts.com
EUDAMED record
Report an error
Star Sports Medicine FDA
EU representative : Caretechion GmbH (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
Stendo
France
IIa
MDR
contact@stendo.net
EUDAMED record
Report an error
STIMVIA s.r.o
Czechia
IIa
MDR
EUDAMED record
Report an error
Stolmik
Poland
I
MDR
Website
EUDAMED record
Report an error
Stratec Medizintechnik FDA
Germany
I
MDR
info@stratec-med.com
EUDAMED record
Report an error
Streamcheck
Germany
I
MDR
info@streamcheck24.com
EUDAMED record
Report an error
Strena Medical Società Benefit
Italy
IIa
MDR
Website
info@d-heartcare.com
EUDAMED record
Report an error
Sunny Medical Device (Shenzhen)
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
IIb
MDR
EUDAMED record
Report an error
Sunoptictech FDA
EU representative : AJW Technology Consulting GmbH (Germany)
United States
I
MDR
EUDAMED record
Report an error
Sunwaymed
EU representative : SUNGO Europe B.V. (Netherlands)
China
VK-M3,VK-M4,VK-M5,VK-M6,VK-M510,VK-M520,VK-M530,VK-M540,VK-M610,VK-M620,VK-M630,VK-M640,VK-M650,VK-M660,VK-M670
I
MDR
EUDAMED record
Report an error
Surgease FDA
EU representative : Advena SRL (Italy)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@surgease.co.uk
EUDAMED record
Report an error
Surgerii
EU representative : Surgerii Robotics (Netherlands) B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Surgical Innovations FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Surgiris
France
I
MDR
Website
info@surgiris.com
EUDAMED record
Report an error
Surgiwell
Germany
I
MDR
service@surgiwell.de
EUDAMED record
Report an error
Sutter Medizintechnik FDA
Germany
IIb
MDR
Website
info@sutter-med.de
EUDAMED record
Report an error
Suzhou Anying Medical Equipment
EU representative : Llins Service & Consulting GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Suzhou Digital-health Care
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Suzhou Engin Bio-medical Electronics
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Suzhou Microclear Medical Instruments
EU representative : Wellkang Ltd (Northern Ireland)
China
I
MDR
EUDAMED record
Report an error
Suzhou Sunland Medical
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Suzhou Tedamed
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Suzhou Winmed Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Swissbionic
Switzerland
IIa
MDR
Website
EUDAMED record
Report an error
Sxt - Sistemi Per Telemedicina
Italy
IIa
MDR
Website
info@sxt-telemed.it
EUDAMED record
Report an error
Syai
EU representative : Luxus Lebenswelt GmbH (Germany)
Singapore
IIb
MDR
EUDAMED record
Report an error
Synapsor
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIb
MDR
RA_Group@synapsor.com
EUDAMED record
Report an error
Synapticmed FDA
EU representative : MDSS GmbH (Germany)
United States
IIb
MDR
Website
EUDAMED record
Report an error
Synaptive Medical FDA
EU representative : MDSS GmbH (Germany)
Canada
I
MDR
Website
service@synaptivemedical.com
EUDAMED record
Report an error
Syncrophi
Ireland
IIb
93/42
Website
Contactus@syncrophi.com
EUDAMED record
Report an error
SyncVision Technology
EU representative : MDSS GmbH (Germany)
Taiwan
I
MDR
EUDAMED record
Report an error
Syneika
France
IIb
93/42
Website
contact@syneika.com
EUDAMED record
Report an error
Synektik
Poland
I
MDR
Website
EUDAMED record
Report an error
SynexCare
Poland
IIa
MDR
EUDAMED record
Report an error
Systole
Netherlands
IIa
93/42
quality@systole.nl
EUDAMED record
Report an error
T-Tex
Italy
I
MDR
EUDAMED record
Report an error
T-Therapy Sagl
EU representative : V-ADVICES SRL (Italy)
Switzerland
I
MDR
EUDAMED record
Report an error
T.P.H. Pol-Intech
Poland
I
MDR
Website
info@pol-intech.pl
EUDAMED record
Report an error
Taiwan Main Orthopaedic Biotechnology FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
I
MDR
info@surglasses.com
EUDAMED record
Report an error
Talladium España FDA
Spain
IIa
MDR
EUDAMED record
Report an error
Talley Group FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
EUDAMED record
Report an error
Tao Technologies società a responsabilità limitata semplificata
Italy
I
MDR
Website
EUDAMED record
Report an error
Tappamed FDA
EU representative : Prolinx GmbH (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
Tavger FDA
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
Website
EUDAMED record
Report an error
Teasdale Healthcare Equipment
EU representative : Eurolink Europe Compliance Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
EUDAMED record
Report an error
Techmed
Poland
IIb
MDR
EUDAMED record
Report an error
Technologysrl
Italy
218806SA, 218808SB, 218810SB, 218810MB, 218812SB, 218812MB, 218814SB, 218814MB, 218811SB, 218811MB, 218816SB, 218816MB, 218818SB, 218818MB, 218820SB, 218820MB, 218823SB, 218823MB, 218825SB, 218825MB, 218828SB, 218828MB
IIa
MDR
Website
info@technologysrl.org
EUDAMED record
Report an error
Tecme FDA
EU representative : Emergo Europe B.V. (Netherlands)
Argentina
IIb
93/42
Website
EUDAMED record
Report an error
Tecnodent FDA
Italy
I
MDR
Website
info@tecnodent.com
EUDAMED record
Report an error
Tedansurgical FDA
EU representative : TeDan Surgical Innovations B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Tediro
Germany
I
MDR
Website
service@tediro.com
EUDAMED record
Report an error
Tehno Bionic
Romania
I
MDR
Website
EUDAMED record
Report an error
Tekmil
Türkiye
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
TeKne Dental
Italy
I
MDR
Website
info@teknedental.com
EUDAMED record
Report an error
Teknocer
Türkiye
I
MDR
info@teknocer.com.tr
EUDAMED record
Report an error
Tekscan FDA
EU representative : WMDE B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Telea Electronic Engineering FDA
Italy
IIb
MDR
Website
info@teleamedical.com
EUDAMED record
Report an error
Teljane
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
China
IIb
MDR
EUDAMED record
Report an error
Telmed
Germany
IIa
MDR
EUDAMED record
Report an error
Tema Sinergie
Italy
IIb
93/42
Website
EUDAMED record
Report an error
TeMeCo
Netherlands
IIa
MDR
Website
info@temeco.nl
EUDAMED record
Report an error
Temel
Spain
IIb
MDR
Website
EUDAMED record
Report an error
Tengyun Medical (Shenzhen)
EU representative : Obelis s.a. (Belgium)
China
IIb
MDR
EUDAMED record
Report an error
Teoresi MedTech
Italy
IIb
MDR
Website
info@mediconingegneria.it
EUDAMED record
Report an error
Terminter
Italy
IIb
93/42
Website
EUDAMED record
Report an error
Texinov
France
IIa
MDR
Website
EUDAMED record
Report an error
TF Health FDA
EU representative : Casus Europe B.V. (Netherlands)
United States
I
MDR
info@breezing.co
EUDAMED record
Report an error
Thondar
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Thornhill Research FDA
EU representative : Freyr Regulatory GmbH (Germany)
Canada
IIb
93/42
Website
info@thornhillmedical.com
EUDAMED record
Report an error
Thorsis
Germany
I
MDR
Website
info@thorsis.com
EUDAMED record
Report an error
Thrush International
EU representative : LORCAN & FYON B.V. (Netherlands)
Pakistan
I
MDR
EUDAMED record
Report an error
Tiantai Shengtengyun Medical Supplies FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
admin@zj-sty.com
EUDAMED record
Report an error
Tinavi FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
info@tinavi.com
EUDAMED record
Report an error
Tiscomed
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Tishyas Medical Device Development Solutions
EU representative : SUNGO Europe B.V. (Netherlands)
India
I
MDR
ravikiran@medevplus.com
EUDAMED record
Report an error
Tissium FDA
France
IIa
MDR
regulatory@tissium.com
EUDAMED record
Report an error
Titamed FDA
Belgium
IIa
MDR
Website
info@titamed.be
EUDAMED record
Report an error
Tonglu Qianyan Medtech FDA
EU representative : Firsteck Bio Srl. (Italy)
China
IIa
MDR
EUDAMED record
Report an error
Top Sale Spółka z ograniczoną odpowiedzialnością
Poland
I
MDR
info@bocioland.pl
EUDAMED record
Report an error
Totalgym
EU representative : Total Gym Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Tovacompany FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
93/42
Website
regulatory@tovacompany.com
EUDAMED record
Report an error
TraumaMed Solutions
EU representative : Real8 MedTech Ltd (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
qara@traumamedsolutions.com
EUDAMED record
Report an error
Troykamed
Türkiye
I
MDR
info@troykamed.com
EUDAMED record
Report an error
TScale Electronics Mfg. (Kunshan)
EU representative : JOYSUN GROUP S.L.U (Spain)
China
I
MDR
Website
EUDAMED record
Report an error
Ttbio FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Taiwan
IIa
MDR
Website
EUDAMED record
Report an error
Turkuazsaglik
Türkiye
I
MDR
Website
info@turkuazsaglik.com.tr
EUDAMED record
Report an error
Tympahealth FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
MDR
Website
QARA@tympahealth.com
EUDAMED record
Report an error
Typhung
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Tyromotion FDA
Austria
IIa
MDR
regulatoryaffairs@tyromotion.com
EUDAMED record
Report an error
UAB Kasko Group
Lithuania
I
MDR
Website
EUDAMED record
Report an error
Ultrazonic
Belgium
I
MDR
Website
info@ultrazonic.com
EUDAMED record
Report an error
Umanamedical
Malta
IIa
93/42
Website
info@umanamedical.com
EUDAMED record
Report an error
United Pacific Industries Pty FDA
EU representative : Advena Limited (Malta)
Australia
I
MDR
Website
enquiries@upi.com.au
EUDAMED record
Report an error
Universal Pain Technology Canada FDA
EU representative : AR Experts B.V. (Netherlands)
Canada
IIa
MDR
Website
info@spinemed.com
EUDAMED record
Report an error
UShare Medical FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
export@usharemedical.com
EUDAMED record
Report an error
Ust C&T
EU representative : SMGeurope OÜ (Estonia)
South Korea
I
MDR
EUDAMED record
Report an error
Vandijnen
Netherlands
I
MDR
Website
info@vandijnen.com
EUDAMED record
Report an error
Vapohealth FDA
EU representative : Share info GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Vcomin FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
info@vcomin.com
EUDAMED record
Report an error
VDI Technologies s.r.o
Czechia
IIa
MDR
Website
EUDAMED record
Report an error
Vectura Group FDA
EU representative : Vectura Ireland Limited (Ireland)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
EUDAMED record
Report an error
Vega Technologies FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
veldana medical
EU representative : Veranex Germany GmbH (Germany)
Switzerland
IIb
MDR
info@veldanamedical.ch
EUDAMED record
Report an error
Venclose FDA
EU representative : ICON (LR) Limited (Ireland)
United States
IIb
93/42
Website
EUDAMEDquery.PI@bd.com
EUDAMED record
Report an error
Venture Health
EU representative : Global E-commerce Experts Europe BV (Netherlands)
United Kingdom (ex Northern Ireland)
IIa
MDR
contact@venhealth.co.uk
EUDAMED record
Report an error
Vermund Larsen A S
Denmark
I
MDR
Website
mail@vela.dk
EUDAMED record
Report an error
Vertigocatcher
Sweden
I
MDR
Website
EUDAMED record
Report an error
Ves-Vacuum International
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Pakistan
I
MDR
EUDAMED record
Report an error
Vesticam
EU representative : Compliance Management Solutions Europe LTD (Bulgaria)
Australia
I
93/42
info@vesticam.com
EUDAMED record
Report an error
Vibrosense
Sweden
I
MDR
Website
info@vibrosense.com
EUDAMED record
Report an error
Vicon FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
I
93/42
Website
info@vicon.com
EUDAMED record
Report an error
View-M Technology FDA
EU representative : Obelis s.a. (Belgium)
South Korea
I
93/42
Website
qa1@viewmtechnology.com
EUDAMED record
Report an error
Vinno FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Virtus Technology Aps FDA
Denmark
I
MDR
info@virtusmonitor.com
EUDAMED record
Report an error
Vision Assessment
EU representative : MDSS GmbH (Germany)
United States
I
MDR
Website
sales@VisionAssessment.com
EUDAMED record
Report an error
Vissco
EU representative : AF Pharma Service Europe SL (Spain)
India
I
MDR
EUDAMED record
Report an error
Vistec
Germany
I
MDR
Website
info@vistec-ag.de
EUDAMED record
Report an error
Visuscience FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
Slit Lamp Microscope SL1911D,VSL-120,VSL-130,VSL-150,VSL-190,VSL-520,VSL-530,VSL-550,VSL-590,VSL-100,VSL-200 3 refs
I
MDR
info@visuscience.com
EUDAMED record
Report an error
VitalConnect FDA
EU representative : MDSS GmbH (Germany)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Vitali
Italy
IIa
MDR
Website
info@vitali.com
EUDAMED record
Report an error
Vitalsigns FDA
Sweden
I
MDR
Website
info@vitalsigns.se
EUDAMED record
Report an error
VitalSignum
Finland
IIa
93/42
Website
info@vitalsignum.com
EUDAMED record
Report an error
Vitromed FDA
EU representative : Obelis s.a. (Belgium)
India
I
MDR
Website
qa@vitromed.co.in
EUDAMED record
Report an error
Vivardis
France
IIa
MDR
Website
EUDAMED record
Report an error
Vivo Surgical
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Singapore
IIa
93/42
Website
regulatory@vivo-surgical.com
EUDAMED record
Report an error
VOCO FDA
Germany
I
MDR
Website
info@voco.de
EUDAMED record
Report an error
Vorotek FDA
EU representative : Emergo Europe B.V. (Netherlands)
Australia
I
MDR
Website
office@vorotek.com.au
EUDAMED record
Report an error
Vortran FDA
EU representative : Europecert UG (haftungsbeschränkt) (Germany)
United States
IIb
MDR
Website
info@vortran.com
EUDAMED record
Report an error
VPIX Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
South Korea
IIa
MDR
Website
ra@vpixmedical.com
EUDAMED record
Report an error
Vprecision Medical
EU representative : QJJ VIVA SL (Spain)
China
IIa
MDR
Website
EUDAMED record
Report an error
Vrmedical FDA
EU representative : BioDomi GmbH (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
Vulpés Electronics
Germany
I
MDR
Website
info@vulpes-electronics.com
EUDAMED record
Report an error
VUNO FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
MDR
Website
hello@vuno.co
EUDAMED record
Report an error
Waggoner Diagnostics
EU representative : E C REP LIMITED (Ireland)
United States
I
MDR
Website
EUDAMED record
Report an error
Wallaby Medical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
III
MDR
EUDAMED record
Report an error
Walz Elektronik FDA
Germany
IIb
MDR
Website
info@walz-el.de
EUDAMED record
Report an error
Warantec FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIa
93/42
EUDAMED record
Report an error
Warrenwell
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Warrior NP FDA
EU representative : AF Pharma Service Europe SL (Spain)
United States
I
MDR
Website
info@warriornp.com
EUDAMED record
Report an error
Weifang Mingliang Electronics FDA
EU representative : MedPath GmbH (Germany)
China
IIb
MDR
admin@mingliangkj.com
EUDAMED record
Report an error
Weirenmeditech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Weirich Medical Equipment (Tianjin)
EU representative : WEIRICH Medizintechnik GmbH (Germany)
China
IIb
93/42
Website
EUDAMED record
Report an error
Wellysis FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIa
93/42
info@wellysis.com
EUDAMED record
Report an error
Werunia
Germany
I
MDR
info@werunia.de
EUDAMED record
Report an error
Wever Instruments
EU representative : Advena Limited (Malta)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
WHITEsmile FDA
Germany
I
MDR
Website
info@whitesmile.com
EUDAMED record
Report an error
Widex A S
Denmark
IIa
93/42
Website
EUDAMED record
Report an error
Wieth Medical Systems e.K
Germany
I
MDR
Website
EUDAMED record
Report an error
WikiOptics
EU representative : Javitech Consulting GmbH (Germany)
South Korea
I
MDR
Website
contact@wikioptics.com
EUDAMED record
Report an error
WILAmed FDA
Germany
IIb
MDR
Website
info@wilamed.com
EUDAMED record
Report an error
William A Cook Australia Pty FDA
EU representative : COOK MEDICAL EUROPE LIMITED (Ireland)
Australia
IIa
93/42
Website
EUDAMED record
Report an error
Winncare FDA
Denmark
I
MDR
Website
info@ergolet.dk
EUDAMED record
Report an error
Wiseton
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Wonder
Germany
I
MDR
Website
mail@wonder.gmbh
EUDAMED record
Report an error
Wooyoungmed FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
EUDAMED record
Report an error
Woundel
France
IIa
MDR
contact@woundel.com
EUDAMED record
Report an error
Wudao Pu (Shenzhen) Technology
EU representative : Debao International GmbH (Germany)
China
Earwax removal and ear examination tools P13,P10,P12,P15,P50,P80,P90,N18,N19,N20,N21 3 refs
I
MDR
EUDAMED record
Report an error
Wuhan Zhaike Network Technology FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
info@anovator.com
EUDAMED record
Report an error
Xcellance Medical Technologies FDA
EU representative : Mars Medical (Germany)
India
I
MDR
ra@shalya.in
EUDAMED record
Report an error
Xenamed FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
Pakistan
I
MDR
Website
info@xenamed.com
EUDAMED record
Report an error
Xiaoniu Health
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Xuzhou Akx Electronic Science Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Yahorng FDA
EU representative : Kahl Handelsvertretung (Germany)
Taiwan
IIa
MDR
Website
EUDAMED record
Report an error
Yakebot
EU representative : PureCE B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Yasuico FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Japan
I
MDR
Website
info@yasuico.com
EUDAMED record
Report an error
Ybrain FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIa
93/42
Website
ra@ybrain.com
EUDAMED record
Report an error
Yearstar Healthcare Technology FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
info@yearstarcare.com
EUDAMED record
Report an error
Yellowriders
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Yiruide
EU representative : Wellkang Ltd (Northern Ireland)
China
IIb
MDR
Website
EUDAMED record
Report an error
Yiwu City Ange Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
YLAH
EU representative : VISAMED GmbH (Germany)
Switzerland
I
MDR
Website
info@ylah.ch
EUDAMED record
Report an error
Yoshida Dental Mfg FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
Japan
I
MDR
Website
EUDAMED record
Report an error
Youjiuhealth
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
YOUNG-IN biotech
EU representative : JaviTech e.K. (Germany)
South Korea
IIa
MDR
Website
qa@young-inbt.com
EUDAMED record
Report an error
Youngcoln
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
sales@youngcoln.com
EUDAMED record
Report an error
Yufo Biotech
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
support@xjwondfo.com.cn
EUDAMED record
Report an error
Zarys
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Zat
Czechia
IIb
MDR
Website
EUDAMED record
Report an error
Zdeer Industrial (Hubei)
EU representative : JOYSUN GROUP S.L.U (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Zenicor
Sweden
IIa
MDR
Website
info@zenicor.se
EUDAMED record
Report an error
Zevex FDA
EU representative : Abbott Ireland (Ireland)
United States
IIa
MDR
EUDAMED record
Report an error
Zhaoqing Yingguang Maoyi Youxian gongsi
EU representative : Everbiz GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Zhejiang Medstar Technology
EU representative : Obelis s.a. (Belgium)
China
I
MDR
Website
EUDAMED record
Report an error
Zhejiang New Vision Imp. & Exp
EU representative : REP Europe GmbH (Germany)
China
I
MDR
sales@paission.com
EUDAMED record
Report an error
Zhejiang Tiansong Medical Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
Zhejiang Unsurpassed Industry Trade
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Zhejiang Youyi Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
IIa
MDR
EUDAMED record
Report an error
Zhenfumedical
EU representative : Eunitor GmbH (Germany)
China
I
93/42
Website
Sales@zhenfumedical.com
EUDAMED record
Report an error
Zhenjiang Rapid Rehab & Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Zhongshan Jinli Electronic Weighing Equipment FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Zhucheng Binfei Medi-Tek
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
I
MDR
admin@binfei-medtek.com
EUDAMED record
Report an error
Zhuozhou Huanuo Life-Saving Equipment
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Ziacom Its
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Zive
Lithuania
IIa
93/42
Website
hello@zive.io
EUDAMED record
Report an error
Özden Tip Tibbi̇ Ci̇haz Ve Malzemeler Gida Teksti̇l Ti̇c Şti̇
Türkiye
I
MDR
info@ozdentip.com
EUDAMED record
Report an error
Üzümcü Hastane Eki̇pmanlari Metal İşleme Sanayi̇ Ve Ti̇caret A.Ş
Türkiye
I
MDR
Website
info@rustuuzumcu.com.tr
EUDAMED record
Report an error
Микромотор ООД
Bulgaria
IIa
MDR
Website
EUDAMED record
Report an error
Trauson
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
No model still on the market
China
140 others Drill Bit 14201300E 93/42 (no longer marketed) Drill Bit 19601700E 93/42 (no longer marketed) Drill Bit Centring Pin, Φ3.5 93/42 (no longer marketed) Drill Bit Centring Pin, Φ6.5 93/42 (no longer marketed) Drill Bit Drill , Φ4.3 2 refs 93/42 (no longer marketed) Drill Bit Drill, Φ3.3 93/42 (no longer marketed) Drill Bit Drill, Φ4 2 refs 93/42 (no longer marketed) Drill Bit Drill, Φ5.8, Cannulated 93/42 (no longer marketed) Drill Bit Drill, Φ6 93/42 (no longer marketed) Drill Bit Drill, Φ6.8, Cannulated 93/42 (no longer marketed) Drill Bit for Quick-connect Handle,Φ3.2 93/42 (no longer marketed) Drill Bit for Quick-connect Handle,Φ4.5 93/42 (no longer marketed) Drill Bit Locating Pin,φ4 93/42 (no longer marketed) Drill Bit Pin, Φ3.3 93/42 (no longer marketed) Drill Bit Reamer Tube, Φ3.5 93/42 (no longer marketed) Drill Bit Reamer Tube, Φ6.5 93/42 (no longer marketed) Drill Bit Shaft, Φ3.5 93/42 (no longer marketed) Drill Bit Shaft, Φ6.5 93/42 (no longer marketed) Drill Bit Step Drill Φ7.5/Φ4.9 93/42 (no longer marketed) Drill Bit Temporary Locking Nut Φ5×150 93/42 (no longer marketed) Drill Bit Temporary Locking Nut Φ5×180 93/42 (no longer marketed) Drill Bit Temporary Locking Nut Φ5×200 93/42 (no longer marketed) Drill Bit Φ1.7 Cannulated Dril Bit 93/42 (no longer marketed) Drill Bit Φ2.5 Cannulated Dril 93/42 (no longer marketed) Drill Bit Φ3.0 Cannulated Drill 93/42 (no longer marketed) Drill Bit Φ3.5/Φ2.9 93/42 (no longer marketed) Drill Bit Φ4 2 refs 93/42 (no longer marketed) Drill Bit Φ4.2 Cannulated Drill 93/42 (no longer marketed) Drill Bit Φ5 2 refs 93/42 (no longer marketed) Drill Bit Φ6 2 refs 93/42 (no longer marketed) Drill Bit Φ8 93/42 (no longer marketed) Drill Bit, Cannulated Φ5 93/42 (no longer marketed) Drill Bit, Φ1.1 2 refs 93/42 (no longer marketed) Drill Bit, Φ1.5 5 refs 93/42 (no longer marketed) Drill Bit, Φ1.7 93/42 (no longer marketed) Drill Bit, Φ1.8 93/42 (no longer marketed) Drill Bit, Φ1.9 2 refs 93/42 (no longer marketed) Drill Bit, Φ2.0 93/42 (no longer marketed) Drill Bit, Φ2.1 2 refs 93/42 (no longer marketed) Drill Bit, Φ2.5 2 refs 93/42 (no longer marketed) Drill Bit, Φ2.5 (quick) 93/42 (no longer marketed) Drill Bit, Φ2.5 mm 93/42 (no longer marketed) Drill Bit, Φ2.7 93/42 (no longer marketed) Drill Bit, Φ2.8 2 refs 93/42 (no longer marketed) Drill Bit, Φ3.0 93/42 (no longer marketed) Drill Bit, Φ3.0, Cannulated 93/42 (no longer marketed) Drill Bit, Φ3.5 2 refs 93/42 (no longer marketed) Drill Bit, Φ3.5 (quick) 93/42 (no longer marketed) Drill Bit, Φ3.5 mm 93/42 (no longer marketed) Drill Bit, Φ3.8 93/42 (no longer marketed) Drill Bit, Φ3.8, Cannulated 93/42 (no longer marketed) Drill Bit, Φ4.5 2 refs 93/42 (no longer marketed) Drill Bit, Φ4.8, Cannulated 93/42 (no longer marketed) Drill Bit, Φ5.8, Cannulated 93/42 (no longer marketed) Drill Bit, φ6.5 93/42 (no longer marketed) Drill Bit,Φ3.2 93/42 (no longer marketed) Drill Bit,φ4.0 93/42 (no longer marketed) Orthopaedic Instruments 10103500E 93/42 (no longer marketed) Orthopaedic Instruments 10110800E 93/42 (no longer marketed) Orthopaedic Instruments 10203500E 93/42 (no longer marketed) Orthopaedic Instruments 10403700E 93/42 (no longer marketed) Orthopaedic Instruments 13901100E 93/42 (no longer marketed) Orthopaedic Instruments 13901300E 93/42 (no longer marketed) Orthopaedic Instruments 19500800E 93/42 (no longer marketed) Orthopaedic Instruments 19602500E 93/42 (no longer marketed) Orthopaedic Instruments 19603000E 93/42 (no longer marketed) Orthopaedic Instruments Adjustable Drill Bit, φ2.4 93/42 (no longer marketed) Orthopaedic Instruments Adjustable Drill Bit, φ2.9 93/42 (no longer marketed) Orthopaedic Instruments Adjustable Drill Bit, φ3.2 93/42 (no longer marketed) Orthopaedic Instruments Countersink SR3 2 refs 93/42 (no longer marketed) Orthopaedic Instruments Countersink, Cannulated Φ4.0 93/42 (no longer marketed) Orthopaedic Instruments Countersink, Φ4 93/42 (no longer marketed) Orthopaedic Instruments Countersink, Φ4.47 93/42 (no longer marketed) Orthopaedic Instruments Countersink,SR4 93/42 (no longer marketed) Orthopaedic Instruments Drill Bit, φ3.3 2 refs 93/42 (no longer marketed) Orthopaedic Instruments Drill Bit, φ4.0 93/42 (no longer marketed) Orthopaedic Instruments Hexagonal Screwdriver, SW2.5 93/42 (no longer marketed) Orthopaedic Instruments T-handle Drill ,φ5 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,φ12 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,φ13 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,φ6 2 refs 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,φ7 2 refs 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,φ8 2 refs 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,φ9 2 refs 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,Ф10 93/42 (no longer marketed) Orthopaedic Instruments T-Handle Reamer,Ф11 93/42 (no longer marketed) Orthopaedic Instruments T-handled Drill,φ5 93/42 (no longer marketed) Orthopaedic Instruments T-handled Reamer,φ4 93/42 (no longer marketed) Orthopaedic Instruments φ2.9 Drill bit 93/42 (no longer marketed) Orthopaedic Instruments Φ5.6 Countersink, Cannulated 93/42 (no longer marketed) Reamers 10110400E 93/42 (no longer marketed) Reamers 10150100E 93/42 (no longer marketed) Reamers 10150500E 93/42 (no longer marketed) Reamers 10303100E 93/42 (no longer marketed) Reamers 10600500E 93/42 (no longer marketed) Reamers 10600600E 93/42 (no longer marketed) Reamers 14200400E 93/42 (no longer marketed) Reamers 14201400E 93/42 (no longer marketed) Reamers 19500300E 93/42 (no longer marketed) Reamers 19600400E 93/42 (no longer marketed) Reamers Flexible Reamer Head Φ12.5 93/42 (no longer marketed) Reamers Flexible Reamer Head Φ13 93/42 (no longer marketed) Reamers Flexible Reamer Head Φ14 2 refs 93/42 (no longer marketed) Reamers Flexible Reamer Head Φ15 2 refs 93/42 (no longer marketed) Reamers Flexible Reamer Head Φ6.5 93/42 (no longer marketed) Reamers Flexible Reamer Head Φ7 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ10 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ10.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ11 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ11.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ12 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ13.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ14.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ15.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ16 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ16.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ17 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ17.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ18 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ7.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ8 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ8.5 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ9 93/42 (no longer marketed) Reamers Flexible Reamer Head, Φ9.5 93/42 (no longer marketed) Reamers Flexible Reamer Shaft, Φ7.5 93/42 (no longer marketed) Reamers Flexible Reamer Shaft, Φ8.6 93/42 (no longer marketed) Φ1.6 Cone Drill Bit, Cannulated 93/42 (no longer marketed) Φ2.0 Cone Drill Bit, Cannulated 93/42 (no longer marketed) Φ2.0 Drill Bit 93/42 (no longer marketed) Φ2.0 Drill Bit for Quick-connect Handle 2 refs 93/42 (no longer marketed) Φ2.0 Drill Bit for Quick-connect Handle, Cannulated 93/42 (no longer marketed) Φ2.0 Drill Bit, Cannulated 93/42 (no longer marketed) Φ2.6 Cone Drill Bit, Cannulated 93/42 (no longer marketed) Φ2.7 Drill Bit 93/42 (no longer marketed) Φ2.7 Drill Bit for Quick-connect Handle 93/42 (no longer marketed) Φ2.7 Drill Bit for Quick-connect Handle, Cannulated 93/42 (no longer marketed) Φ2.7 Drill Bit, Cannulated 93/42 (no longer marketed) Φ3.0 Cone Drill Bit, Cannulated 93/42 (no longer marketed) Φ4.0 Cannulated Drill Bit 93/42 (no longer marketed) Φ4.3 Drill Bit 93/42 (no longer marketed)
I, IIa
93/42
EUDAMED record
Report an error
Mecta FDA
EU representative : ICON (LR) Limited (Ireland)
No model still on the market
United States
33 others
I, IIb
MDR, 93/42
Website
info@mectacorp.com
EUDAMED record
Report an error
Alliedmed FDA
EU representative : AR Experts B.V. (Netherlands)
No model still on the market
India
20 others
IIa, IIb
93/42
Website
sales@alliedmed.co.in
EUDAMED record
Report an error
Ypsomed FDA
EU representative : Ypsomed Produktion GmbH (Germany)
No model still on the market
Switzerland
16 others
IIa, IIb
93/42
EUDAMED record
Report an error
Dadeh Gostaran Dena
EU representative : Eska Diagnostics Kft (Hungary)
No model still on the market
Iran
12 others
I
MDR
Website
info@dgdena.com
EUDAMED record
Report an error
NEXA Medical FDA
EU representative : Advena Limited (Malta)
No model still on the market
United Kingdom (ex Northern Ireland)
6 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
Meditech International FDA
EU representative : Obelis s.a. (Belgium)
No model still on the market
Canada
5 others
IIa, IIb
93/42
Website
regulatory@bioflexlaser.com
EUDAMED record
Report an error
Origin Medical Devices FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
No model still on the market
United States
IIb
93/42
Website
EUDAMED record
Report an error
Ascent Meditech
EU representative : Mars Medical (Germany)
No model still on the market
India
I
MDR
Website
regulatory@ascentmeditech.com
EUDAMED record
Report an error
Edap Tms France FDA
No model still on the market
France
I, IIb
MDR, 93/42
Website
serviceAR@focaltherics.com
EUDAMED record
Report an error
Novin Electronics & Electrical Industries Engineering
EU representative : Obelis s.a. (Belgium)
No model still on the market
Iran
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Shenzhen Peninsula Medical Group FDA
EU representative : Share info GmbH (Germany)
No model still on the market
China
IIa
93/42
EUDAMED record
Report an error
Surgical Equipment
EU representative : OMC NI MEDICAL LIMITED (Northern Ireland)
No model still on the market
India
I
MDR
EUDAMED record
Report an error
Apex (Guangzhou) Tools & Orthopedics
EU representative : Wellkang Ltd (Northern Ireland)
No model still on the market
China
IIa
93/42
Website
EUDAMED record
Report an error
Avihealthcare
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
India
IIa, IIb
MDR
sales@avihealthcare.com
EUDAMED record
Report an error
Diagnostic Devices Development
No model still on the market
Finland
IIa
93/42
Website
info@ddd-medical.com
EUDAMED record
Report an error
Fanem
EU representative : Obelis s.a. (Belgium)
No model still on the market
India
IIa
MDR, 93/42
Website
info@fanem.in
EUDAMED record
Report an error
Injeq
No model still on the market
Finland
I, IIa
MDR
Website
qa@injeq.com
EUDAMED record
Report an error
Renalyx
EU representative : Amstermed B.V. (Netherlands)
No model still on the market
India
IIb
93/42
Website
EUDAMED record
Report an error
Respironics Respiratory Drug Delivery (UK) FDA
EU representative : Philips Medical Systems Nederland B.V. (Netherlands)
No model still on the market
United Kingdom (ex Northern Ireland)
I, IIa
93/42
eudamed@philips.com
EUDAMED record
Report an error
1M4
No model still on the market
Estonia
I
MDR
Website
info@1m4.eu
EUDAMED record
Report an error
Arctiko
No model still on the market
Denmark
IIa
93/42
Website
info@arctiko.com
EUDAMED record
Report an error
Asensus FDA
No model still on the market
Italy
IIb
MDR
EUDAMED record
Report an error
Cerenion
No model still on the market
Finland
IIb
93/42
Website
info@cerenion.com
EUDAMED record
Report an error
Chalice Medical FDA
EU representative : MedEnvoy Global BV (Netherlands)
No model still on the market
United Kingdom (ex Northern Ireland)
IIb
93/42
Website
regulatoryaffairs@chalicemedical.com
EUDAMED record
Report an error
Charco Neurotech
EU representative : European Healthcare & Device Solutions Ltd. (Ireland)
No model still on the market
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@charconeurotech.com
EUDAMED record
Report an error
Chengdu Wesley Bioscience Technology
EU representative : Prolinx GmbH (Germany)
No model still on the market
China
IIb
93/42
Website
EUDAMED record
Report an error
Cmics
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
No model still on the market
China
IIa
93/42
Website
info@cmics.com.cn
EUDAMED record
Report an error
Dive Medical
No model still on the market
Spain
IIa
MDR
Website
info@dive-medical.com
EUDAMED record
Report an error
Focus Surgery
EU representative : CEpartner4U (Netherlands)
No model still on the market
United States
IIb
93/42
info@sonablate.com
EUDAMED record
Report an error
Hailimedical FDA
EU representative : phoenix Medtech GmbH (Germany)
No model still on the market
China
IIa
MDR
EUDAMED record
Report an error
Imaginecare
No model still on the market
Sweden
I
93/42
Website
regulatory@imaginecare.com
EUDAMED record
Report an error
Indiba FDA
No model still on the market
Spain
IIa
MDR
Website
regulatory@indiba.com
EUDAMED record
Report an error
Innokas Yhtymä FDA
No model still on the market
Finland
IIb
93/42
Website
prrc@innokasmedical.fi
EUDAMED record
Report an error
Mofixx
No model still on the market
Netherlands
I
MDR
Website
info@mofixx.com
EUDAMED record
Report an error
Ns Biotec
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
Egypt
–
98/79
Website
info@nsbiotec.com
EUDAMED record
Report an error
O R Pty FDA
EU representative : Obelis s.a. (Belgium)
No model still on the market
Australia
I
MDR
Website
EUDAMED record
Report an error
Quince Therapeutics
No model still on the market
Italy
IIb
MDR
Website
EUDAMED record
Report an error
Roboptics
No model still on the market
Portugal
I
93/42
Website
EUDAMED record
Report an error
Suzhou Insy Medical Tecnology
EU representative : GRZAN GROUP SL (Spain)
No model still on the market
China
I
MDR
EUDAMED record
Report an error
Takagi seiko FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
Japan
IIa
93/42
EUDAMED record
Report an error
Wuhan United Imaging Surgical
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
No model still on the market
China
IIa
MDR
EUDAMED record
Report an error