Instruments for functional explorations and therapeutic interventions

Instruments to support and monitor vital signs

EMDN code Z1203

481 manufacturers, 4,436 models including 4,186 on the market, 38 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 481

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Respironics FDA EU representative : Respironics Deutschland GmbH & Co.KG (Germany)	United States	(10) Bacterial/Viral Filter 113577693/42 (10) Circuit,Disp,15mm,Non-Htd,Dual Limb 112730793/42 (10) Circuit,Disp,22mm,Non-Htd,Active 113234493/42 (10) Circuit,Disp,22mm,Non-Htd,Dual Limb 112730693/42 (10) Disposable Active Exhalation Valve 113166193/42 602 others 4LXTB,6IN TRACH 15MM TAPER,CE 100496893/42 Active Exhalation Device Kit 106565993/42 Active Exhalation Device with PAP 105371693/42 Adult Invasive Passive Disposable Non-Heated Wire Circuit 106944393/42 Adult Non-Invasive Passive Disposable Non-Heated Circuit 106946793/42 Aeris EVO93/42 BeLife 40 Pro SPX3100S1993/42 BiPAP A40 Pro AR ARX3100S1993/42 BiPAP A40 Pro BR BRX3100S1893/42 BiPAP A40 Pro Titration Rental Program AU RAUX3100S1993/42 BiPAP A40 Pro Titration Rental Program BL RBLX3100S1993/42 BiPAP A40 Pro Titration Rental Program BR RBRX3100S1993/42 BiPAP A40 Pro Titration Rental Program CA RCAX3100S1293/42 BiPAP A40 Pro Titration Rental Program DE RDEX3100S1393/42 BiPAP A40 Pro Titration Rental Program EE REEX3100S1993/42 BiPAP A40 Pro Titration Rental Program ES RESX3100S1993/42 BiPAP A40 Pro Titration Rental Program FR RFRX3100S1993/42 BiPAP A40 Pro Titration Rental Program GB RGBX3100S1993/42 BiPAP A40 Pro Titration Rental Program IN RINX3100S1993/42 BiPAP A40 Pro Titration Rental Program IT RITX3100S2193/42 BiPAP A40 Pro Titration Rental Program ND RNDX3100S1993/42 BiPAP A40 Pro, AU AUX3100S1993/42 BiPAP A40 Pro, BL BLX3100S1993/42 BiPAP A40 Pro, CA CAX3100S1293/42 BiPAP A40 Pro, CA w/Heated Tube Humid CAX3100T1293/42 BiPAP A40 Pro, DE DEX3100S1393/42 BiPAP A40 Pro, EE EEX3100S1993/42 BiPAP A40 Pro, ES ESX3100S1993/42 BiPAP A40 Pro, ES w/Heated Humidifier ESX3100H1993/42 BiPAP A40 Pro, ES w/Heated Tube Humid ESX3100T1993/42 BiPAP A40 Pro, FR FRX3100S1493/42 BiPAP A40 Pro, FR w/Heated Humidifier FRX3100H1493/42 BiPAP A40 Pro, FR w/Heated Tube Humid FRX3100T1493/42 BiPAP A40 Pro, IA IAX3100S1993/42 BiPAP A40 Pro, IA w/Heated Humidifier IAX3100H1993/42 BiPAP A40 Pro, IA w/Heated Tube Humid IAX3100T1993/42 BiPAP A40 Pro, Intl INX3100S1993/42 BiPAP A40 Pro, Intl w/Heated Humidifier INX3100H1993/42 BiPAP A40 Pro, Intl w/Heated Tube Humid INX3100T1993/42 BiPAP A40 Pro, IT ITX3100S2193/42 BiPAP A40 Pro, IT w/Heated Humidifier ITX3100H2193/42 BiPAP A40 Pro, IT w/Heated Tube Humid ITX3100T2193/42 BiPAP A40 Pro, ND NDX3100S1993/42 BiPAP A40 Pro, UK GBX3100S1993/42 BiPAP A40 Pro, UK w/Heated Humidifier GBX3100H1993/42 BiPAP A40 Pro, UK w/Heated Tube Humid GBX3100T1993/42 BiPAP A40 Sapio Belife93/42 BiPAP Auto BiFlex, System One 60 Series, ES REMstar System (60 Series)93/42 BiPAP Disposable Circuit, Box/10 31210793/42 Circuit Filter DEP w/FEP Filter 10PK INTL Single Use Filtered Exhalation Port Circuit93/42 Circuit Filter DEP w/FEP Filter Single, Intl 107394993/42 Circuit Filter DEP w/FEP Single, Intl 107394893/42 Circuit, DEP w/FEP, INTL, 10 Pack 106921093/42 Circuit, Disposable, 15mm, Non-Heated, Passive 113233993/42 Circuit, Disposable, 22mm, Adult, Non-Heated Passive 113234093/42 CoughAssist E70 Accessories CA70 SERIES,CIRCUIT,ADULT LG.,6FT93/42 Disp Ext Flow Sensor,Adult/Ped, 10 pk 114649793/42 Disposable Adult Active Circuit no H20 Trap 20 pk 107323293/42 Disposable Adult Active Circuit no H2O Trap 107322393/42 Disposable Adult Passive Circuit no H20 Trap 20 pk 107323693/42 Disposable Adult Passve Circuit no H2O Trap 107322893/42 Disposable Ext Flow Sensor,Ped/Inf, 10pk 114655893/42 Disposable Pediatric Active Circuit with H20 Trap 20 pk 107322993/42 Disposable Pediatric Circuit with H20 Trap 107322093/42 Disposable Pediatric Passive Circuit with H20 Trap 20 pk 107323393/42 Disposable Pediatric Passive Circuit with H2O Trap 107322493/42 Disposable Swivel Passive Exhalation Port 113990993/42 Dorma 200 w/Humid, INTL93/42 Dorma 200, INTL93/42 Dorma 500 Auto, w/ Humid, DE REMstar System (60 Series)93/42 DreamSt BiPAP AVAPS 30 AE w/HTD Humid, No Btooth, INTL INX1131H1993/42 DreamSt BiPAP AVAPS30 w/Humid, AAM,VitalAire,Vitalvent VTX1130H2493/42 DreamSt BiPAPAVAPS30, w/Humid MedicAir, RespiComfort MDX1130H2593/42 DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, ES93/42 DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, IT93/42 DreamStation 2 Auto CPAP Advanced Humid/P Flex/Cell/BT, FR FRX521H14C93/42 DreamStation 2 Auto CPAP Advanced Humidifier/Bluetooth® only, DE93/42 DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, EE93/42 DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, ND93/42 DreamStation 2 Auto CPAP Advanced w/Humidifier/Cell/Bluetooth, DE DreamStation 2 Advanced CPAP/Auto CPAP93/42 DreamStation 2 Auto CPAP Humid/Cell/BT, IT93/42 DreamStation 2 Auto CPAP w/ Humidifier/Cell/Bluetooth, EE DreamStation 2 CPAP/Auto CPAP93/42 DreamStation 2 CPAP Advanced Humid/BT only, EU93/42 DreamStation 2 CPAP Advanced Humid/Cell/BT, ES93/42 DreamStation 2 CPAP Advanced Humid/Cell/BT, GB93/42 DreamStation 2 CPAP AdvancedHumid/Cell/BT, EU93/42 DreamStation 2 CPAP w/ Humidifier/Cell/ Bluetooth, EE93/42 DreamStation 2 CPAP w/Humidifier/Bluetooth only, ES DreamStation 2 CPAP/Auto CPAP93/42 DreamStation Atuo CPAP w/Cell, ND NDX500S15C93/42 DREAMSTATION AUTO BIPAP W/HUMID Cell LA LAX700H15C93/42 DreamStation Auto BiPAP w/Humid, w/H Tube, AU AUX700T1593/42 DreamStation Auto BiPAP w/Humid, w/H Tube, INTL INX700T1593/42 DreamStation Auto BiPAP w/Humid, w/H Tube, LA LAX700T1593/42 DreamStation Auto BiPAP w/Humid, w/H Tube, w/Cell, AU AUX700T15C93/42 DreamStation Auto BiPAP with Humidifier, AR ARX700H1593/42 DreamStation Auto BiPAP with Humidifier, AU AUX700H1593/42 DreamStation Auto BiPAP with Humidifier, BL BLX700H1593/42 DreamStation Auto BiPAP with Humidifier, EE EEX700H1593/42 DreamStation Auto BiPAP with Humidifier, ES ESX700H1593/42 DreamStation Auto BiPAP with Humidifier, EU EUX700H1593/42 DreamStation Auto BiPAP with Humidifier, GB GBX700H1593/42 DreamStation Auto BiPAP with Humidifier, INTL INX700H1593/42 DreamStation Auto BiPAP with Humidifier, ND NDX700H1593/42 DreamStation Auto BiPAP with Humidifier, TR TRX700H1593/42 DreamStation Auto BiPAP, AR ARX700S1593/42 DreamStation Auto BiPAP, AU AUX700S1593/42 DreamStation Auto BiPAP, BL BLX700S1593/42 DreamStation Auto BiPAP, DE DEX700S1393/42 DreamStation Auto BiPAP, EE EEX700S1593/42 DreamStation Auto BiPAP, ES ESX700S1593/42 DreamStation Auto BiPAP, FR FRX700S1493/42 DreamStation Auto BiPAP, GB GBX700S1593/42 DreamStation Auto BiPAP, GB Rental RGBX700S1593/42 DreamStation Auto BiPAP, INTL INX700S1593/42 DreamStation Auto BiPAP, IT ITX700S1593/42 DreamStation Auto BiPAP, LA LAX700S1593/42 DreamStation Auto BiPAP, Latin America LAX700H1593/42 DreamStation Auto BiPAP, ND NDX700S1593/42 DreamStation Auto BiPAP, Ukraine UAX700S1593/42 DreamStation Auto BiPAP, US EUX700S1593/42 DreamStation Auto CPAP Cell, BL BLX500S15C93/42 DreamStation Auto CPAP Humidifier, Mediq BLX500H15MQ93/42 DreamStation Auto CPAP w/Cell ES ESX500S15C93/42 DreamStation Auto CPAP w/Humid w/H Tube, AU AUX500T1593/42 DreamStation Auto CPAP w/Humid w/H Tube, INTL INX500T1593/42 DreamStation Auto CPAP w/Humid w/H Tube, w/Cell, AU AUX500T15C93/42 DreamStation Auto CPAP w/Humid, GB Rent RGBX500H1593/42 DREAMSTATION AUTO CPAP W/HUMIDCell, LA LAX500H15C93/42 DREAMSTATION AUTO CPAP W/HUMIDIFIER Cell ARX500H15C93/42 DreamStation Auto CPAP w/Humidifier, w/Cell, Praxair, PT PTX500H15PRC93/42 DreamStation Auto CPAP w/Humidifier, w/H Tube, LA LAX500T1593/42 DreamStation Auto CPAP w/Humidifier, w/WiFi, IT ITX500H15W93/42 DreamStation Auto CPAP w/Humidifier, w/WiFi, Praxair, PT PTX500H15PRW93/42 DreamStation Auto CPAP w/Humidifier/Cell, BL BLX500H15C93/42 DreamStation Auto CPAP w/Humidifier/Cell, ND NDX500H15C93/42 DreamStation Auto CPAP w/ith Humidifier/Cell ES ESX500H15C93/42 DreamStation Auto CPAP w/WiFi, FR FRX500S14W93/42 DreamStation Auto CPAP with Humidifier, AR ARX500H1593/42 DreamStation Auto CPAP with Humidifier, AU AUX500H1593/42 DreamStation Auto CPAP with Humidifier, BL BLX500H1593/42 DreamStation Auto CPAP with Humidifier, EE EEX500H1593/42 DreamStation Auto CPAP with Humidifier, ES ESX500H1593/42 DreamStation Auto CPAP with Humidifier, EU EUX500H1593/42 DreamStation Auto CPAP with Humidifier, GB GBX500H1593/42 DreamStation Auto CPAP with Humidifier, INTL INX500H1593/42 DreamStation Auto CPAP with Humidifier, Latin America LAX500H1593/42 DreamStation Auto CPAP with Humidifier, ND NDX500S1593/42 DreamStation Auto CPAP with Humidifier, Praxair, PT PTX500H15PR93/42 DreamStation Auto CPAP with Humidifier, TR TRX500H1593/42 DreamStation Auto CPAP, AR ARX500S1593/42 DreamStation Auto CPAP, AU AUX500S1593/42 DreamStation Auto CPAP, BL BLX500S1593/42 DreamStation Auto CPAP, DE DEX500S1393/42 DreamStation Auto CPAP, EE EEX500S1593/42 DreamStation Auto CPAP, ES ESX500S1593/42 DreamStation Auto CPAP, EU EUX500S1593/42 DreamStation Auto CPAP, FR FRX500S1493/42 DreamStation Auto CPAP, GB GBX500S1593/42 DreamStation Auto CPAP, GB Rental RGBX500S1593/42 DreamStation Auto CPAP, INTL93/42 DreamStation Auto CPAP, IT ITX500S1593/42 DreamStation Auto CPAP, Latin America LAX500S1593/42 DreamStation Auto CPAP, ND NDX500H1593/42 DreamStation Auto CPAP, TR TRX500S1593/42 DreamStation Auto CPAP, Ukraine UAX500S1593/42 DreamStation Auto FR Recert UFRX500S1493/42 DreamStation autoSV with Humidifier, no Bluetooth, LA LAX900H1993/42 DreamStation AutoSV, Ukraine UAX900S1593/42 DreamStation AVAPS 25 w/Heated Humidifier, No Bluetooth, EU EUX1125H1993/42 DreamStation AVAPS 25 w/Hum,no Bluetooth, INTL INX1125H1993/42 DreamStation AVAPS 25 w/Humid w/H Tube, no Bluetooth, INTL INX1125T1993/42 DreamStation AVAPS 25, EU EUX1125S1593/42 DreamStation AVAPS 25, IT ITX1125S2193/42 DreamStation AVAPS 25, No Bluetooth, EU EUX1125S1993/42 DreamStation AVAPS 25, no Bluetooth, Intl INX1125S1993/42 DreamStation AVAPS 30 AAM ND NDX1130S1593/42 DreamStation AVAPS 30 AAM w/Hum,no Bluetooth, INTL INX1130H1993/42 DreamStation AVAPS 30 AAM, no Bluetooth, INTL INX1130S1993/42 DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, INTL INX1131T1993/42 DreamStation AVAPS 30 with Heated Humidifier, AAM ND NDX1130H1593/42 DreamStation AVAPS 30 with Heated Humidifier, ND NDX1130H2093/42 DreamStation AVAPS 30, ND NDX1130S2093/42 DreamStation AVAPS30 AAM, VT VTX1130S2493/42 DreamStation BiPAP Auto Rental RDEX700S1393/42 DreamStation BiPAP autoSV , No Bluetooth, EU EUX900S1993/42 DreamStation BiPAP autoSV w/ Humid, DE Rental RDEX900H1393/42 DreamStation BiPAP autoSV w/ Humid, GB Rental RGBX900H1593/42 DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU AUX900T15C93/42 DreamStation BiPAP autoSV w/humid w/h tube, no bluetooth, LA LAX900T1993/42 DreamStation BiPAP autoSV w/Humid, No Bluetooth, EU EUX900H1993/42 DreamStation BiPAP autoSV w/Humid, no Bluetooth, INTL INX900H1993/42 DreamStation BiPAP autoSV w/Humid, no Bluetooth, ZA ZAX900H1993/42 DreamStation BiPAP autoSV w/Humidifier, AU AUX900T1593/42 DreamStation BiPAP autoSV w/Humidifier, BL BLX900H1593/42 DreamStation BiPAP autoSV w/Humidifier, ES ESX900H1593/42 DreamStation BiPAP autoSV w/Humidifier, TR TRX900H1593/42 DreamStation BiPAP AutoSV with Humidifier, FR FRX900H1493/42 DreamStation BiPAP autoSV with Humidifier, ND NDX900H1593/42 DreamStation BiPAP autoSV with WiFi, FR FRX900S14W93/42 DreamStation BiPAP autoSV, AU AUX900S1593/42 DreamStation BiPAP autoSV, BL BLX900S1593/42 DreamStation BiPAP AutoSV, DE DEX900S1393/42 DreamStation BiPAP autoSV, DE Rental RDEX900S1393/42 DreamStation BiPAP AutoSV, EE EEX900S1593/42 DreamStation BiPAP autoSV, ES ESX900S1593/42 DreamStation BiPAP AutoSV, EU EUX900S1593/42 DreamStation BiPAP AutoSV, FR FRX900S1493/42 DreamStation BiPAP AutoSV, GB GBX900S1593/42 DreamStation BiPAP autoSV, GB Rental RGBX900S1593/42 DreamStation BiPAP AutoSV, IT ITX900S1593/42 DreamStation BiPAP autoSV, ND NDX900S1593/42 DreamStation BiPAP autoSV, no Bluetooth, INTL INX900S1993/42 Dreamstation BiPAP autoSV, no Bluetooth, LA LAX900S1993/42 DreamStation BiPAP autoSV, no Bluetooth, ZA ZAX900S1993/42 DreamStation BiPAP autoSV, TR TRX900S1593/42 DreamStation BiPAP autoSV, w/Hum w/HTube, no BT, INTL INX900T1993/42 DreamStation BiPAP AVAPS 30 AAM no Bluetooth, EU EUX1130S1993/42 DreamStation BiPAP AVAPS 30 AAM, ES ESX1130S1593/42 DreamStation BiPAP AVAPS 30 AAM, EU EUX1130S1593/42 DreamStation BiPAP AVAPS 30 AE No Bluetooth. INTL INX1131S1993/42 DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU AUX1131T1593/42 DreamStation BiPAP AVAPS 30 AE, AU AUX1131S1593/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier AAM, FR FRX1130H1493/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM DE DEX1130H1393/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EE EEX1130H2293/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EU EUX1130H1593/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, EU EUX1125H1593/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, GB GBX1130H2093/42 DreamStation BiPAP AVAPS 30 w/HTD Humid, No BT, EU EUX1130H1993/42 DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, INTL INX1130T1993/42 DreamStation BiPAP AVAPS 30, AAM w/ Humidifier, ES ESX1130H1593/42 DreamStation BiPAP AVAPS 30, GB GBX1130S2093/42 DreamStation BiPAP AVAPS 30, IT ITX1130S2193/42 DreamStation BiPAP AVAPS30 AAM BL BLX1130S1593/42 DreamStation BiPAP AVAPS30 AAM no Bluetooth, UA UAX1130S1993/42 DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA ZAX1130H1993/42 DreamStation BiPAP AVAPS30 AAM w/Humid, NO Bluetooth, UA UAX1130H1993/42 DreamStation BiPAP AVAPS30 AAM w/Humidifier, BL BLX1130H1593/42 DreamStation BiPAP AVAPS30 AAM w/Humidifier, TR TRX1130H1593/42 DreamStation BiPAP AVAPS30 AAM, EE EEX1130S2293/42 DreamStation BiPAP AVAPS30 AAM, FR FRX1130S1493/42 DreamStation BiPAP AVAPS30 AAM, Linde EOLUS LDX1130S2393/42 DreamStation BiPAP AVAPS30 AAM, MedicAir, Respi Comfort MDX1130S2593/42 DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA ZAX1130S1993/42 DreamStation BiPAP AVAPS30 AAM, TR TRX1130S1593/42 DreamStation BiPAP AVAPS30 AAM, w/ Humidifier,Linde EOLUS LDX1130H2393/42 DreamStation BiPAP AVAPS30 AE AAM w/Humidifier, AU AUX1131H1593/42 DreamStation BiPAP AVAPS30 AE w/Cell, AU AUX1131S15C93/42 DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU AUX1131T15C93/42 DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WiFi AU AUX1131T15W93/42 DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, AU AUX1131H15C93/42 DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AU AUX1131H15W93/42 DreamStation BiPAP AVAPS30 AE w/WiFi, AU AUX1131S15W93/42 DreamStation BiPAP AVAPS30 with Humidifier, SP SPX1130H2193/42 DreamStation BiPAP AVAPS30, GB Rental RGBX1130S2093/42 DreamStation BiPAP AVAPS30, SP SPX1130S2193/42 DREAMSTATION BIPAP PRO W/HUMID Cell LA LAX600H15C93/42 DreamStation BiPAP Pro w/Humid w/H Tube, Latin America LAX600T1593/42 DreamStation BiPAP Pro w/Humidi w/H Tube, INTL INX600T1593/42 DreamStation BiPAP Pro with Humidifier, AR ARX600H1593/42 DreamStation BiPAP Pro with Humidifier, EU EUX600H1593/42 DreamStation BiPAP Pro with Humidifier, INTL INX600H1593/42 DreamStation BiPAP Pro with Humidifier, Latin America LAX600H1593/42 DreamStation BiPAP Pro with Humidifier, TR TRX600H1593/42 DreamStation BiPAP Pro, AR ARX600S1593/42 DreamStation BiPAP Pro, BL BLX600S1593/42 DreamStation BiPAP Pro, EU EUX600S1593/42 DreamStation BiPAP Pro, INTL INX600S1593/42 DreamStation BiPAP Pro, Latin America LAX600S1593/42 DREAMSTATION BIPAP PRO,Cell Modem, AR ARX600S15C93/42 DreamStation BiPAP S/T 25 w/ HTD Humid, No BT, EU EUX1025H1993/42 DreamStation BiPAP S/T 25 w/Heated Humidifier, EU EUX1025H1593/42 DreamStation BiPAP S/T 25, DE DEX1025S1393/42 DreamStation BiPAP S/T 25, EU EUX1025S1593/42 DreamStation BiPAP S/T 25, no Bluetooth, EU EUX1025S1993/42 DreamStation BiPAP S/T 30 AAM , No Bluetooth, EU EUX1030S1993/42 DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, ES ESX1030H1593/42 DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, EU EUX1030H1593/42 DreamStation BiPAP S/T 30 AAM, DE DEX1130S1393/42 DreamStation BiPAP S/T 30 AAM, EU EUX1030S1593/42 DreamStation BiPAP S/T 30 with Heated Humidifier, GB GBX1030H2093/42 DreamStation BiPAP S/T 30, GB GBX1030S2093/42 DreamStation BiPAP S/T ST30 AAM, ES ESX1030S1593/42 DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL INX1025T1993/42 DreamStation BiPAP S/T25, No Bluetooth, IN INX1025H1993/42 DreamStation BiPAP S/T25, no Bluetooth, INTL INX1025S1993/42 DreamStation BiPAP S/T30 AAM BL BLX1030S1593/42 DreamStation BiPAP S/T30 AAM no Bluetooth, INTL INX1030S1993/42 DreamStation BiPAP S/T30 AAM TR TRX1030S1593/42 DreamStation BiPAP S/T30 AAM w/Hum w/HTube, no BT,INTL INX1030T1993/42 DreamStation BiPAP S/T30 AAM w/Hum, no Bluetooth, ZA ZAX1030H1993/42 DreamStation BiPAP S/T30 AAM w/Humidifier, BL BLX1030H1593/42 DreamStation BiPAP S/T30 AAM w/Humidifier, DE DEX1030H1393/42 DreamStation BiPAP S/T30 AAM w/Humidifier, TR TRX1030H1593/42 DreamStation BiPAP S/T30 AAM, DE DEX1030S1393/42 DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA ZAX1030S1993/42 DreamStation BiPAP S/T30 w/ Humidifier, ES ESX1030H2093/42 DreamStation BiPAP S/T30 w/Hum,no Bluetooth,AAM INTL INX1030H1993/42 DreamStation BiPAP S/T30 with Humidifier, IT ITX1030H2093/42 DreamStation BiPAP S/T30, EE EEX1030S2293/42 DreamStation BiPAP S/T30, ES ESX1030S2093/42 DreamStation BiPAP S/T30, IT ITX1030S2093/42 DreamStation BiPAP ST30 AAM no Bluetooth, UA UAX1030S1993/42 DreamStation BiPAP ST30 AAM w/Humid, no Bluetooth, UA UAX1030H1993/42 DreamStation BiPAP Synchrony AVAPS AAM SAX1130S2793/42 DreamStation BiPAP Synchrony AVAPS AAM, with Humidifier SAX1130H2793/42 DreamStation CPAP Pro Cell, BL BLX400S15C93/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, AR ARX401H1593/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, ES ESX401H1593/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, EU EUX401H1593/42 DreamStation CPAP Pro w/ Auto-Trial, EU EUX401S1593/42 DreamStation CPAP Pro w/Cell ES ESX401S15C93/42 DREAMSTATION CPAP PRO W/HUMID Cell LA LAX400H15C93/42 DreamStation CPAP Pro w/Humid w/H Tube, INTL INX400T1593/42 DreamStation CPAP Pro w/Humid w/H Tube, LA LAX400T1593/42 DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, AU AUX400T15C93/42 DreamStation CPAP Pro w/Humid w/Heated Tube, AU AUX400T1593/42 DreamStation CPAP Pro w/Humid, PW, 22mm PWX401H1593/42 DREAMSTATION CPAP PRO W/HUMIDIFIER, Cell ARX401H15C93/42 DreamStation CPAP Pro w/Humidifier, w/WiFi, IT ITX400H15W93/42 DreamStation CPAP Pro w/Humidifier/Cell, BL BLX400H15C93/42 DreamStation CPAP Pro with C Flex with Humidifier, GB GBX401H1593/42 DreamStation CPAP Pro with C-Flex, AR ARX401S1593/42 DreamStation CPAP Pro with C-Flex, ES ESX401S1593/42 DreamStation CPAP Pro with C-Flex, GB GBX401S1593/42 DreamStation CPAP Pro with Humidifier, AU AUX400H1593/42 DreamStation CPAP Pro with Humidifier, BL BLX400H1593/42 DreamStation CPAP Pro with Humidifier, EE EEX400H1593/42 DreamStation CPAP Pro with Humidifier, ES ESX400H1593/42 DreamStation CPAP Pro with Humidifier, EU EUX400H1593/42 DreamStation CPAP Pro with Humidifier, GB GBX400H1593/42 DreamStation CPAP Pro with Humidifier, INTL INX400H1593/42 DreamStation CPAP Pro with Humidifier, Latin America LAX400H1593/42 DreamStation CPAP Pro with Humidifier, TR TRX400H1593/42 DreamStation CPAP Pro with Humidifier/Cell ES ESX401H15C93/42 DreamStation CPAP Pro, AU AUX400S1593/42 DreamStation CPAP Pro, BL BLX400S1593/42 DreamStation CPAP Pro, DE DEX400S1393/42 DreamStation CPAP Pro, EE EEX400S1593/42 DreamStation CPAP Pro, ES ESX400S1593/42 DreamStation CPAP Pro, EU EUX400S1593/42 DreamStation CPAP Pro, FR FRX400S1493/42 DreamStation CPAP Pro, GB GBX400S1593/42 DreamStation CPAP Pro, INTL INX400S1593/42 DreamStation CPAP Pro, IT ITX400S1593/42 DreamStation CPAP Pro, Latin America LAX400S1593/42 DreamStation CPAP Pro, PW, 22mm PWX401S1593/42 DreamStation CPAP Pro, TR TRX400S1593/42 DreamStation CPAP Pro, Ukraine UAX400S1593/42 DreamStation CPAP w/ Humid/HT, LA LAX200T1593/42 DreamStation CPAP w/AHI ES ESX201S1593/42 DreamStation CPAP w/AHI, BL BLX201S1593/42 DreamStation CPAP w/AHI/Cell ES ESX201S15C93/42 DreamStation CPAP w/AHI/Cell, BL BLX201S15C93/42 DREAMSTATION CPAP W/HUMID,LA,Cell Modem, LAX200H15C93/42 DREAMSTATION CPAP W/HUMIDIFIER, Cell Mod ARX200H15C93/42 DreamStation CPAP w/Humidifier, w/Heated Tube, INTL INX200T1593/42 DreamStation CPAP with Humidifier, AR ARX200H1593/42 DreamStation CPAP with Humidifier, BL BLX200H1593/42 DreamStation CPAP with Humidifier, EU EUX200H1593/42 DreamStation CPAP with Humidifier, INTL INX200H1593/42 DreamStation CPAP with Humidifier, Latin America LAX200H1593/42 DreamStation CPAP with Humidifier, TR TRX200H1593/42 DreamStation CPAP, AR ARX200S1593/42 DreamStation CPAP, BL BLX200S1593/42 DreamStation CPAP, ES ESX200S1593/42 DreamStation CPAP, EU EUX200S1593/42 DreamStation CPAP, INTL INX200S1593/42 DreamStation CPAP, IT ITX200S1593/42 DreamStation CPAP, LA LAX200S1593/42 DreamStation CPAP, TR TRX200S1593/42 DreamStation Expert w/Humidifier, w/WiFi, FR FRX501H14W93/42 DreamStation Expert, FR FRX501S1493/42 DreamStation Flow Generator Cover 112816393/42 DreamStation REMstar Auto Rental RDEX500S1393/42 DreamStation REMstar Pro Rental RDEX400S1393/42 DreamStation S/T 30 w/Heated Humidifier, EE EEX1030H2293/42 DreamStation S/T 30 w/HTD Humid, No BT, AAM, EU EUX1030H1993/42 DreamStation ST 30 AAM, ND NDX1030S1593/42 DreamStation ST 30 with Heated Humidifier, AAM, ND NDX1030H1593/42 DreamStation ST 30 with Heated Humidifier, ND NDX1030H2093/42 DreamStation ST 30, ND NDX1030S2093/42 DreamStation Travel Kit, 65W P/S, AU AU112013593/42 DreamStation Travel Kit, 65W P/S, EU93/42 DreamStation Travel Kit, 65W P/S, IN IN112013593/42 DreamStation, BiPAP AutoSV with Humidifier, DE DEX900H1393/42 DreamStation, BiPAP AutoSV with Humidifier, EE EEX900H1593/42 DreamStation, BiPAP AutoSV with Humidifier, EU EUX900H1593/42 DreamStation, BiPAP AutoSV with Humidifier, GB GBX900H1593/42 DreamStation, BiPAP AutoSV with Humidifier, IT ITX900H1593/42 DreamStation, BiPAP S/T30, FR FRX1030S1493/42 DREAMSTATIONAUTO BIPAP, AR+ Cell Modem, ARX700S15C93/42 DS2 Adv Auto CPAP w/Humid cell/BT, BL BLX520H15C93/42 DS2 Adv CPAP w/Humid cell/BT, BL BLX420H15C93/42 DS2 Auto CPAP w/Humid cell/BT, DE DEX420H13C93/42 DS2 CPAP w/Humid cell/BT, ES ESX410H15C93/42 DS2 CPAP w/Humid cell/BT, IT ITX410H15C93/42 DS2Adv Auto CPAP w/Humid BT only, EU EUX520H1593/42 DS2Adv Auto CPAP w/Humid cell/BT, EU EUX520H15C93/42 DS2Adv Auto CPAP w/Humid cell/BT, GB GBX520H15C93/42 DS2Adv Auto CPAP w/Humid/HT cell/BT, ND NDX520T15C93/42 DS2Adv CPAP w/Humid cell/BT, EE EEX420H15C93/42 DS2Adv CPAP w/Humid cell/BT, IT ITX420H15C93/42 Dual Limb Active Exhalation Valve 113211093/42 Dual Limb Active Exhalation Valve 113943693/42 External Flow Sensor Cable 113459293/42 External Flow Sensor w/Cable, Adult/Ped 113210693/42 External Flow Sensor w/Cable,Ped/Infant 113210793/42 External Flow Sensor, Adult/Ped 113471193/42 External Flow Sensor, Ped/Infant 113471293/42 FEP Circuit S/A w/Filter – INTL Single Use Filtered Exhalation Port Circuit93/42 FEP Circuit S/A W/O Filters 106921193/42 Filtered Exhalation Port (FEP) FPH 150PK 114061393/42 Filtered Exhalation Port (FEP) S/A, 150PK 113466493/42 Flex Trach Adapt 15cm,22M/15F-15 10pk 107386393/42 Flex Trach Adapt 15cm,22M/15F-22F10pk 107390293/42 Flex Trach Adapter 15cm, 22M/15F-15 20 pk 107390393/42 Garbin Evo, Linde93/42 HOSE,22mm-18IN,NON-AUTOCLAV93/42 Kit, Active Exhalation Valve UPB 107545993/42 LifeVentEVO293/42 MPV Replacement Straw Kit 111884093/42 MPV Support System Kit 110286293/42 Oxygen O2 Enrichment Attachment 02 Enrichment Attachmnt Sngl93/42 Pediatric Invasive Passive Disposable Non-Heated Circuit 106944593/42 Pressure Valve, 5 Pack 30242393/42 REMstar Pro C-Flex+, System One 60 Series, DE REMstar System (60 Series)93/42 Rental, DreamStation ST30, GB RGBX1030S2093/42 Single Use Filtered Exhalation Port Circuit CKT FILTER DEP W/FEP 10PK INTL93/42 Trilogy 100 Ventilator,Germany-BT-RENT Trilogy 100, Trilogy EC93/42 Trilogy 200 Ventilator, Intl-Recert93/42 Trilogy Active Flow Exhalation Circuit, Pediatric 106883893/42 Trilogy Active with PAP Exhalation Circuit, Adult 105206493/42 Trilogy Active with PAP Exhalation Circuit, Pediatric 105206593/42 Trilogy EV300, Benelux93/42 Trilogy EV300, Eastern Europe93/42 Trilogy EV300, EU93/42 Trilogy EV300, EU (Non-BT)93/42 Trilogy EV300, France93/42 Trilogy EV300, Germany93/42 Trilogy EV300, Great Britain93/42 Trilogy EV300, INT w/ OBM93/42 Trilogy EV300, INTL93/42 Trilogy EV300, Italy93/42 Trilogy EV300, Nordics93/42 Trilogy EV300, Spain93/42 Trilogy EV300, Turkey93/42 Trilogy Evo O2, Benelux93/42 Trilogy Evo O2, Eastern Europe93/42 Trilogy Evo O2, France93/42 Trilogy Evo O2, Germany93/42 Trilogy Evo O2, Great Britain93/42 Trilogy Evo O2, Iberia93/42 Trilogy Evo O2, Italy93/42 Trilogy Evo O2, Nordics93/42 Trilogy Evo, Benelux93/42 Trilogy Evo, Eastern Europe93/42 Trilogy Evo, EU93/42 Trilogy Evo, EU (Non-BT)93/42 Trilogy Evo, France93/42 Trilogy Evo, Germany93/42 Trilogy Evo, Great Britain93/42 Trilogy Evo, Iberia93/42 Trilogy Evo, INT93/42 Trilogy Evo, International93/42 Trilogy Evo, International (Non-BT)93/42 Trilogy Evo, Italy93/42 Trilogy Evo, Latin America LA2110X15B93/42 Trilogy Evo, Nordics93/42 Trilogy Evo, O2, EU93/42 Trilogy Evo, O2, EU (Non-BT)93/42 Trilogy Evo, O2, INT93/42 Trilogy Evo, O2, International93/42 Trilogy Evo, O2, International (Non-BT)93/42 Trilogy Evo, O2, Latin America LA2100X15B93/42 Trilogy Evo, O2, Turkey TR2100X15B93/42 Trilogy Evo, Turkey TR2110X15B93/42 Trilogy Passive Exhalation Circuit, Adult 105206693/42 Trilogy Passive Exhalation Circuit, Pediatric 105212793/42 Trilogy, Mouthpiece Ventilation Disposable Circuit 110286693/42 Trilogy, Mouthpiece Ventilation Disposable Circuit 110286993/42 Trilovy EV300, O2 Australia AU2110X15B93/42 Whisper Swivel II Packaged93/42 (10) BiPAP Disposable Humidifier Tubing 36 IN (91cm)93/42 (no longer marketed) (10) Disposable Proximal Pressure Line Assembly93/42 (no longer marketed) BiPAP A30 Ventilator France93/42 (no longer marketed) BiPAP A30 Ventilator Private Label, INTL93/42 (no longer marketed) BiPAP A30 Ventilator, INTL93/42 (no longer marketed) BiPAP A30, International-Rental2 refs93/42 (no longer marketed) BiPAP A30, Linde Eolus 3093/42 (no longer marketed) BiPAP A30, Medicair Respicomfort93/42 (no longer marketed) BiPAP A30, Silver Series- RENTAL93/42 (no longer marketed) BiPAP A30, Vitalaire Vitalvent 3093/42 (no longer marketed) BiPAP A30-S Silver Series93/42 (no longer marketed) BiPAP A30-S Silver Series - RENTAL93/42 (no longer marketed) BiPAP A40 Silver Series BiPAP A40 Ventilator93/42 (no longer marketed) BiPAP A40 Ventilator Private Label, INTL93/42 (no longer marketed) BiPAP A40 Ventilator, FR93/42 (no longer marketed) BiPAP A40 Ventilator, INTL93/42 (no longer marketed) BiPAP A40 Ventilator, IT93/42 (no longer marketed) BiPAP A40, International-Rental93/42 (no longer marketed) BiPAP A40, Silver Series - RENTAL93/42 (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-Flex93/42 (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 One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE 60 Series, INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, INT BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV w/ HT Humid, 60 Series, 30cm INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV, w/Humid 60 Series, 30cm, INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV,60 Srs, 30cm, DE Rental BiPAP autoSV Advanced System One93/42 (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) 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 Accessories93/42 (no longer marketed) Disposable Tubing 6 IN (15.2) QTY:10 BiPAP Disposable Circuits and Accessories93/42 (no longer marketed) Dorma 100 IT93/42 (no longer marketed) Dorma 100 with Humidifier, INTL93/42 (no longer marketed) Dorma 100, INTL93/42 (no longer marketed) Dorma 100, Oxigen Salud93/42 (no longer marketed) Dorma 200 with Humidifier, FR93/42 (no longer marketed) Dorma 200 with SD Card, IT, con scheda SD, IT93/42 (no longer marketed) Dorma 200, FR93/42 (no longer marketed) Dorma 200, LD93/42 (no longer marketed) Dorma 200, with Humidifier, LD93/42 (no longer marketed) Dorma 400 w/Humid, DE93/42 (no longer marketed) Dorma 400, DE- RENTAL93/42 (no longer marketed) Dorma 500 Auto, IN93/42 (no longer marketed) Dorma 500 Auto, INTL93/42 (no longer marketed) Dorma 500 Auto, TR93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, IN93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, INTL93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, TR93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/BT only, EU93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/BT only, IT93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/Cell/BT, ND93/42 (no longer marketed) DreamStation 2 Auto CPAP Humidifier/Cell/Bluetooth, EU DreamStation 2 CPAP/Auto CPAP93/42 (no longer marketed) DreamStation 2 CPAP Humid/BT only, EU93/42 (no longer marketed) DreamStation 2 CPAP Humid/BT only, IT93/42 (no longer marketed) Garbin Plus Ventilator, Bluetooth, INTL Trilogy 20093/42 (no longer marketed) Garbin Plus Ventilator, International93/42 (no longer marketed) Garbin Ventilator — Bluetooth93/42 (no longer marketed) Garbin Ventilator, Bluetooth, DE Trilogy 100, Trilogy EC93/42 (no longer marketed) Garbin Ventilator, DE Trilogy 100, Trilogy EC93/42 (no longer marketed) Garbin Ventilator, International Garbin Plus93/42 (no longer marketed) Humidifier Tubing, 36 inch (91 cm) BiPAP Disposable Circuits and Accessories; Trilogy93/42 (no longer marketed) LifeVent200 Ventilator, Sapio, Bluetooth Trilogy 20093/42 (no longer marketed) Portable electric ventilator BiPAP A3093/42 (no longer marketed) Recert Trilogy 100 Ventilator,INTl - BT Trilogy 100, Trilogy EC93/42 (no longer marketed) Recert-Trilogy 100 Vent,Germany -BT Trilogy 100, Trilogy EC93/42 (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 System93/42 (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 INT93/42 (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, INTL93/42 (no longer marketed) REMstar SE with HUMIDIFIER, with SD Slot, INTL93/42 (no longer marketed) System One, Heated Tube System One Heated Humidifier SYS1HT1593/42 (no longer marketed) Trilogy 100 Ventilator, Germany Trilogy100 Ventilator Germany93/42 (no longer marketed) Trilogy 100 Ventilator, INTL — Bluetooth93/42 (no longer marketed) Trilogy 100 Ventilator, INTL — Bluetooth Trilogy 100, Garbin93/42 (no longer marketed) Trilogy 100 Ventilator, INTL-BT-RENT Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy 100 Ventilator, Italy - BT93/42 (no longer marketed) Trilogy 20093/42 (no longer marketed) Trilogy 200 Ventilator Germany Bluetooth93/42 (no longer marketed) Trilogy 200 Ventilator, AERIS 200-BT93/42 (no longer marketed) Trilogy 200 Ventilator, Germany93/42 (no longer marketed) Trilogy 200 Ventilator, Germany-Recert93/42 (no longer marketed) Trilogy 200 Ventilator, Germany-Rental93/42 (no longer marketed) Trilogy 200 Ventilator, International93/42 (no longer marketed) Trilogy 200 Ventilator, INTL-Bluetooth93/42 (no longer marketed) Trilogy 200 Ventilator, Intl-Rental93/42 (no longer marketed) Trilogy 200 Ventilator, Italy- BT93/42 (no longer marketed) Trilogy 202 Ventilator Germany Trilogy 202/O293/42 (no longer marketed) Trilogy 202 Ventilator International Trilogy 202/O293/42 (no longer marketed) Trilogy 202 Ventilator,Intl-RENTAL Trilogy 202/O293/42 (no longer marketed) Trilogy Evo, Medic Air93/42 (no longer marketed) Trilogy100 Ventilator, Bluetooth, Germany Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Bluetooth, Italy Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Germany Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Germany-Recert Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Germany-Rental Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, International Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Intl-Recert Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Intl-Rental Trilogy 100, Trilogy EC93/42 (no longer marketed)	IIa, IIb 93/42	eudamed@philips.com 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-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA-2, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000AA-2, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000J, PCS-EU93/42 147 others Avant Pulse Oximeter System MODEL 9600, 8000SL, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000SL-3, PCS-US93/42 Avant Pulse Oximeter System MODEL 9600, 8000SM, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000SM-3, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8000SS-3, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, 8008J, PCS-EU93/42 Avant Pulse Oximeter System MODEL 9600, PULSE OXIMETER HC93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000AA-3, PCS-US93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000SL-3, PCS-US93/42 Avant Pulse Oximeter System with Waveform MODEL 9700, 8000SM-3, PCS-US93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000AA-3, PCS-EU93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000AA-3, PCS-US93/42 Avant® 9600 Pulse Oximeter MODEL 9600, 8000SM-3, PCS-UK93/42 Fiber Optic Pulse Oximeter MODEL 7500FO, PCS-JP93/42 Fiber Optic Pulse Oximeter MODEL 7500FO, PULSE OXIMETER, INMETRO93/42 Fingertip Pulse Oximeter MODEL 9590, OXIMETER - BLACK, INMETRO93/42 FINGERTIP PULSE OXIMETER with 9590 BLUE, OXIMETER MODEL 9590 BLUE, OXIMETER93/42 FINGERTIP PULSE OXIMETER with 9590 RED, OXIMETER MODEL 9590 RED, OXIMETER93/42 FINGERTIP PULSE OXIMETER, MODEL 9590 BLK, OXIMETER93/42 Flexiwrap Adhesive Strips 70276, MODEL 8000JFW ADULT FLEXW DISP93/42 LP XPOD 22370, XPOD LP - 8000SM SENSOR SET93/42 LP XPOD 22380, XPOD LP - 7000A SENSOR SET93/42 LP XPOD 36944, XPOD LP - 8000SM-3M SENSOR SET93/42 Model 2500 PKG ASSY, 2500, CHINA93/42 MODEL 2500, PALMSAT HANDHELD OXIMETER93/42 MODEL 3011LP XPOD, OXIMETER DF1 2M W/O CONN93/42 MODEL 3011LP XPOD, OXIMETER DF1 W/O CONN93/42 MODEL 3012LP, LP XPOD93/42 MODEL 3017LP XPOD, OXIMETER DF7 W/OUT CONN93/42 MODEL 3150SC, WRIST-OX2 USB COMM CABLE93/42 Model 3231 USB OEM External Pulse Oximeter93/42 MODEL 7500, 8000SL, PCS-USPulse Oximeter System93/42 Model 9550 Onyx II Fingertip Pulse Oximeter System 6515-01-535-2728, OXIMETER, PULSE, FINGER W/CASE93/42 MODEL 9590, OXIMETER BLUE93/42 MODEL 9590, OXIMETER RED93/42 MODEL LP XPOD, ALICE NIGHTONE, NONIN SPO2 CAB93/42 MODEL LP XPOD, NONIN, SPO2 CABLE, ALICE93/42 MODEL X-100H, HUB93/42 MODEL X-100HH, HUB HOLSTER93/42 Multi-Sensing Oximetry Signal Processor MODEL 3500SP, DEVELOPMENT KIT93/42 NoninConnect Elite Finger Pulse Oximeter MODEL 3240, NONINCONNECT ELITE93/42 OEM External Pulse Oximeter MODEL 323193/42 OEM External Wireless Pulse Oximeter MODEL 3230, V2.7 AU/NZ93/42 OEM External Wireless Pulse Oximeter PKG ASSY, 3230, CONTINUA93/42 Onyx II Fingertip Pulse Oximeter MODEL 9550, PULSE OXIMETER93/42 Onyx® Vantage 9590 Fingertip Pulse Oximeter MODEL 9590, OXIMETER BLACK93/42 Onyx® Vantage 9590 Fingertip Pulse Oximeter MODEL 9590, OXIMETER PURPLE93/42 PalmSAT Charger MODEL 2500C, PCS-JP93/42 PalmSAT Charger MODEL 2500C, PULSE OXIMETER CHARGER, INMETRO93/42 PALMSAT HANDHELD OXIMETER MODEL 2500, 8000Q293/42 PALMSAT HANDHELD OXIMETER MODEL 2500A CFG, PULSE OXIMETER W/ALARMS93/42 PALMSAT HANDHELD OXIMETER MODEL 2500A, PULSE OXIMETER W/ALARMS93/42 PALMSAT HANDHELD OXIMETER with 8000J sensor MODEL 2500, 8000J93/42 PALMSAT HANDHELD OXIMETER with 8001J sensor MODEL 2500, 8001J93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AA-293/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AA-393/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AP93/42 PalmSat Pulse Oximeter System MODEL 2500, 8000AP-393/42 PalmSat Pulse Oximeter System MODEL 2500, 8000J-393/42 PalmSat Pulse Oximeter System MODEL 2500, 8000SL-393/42 PalmSat Pulse Oximeter System MODEL 2500, PALMSAT HANDHELD OXIMETER CONFIGUREABLE93/42 PalmSat Pulse Oximeter System MODEL 2500A INMETRO, 8000SM-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000AA-293/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000AP-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000J93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000Q293/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SL93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SL-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SS93/42 PalmSat Pulse Oximeter System MODEL 2500A, 8000SS-393/42 PalmSat Pulse Oximeter System MODEL 2500A, 8008J93/42 Pulse Oximeter System MODEL 2500, 8000SS-393/42 Pulse Oximeter System MODEL 7500 INMETRO, 8000SM-393/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000AA, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000AA-2, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000AA-3, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000AA-3M, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000AP, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000AP, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000AP-3, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000J, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000Q2, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000SL, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SL-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000SM, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8000SM-3, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000SS, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SS, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-AU93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8000SS-3, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-UK93/42 Pulse Oximeter System MODEL 7500, 8001J, PCS-US93/42 Pulse Oximeter System MODEL 7500, 8008J, PCS-EU93/42 Pulse Oximeter System MODEL 7500, 8008J, PCS-US93/42 Pulse Oximeter System MODEL 7500, NO SENSOR, PCS-AU93/42 Pulse Oximeter System MODEL 7500, PULSE OXIMETER HC93/42 Pulse Oximeter with Waveform MODEL 9700, 8000AA, PCS-EU93/42 SenSmart X-100 MODEL X-100SP-1, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-2, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-3, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-4, SENSMART SIGNAL PROCESSOR93/42 SenSmart X-100 MODEL X-100SP-6, SENSMART SIGNAL PROCESSOR93/42 Universal Oximetry System MODEL X-100, INT, PCS-EU, ENG93/42 Universal Oximetry System MODEL X-100, INT, PCS-EU, NONE93/42 Universal Oximetry System MODEL X-100, INT, PCS-UK, NONE93/42 Universal Oximetry System MODEL X-100, INT, PCS-UK, NONE, ENG93/42 Universal Oximetry System MODEL X-100, INT, PCS-US, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-EU, NONE, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-UK, NONE, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-US, JAPAN, ENG93/42 Universal Oximetry System MODEL X-100, LONG, PCS-US, NONE, ENG93/42 Universal Oximetry System PKG ASSY, X-100SP-1/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-2/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-3/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-4/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-5/INT-10093/42 Universal Oximetry System PKG ASSY, X-100SP-6/INT-10093/42 Vital Signs Monitor Capnography/Pulse Oximeter MODEL LS1-9R, 8000AA-3, US93/42 Wireless Handheld Multi-Parameter System (H500) MODEL CO-PILOT93/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000AA-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000J-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SL-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SM-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 BLE, 8000SS-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000AA-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000J-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000SL-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150 USB, 8000SM-WO293/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE, PACK, NOX93/42 Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE, PHILIPS93/42 Wrist-Worn Pulse Oximeter MODEL 3150SC, WRIST-OX2 USB COMM CABLE, PHILIPS93/42 Wrist-Worn Pulse Oximeter MODEL 3150USB, 8000SS-WO293/42 WristOx2® Model 3150 MODEL 3150WB, PKG ASSY, 3150WB, WRISTBAND93/42 WristOx2® Model 3150 with Bluetooth® Low Energy Wrist-Worn Pulse Oximeter MODEL 3150, WRIST-OX2, BLE93/42	IIb 93/42	regulatory@nonin.com EUDAMED record Report an error
BNOS MediTECH EU representative : Medical Device Management Ltd (Ireland)	United Kingdom (ex Northern Ireland)	AC Adv NL01 45 Hayer Microvent93/42 AC Adv World Microvent - 1M AGA Hose93/42 AO Adv World 45 Schrader Microvent93/42 microVENT Advanced European Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT Advanced European Adult and Child Resuscitator - AGA fitting, white hose93/42 126 others microVENT Advanced European Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT Advanced European Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Advanced European Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Advanced European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Advanced European Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Classic, Advanced, Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator -DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator, AFNOR French fitting, White Hose.93/42 microVENT Classic, Standard - AGA fitting, white hose93/42 microVENT Classic, Standard - DIN (Hayer) fitting, white hose93/42 microVENT Classic, Standard - JIS fitting, green hose93/42 microVENT Classic, Standard Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT Classic, Standard Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT Classic, Standard Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT Classic, Standard Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Classic, Standard Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Classic, Standard Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Classic, Standard Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT Classic, Standard, - BS fitting (Schrader probe), white hose93/42 microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT CPR Resuscitator, Standard, Adult and Child - AFNOR French fitting, white hose93/42 microVENT CPR Resuscitator, Standard, Adult and Child - AGA fitting, white hose93/42 microVENT CPR Resuscitator, Standard, Adult and Child - BS fitting (Schrader probe), white hose93/42 microVENT CPR Resuscitator, Standard, Adult and Child - DIN (Hayer) fitting, white hose93/42 microVENT CPR Resuscitator, Standard, Adult and Child - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT CPR Resuscitator, Standard, Adult and Child - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT CPR Resuscitator, Standard, Adult and Child - JIS fitting, green hose93/42 microVENT CPR Resuscitator, Standard, Adult and Child - SIS Australian fitting, white hose93/42 microVENT CPR Resuscitator, Standard, Adult and Child - UNIFOR (Italian) Fitting, White Hose93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - AFNOR French fitting, white hose93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - AGA fitting, white hose93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief2 refs93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator - JIS fitting, green hose93/42 microVENT Industrial, Advanced, 'European' Adult Resuscitator -SIS Australian fitting, white hose93/42 Microvent Industrial, Advanced, Adult Only, BS Probe93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - AFNOR French fitting, white hose93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - AGA fitting, white hose93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - JIS fitting, green hose93/42 microVENT Industrial, Standard, 'European' Adult Resuscitator - SIS Australian fitting, white hose93/42 Microvent Lithuania Spec, A/C Adv, AGA Hose, Stretcher Bracket93/42 microVENT Responder Resuscitator, Adult and Child - AFNOR French fitting, white hose93/42 microVENT Responder Resuscitator, Adult and Child - AGA fitting, white hose93/42 microVENT Responder Resuscitator, Adult and Child - BS fitting (Schrader probe), white hose93/42 microVENT Responder Resuscitator, Adult and Child - DIN (Hayer) fitting, white hose93/42 microVENT Responder Resuscitator, Adult and Child - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Responder Resuscitator, Adult and Child - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Responder Resuscitator, Adult and Child - JIS fitting, green hose93/42 microVENT Responder Resuscitator, Adult and Child - SIS Australian fitting, white hose93/42 microVENT Standard European Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT Standard European Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT Standard European Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT Standard European Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT Standard European Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT Standard European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT Standard European Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - JIS fitting, green hose93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - AFNOR French fitting, white hose93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - AGA fitting, white hose93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT UtilityVenT, Advanced, Adult Resuscitator - SIS Australian fitting, white hose93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - AFNOR French fitting, white hose93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - AGA fitting, white hose93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - JIS fitting, green hose93/42 microVENT UtilityVenT, Standard, Adult Resuscitator - SIS Australian fitting, white hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT World, Advanced, Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - SIS Australian fitting, white hose93/42 microVENT World, Advanced, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White Hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - SIS Australian fitting, white hose93/42 microVENT World, Advanced, Airmix, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White hose93/42 Microvent World, Airmix, Advanced 3M Hose AGA Probe93/42 microVENT World, Standard, Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT World, Standard, Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT World, Standard, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT World, Standard, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT World, Standard, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT World, Standard, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT World, Standard, Adult and Child Resuscitator - SIS Australian fitting, white hose93/42 microVENT World, Standard, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White Hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - AGA fitting, white hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - JIS fitting, green hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - SIS Australian fitting, white hose93/42 microVENT World, Standard, Airmix, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White Hose93/42 Mircovent microVENT World, Standard, Adult and Child Resuscitator - JIS fitting, green hose93/42	IIa 93/42	Website sales@meditech.uk.com EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	Anesthesia Machine A5, A5A, A73 refs Anesthesia Machine AX-9003 refs Anesthesia machine X83 refs Central Monitoring System Software eCenter-OB COMEN Telemetry CT303 refs 104 others Defibrillator monitor S8 Emergency and Transport Ventilator EV203 refs Emergency and Transport Ventilator EV3,EV53 refs Emergency and Transport Ventilator V13 refs Fetal & Maternal Monitor STAR500093/42 Fetal & Maternal Monitor STAR5000A93/42 Fetal & Maternal Monitor STAR5000B93/42 Fetal & Maternal Monitor STAR5000C93/42 Fetal & Maternal Monitor STAR5000D93/42 Fetal & Maternal Monitor STAR5000E93/42 Fetal & Maternal Monitor STAR5000F93/42 Fetal & Maternal Monitor STAR5000H93/42 Infant Phototherapy Equipment BL703 refs Infusion Pump ME60093/42 Infusion Pump ME6602 refs Infusion Pump ME9002 refs Infusion Pump ME900-L2 refs Infusion workstation M20093/42 Infusion Workstation System MX89002 refs Multi-parameter Patient Monitor C100A93/42 Multi-parameter patient monitor C302 refs Multi-parameter Patient Monitor C5093/42 Multi-parameter Patient Monitor C50093/42 Multi-parameter Patient Monitor C7093/42 Multi-parameter Patient Monitor C70A93/42 Multi-parameter Patient Monitor C8093/42 Multi-parameter Patient Monitor C80093/42 Multi-parameter Patient Monitor C8693/42 Multi-parameter Patient Monitor C86093/42 Multi-parameter Patient Monitor C9093/42 Multi-parameter Patient Monitor C90A93/42 Multi-parameter Patient Monitor Datalys 75093/42 Multi-parameter Patient Monitor Datalys 77093/42 Multi-parameter Patient Monitor Datalys 78093/42 Multi-parameter Patient Monitor Datalys 79093/42 Multi-parameter Patient Monitor K13 refs Multi-parameter Patient Monitor K123 refs Multi-parameter Patient Monitor K12A pro93/42 Multi-parameter Patient Monitor K15 pro93/42 Multi-parameter Patient Monitor K18 pro93/42 Multi-parameter Patient Monitor K18A pro93/42 Multi-parameter Patient Monitor K18Pro3 refs Multi-parameter Patient Monitor K222 refs Multi-parameter Patient Monitor K22 pro93/42 Multi-parameter Patient Monitor K22A pro93/42 Multi-parameter patient monitor MR-M80T3 refs Multi-parameter Patient Monitor N103 refs Multi-parameter Patient Monitor NC1093/42 Multi-parameter Patient Monitor NC10A93/42 Multi-parameter Patient Monitor NC1293/42 Multi-parameter Patient Monitor NC12A93/42 Multi-parameter Patient Monitor NC1993/42 Multi-parameter Patient Monitor NC19A93/42 Multi-parameter Patient Monitor NC893/42 Multi-parameter Patient Monitor NC8A93/42 Multi-parameter patient monitor ND1503 refs Multi-parameter patient monitor ND15S3 refs Multi-parameter Patient Monitor OPUS i1093/42 Multi-parameter Patient Monitor OPUS i10 Expert93/42 Multi-parameter Patient Monitor OPUS i1293/42 Multi-parameter Patient Monitor OPUS i12 pro93/42 Multi-parameter Patient Monitor OPUS i1593/42 Multi-parameter Patient Monitor OPUS i893/42 Multi-parameter Patient Monitor STAR800093/42 Multi-parameter Patient Monitor STAR8000A93/42 Multi-parameter Patient Monitor STAR8000B93/42 Multi-parameter Patient Monitor STAR8000C93/42 Multi-parameter Patient Monitor STAR8000D93/42 Multi-parameter Patient Monitor STAR8000E93/42 Multi-parameter Patient Monitor STAR8000F93/42 Multi-parameter Patient Monitor STAR8000H93/42 Multi-parameter Patient Monitor VC1002 refs Multi-parameter Patient Monitor VC800Pro3 refs Neonatal and Pediatric Ventilators NV103 refs Neonatal and Pediatric Ventilators VN8S HFO3 refs Neonatal Ventilator NV63 refs NIBP Cuff CM-M04-0013 refs Specialized Cardiovascular Monitor C10093/42 Specialized Cardiovascular Monitor C100B93/42 Specialized Fetal & Maternal Monitor C104 refs Specialized Fetal & Maternal Monitor C1193/42 Specialized Fetal & Maternal Monitor C2093/42 Specialized Fetal & Maternal Monitor C2193/42 Specialized Fetal & Maternal Monitor C2693/42 Specialized Fetal & Maternal Monitor C2993/42 Specialized Fetal&Maternal Monitor CF3/CF3A/CF30/CF30A/CF3 R/CF3A R/CF30 R/CF30A R3 refs Specialized Neonatal Monitor C6093/42 Specialized Neonatal Monitor C6693/42 Specialized Neonatal Monitor C6893/42 Specialized Neonatal Monitor Datalys 76093/42 Specialized Neonatal Monitor K603 refs Syringe Pump M200A93/42 Syringe Pump M2602 refs Syringe Pump M30093/42 Syringe Pump M50093/42 Syringe Pump M500A2 refs Syringe Pump M8003 refs Syringe Pump M800-L2 refs Ventilator V23 refs Ventilator V33 refs Ventilator V83 refs Vital Signs Monitor NC53 refs Vital Signs Monitor NC73 refs Product name: Emergency and Transport Ventilator EV22 refs (no longer marketed)	I, IIa, IIb, III MDR, 93/42	EUDAMED record Report an error
A&D FDA EU representative : Emergo Europe B.V. (Netherlands)	Japan	A0924 CUF-KS-LL A0925 CUF-KS-LA A0927 CUF-KS-SA A0928 CUF-KS-SS A0978 CUF-KS-A 85 others CUF-D-LA-ISO CUF-D-MA-ISO CUF-D-SA-ISO CUF-F-A CUF-F-A-ISO CUF-F-LA CUF-F-SA CUF-F-SL CUF-G-A CUF-G-A-ISO CUF-I CUF-I-ISO CUF-KS-A CUF-KS-LA CUF-KS-LL CUF-KS-SA CUF-KS-SS CUF-KW-A CUF-KW-LA CUF-KW-LL CUF-KW-SA CUF-KW-SS SENDO ADVANCE 22 refs SENDO ADVANCE 32 refs SENDO SMART 22 refs SENDOCUF-F-A SENDOCUF-F-LA TM-24402 refs TM-24412 refs TM-2441L-EL16 TM-2657P2 refs TM-2657WP TM-CF202A TM-CF202D TM-CF302A TM-CF302D TM-CF306A TM-CF402A TM-CF402D TM-CF502A TM-CF502D TM-CF802A TM-CF802D UA-10202 refs UA-1020-W2 refs UA-1200BLE93/42 UA-601 Eco UA-602 Eco Plus UA-605 Vital UA-606 Vital Plus UA-6112 refs UA-611Plus2 refs UA-65193/42 UA-651BLE2 refs UA-651Plus3 refs UA-651SL3 refs UA-651SL Plus2 refs UA-656BLE2 refs UA-7042 refs UA-767F2 refs UA-767S3 refs UA-767S-W2 refs UB-5253 refs UB-5332 refs UB-5432 refs UM-1023 refs UM-2112 refs UM-212BLE2 refs UM-AURS2M1KEC UM-AURS2M1KJC UM-AURS4K1KEC UM-LARS2M1KEC UM-LARS2M1KJC UM-LARS4K1KEC UM-LLRS2M1KEC UM-LLRS2M1KJC UM-LLRS4K1KEC UM-SARS2M1KEC UM-SARS2M1KJC UM-SARS4K1KEC UM-SSRS2M1KEC UM-SSRS2M1KJC UM-SSRS4K1KEC UM-WRRS2M1KEC UM-WRRS2M1KJC	I, IIa MDR, 93/42	EUDAMED record Report an error
Omron FDA EU representative : OMRON Healthcare Europe B.V. (Netherlands)	Japan	CM (HEM-CR24-RU) CM2 Medium Cuff (HEM-CR24-E) Complete (HEM-7440T1-FLE) CS2 Small Cuff (HEM-CS24-E) CUFF HOSE No.1 (3.5m) 87 others CUFF HOSE No.2 (1.5m) Easy Cuff HEM-RML31 (HEM-RML31-E) EVOLV (HEM-7600T-E) GS CUFF L (HXA-GCUFF-LLB) GS CUFF M (HXA-GCUFF-MLB) GS CUFF S (HXA-GCUFF-SLB) GS CUFF SS (HXA-GCUFF-SSLB) GS CUFF XL (HXA-GCUFF-XLLB) GS CUFF2 L (HXA-GCFL-PBE) GS CUFF2 L (HXA-GCFL-PCE) GS CUFF2 M (HXA-GCFM-PBE) GS CUFF2 M (HXA-GCFM-PCE) GS CUFF2 S (HXA-GCFS-PBE) GS CUFF2 S (HXA-GCFS-PCE) GS CUFF2 SS (HXA-GCFSS-PBE) GS CUFF2 SS (HXA-GCFSS-PCE) GS CUFF2 XL (HXA-GCFXL-PBE) GS CUFF2 XL (HXA-GCFXL-PCE) HBP-1120 (HBP-1120-E(UK)) HBP-1120 (HBP-1120-E) HBP-1320 (HBP-1320-E(UK)) HBP-1320 (HBP-1320-E) HBP-1350-E HBP-1350-UK HeartGuide (HEM-6411T-MAE) HEM-7146T2-ESL HEM-7188-FLD HEM-7361T1-BS HEM-7530T-E3 HEM-907 (HEM-907-E7) HEM-CL19-PD HEM-CR19-PD HEM-CS19-PD HEM-CUCV-01E HEM-FL33-CE HEM-RML30 (HEM-RML30-E) HEM-RXL31 (HEM-RXL31-E) HEM-TUBE-100CE HEM-TUBE-130CE Intelli Cuff HEM-FL31 (HEM-FL31-E) Large size adult arm cuff (HEM-CL19) M1 Basic (HEM-7090-E) HEM-7188-E3 refs M1 Basic (HEM-7121J-AF) M1 Basic (HEM-7121J-LAF) M1 EasyFit (HEM-7920-FLE)2 refs M2 (HEM-7143-E) M2 Basic (HEM-7121J-E(C)) M2 Basic (HEM-7121J-E) M2 Comfort (HEM-7188-FLD6) M2 Essential (HEM-7188-E6)2 refs M2 Intelli IT (HEM-7143T1-EBK) M2 Intelli IT+ HEM-7146T2-EBK M2+ (HEM-7146-E) M3 (HEM-7154-E) M3 Comfort (HEM-7155-E(C)) M3 Comfort (HEM-7155-E) M3 Comfort AFib (HEM-7196-FLE) M7 Intelli IT AFib3 refs M300 (HEM-7121J-D) M300 Intelli IT (HEM-7143T1-D) M4 Intelli IT (HEM-7155T-EBK) M400 Comfort (HEM-7155-D) M400 Intelli IT (HEM-7155T-D) M500 Intelli IT (HEM-7361T-D) M6 Comfort (HEM-7360-E) M7 Intelli IT (HEM-7361T-EBK) Medium size adult arm cuff (HEM-CR19) Multi-User Blood Pressure Monitor (2021382) (HEM-7154-BS) NightView (HEM-9601T-E3) RS1 (HEM-6160-E) RS2 (HEM-6161-D) RS2 (HEM-6161-E) RS3 Intelli IT (HEM-6161T-D) RS3 Intelli IT (HEM-6161T-E) RS4 (HEM-6181-D) RS4 (HEM-6181-E) RS7 Intelli IT (HEM-6232T-D) RS7 Intelli IT (HEM-6232T-E) Small size adult arm cuff (HEM-CS19) X2 Basic (HEM-7121J-EO) X2 Smart (HEM-7143T2-ESL) X3 Comfort (HEM-7155-EO) X4 Smart (HEM-7155T-ESL) X7 Smart (HEM-7361T-ESL) HEM-CR24 (no longer marketed) HEM-CS24 (no longer marketed) HEM-FL31 (no longer marketed) HEM-RML31-AP2 (no longer marketed)	I, IIa MDR	info_omronhealthcare@omron.com EUDAMED record Report an error
Urion FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other	China	Abintrax U81D93/42 ALphagoMed U60CH93/42 ALphagoMed U60EH93/42 AlphagoMed U80793/42 Alphamed U19M U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T3 refs 82 others ALPHAMED U60B2 refs93/42 ALPHAMED U60CH93/42 ALPHAMED U60E2 refs93/42 AlphaMed U60GH93/42 Alphamed U62GH93/42 ALPHAMED U62I93/42 AlphaMed U80793/42 ALPHAMED U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models3 refs ALPHAMED U80E2 refs93/42 ALPHAMED U80EH2 refs93/42 ALPHAMED U81K93/42 ALPHAMED U81RH93/42 ALPHAMED U81V2 refs93/42 Alphamed U81Y93/42 ALPHAMED U82RH93/42 ALPHAMED U82V93/42 ALPHAMED U82W93/42 ALPHAMED U83H93/42 AlphaMed U83Y93/42 AlphaMed U83Z93/42 ALPHAMED U85H93/42 ALPhamed U86E93/42 AlphaMed U86WH93/42 ALPHAMED U87E93/42 ALPhamed U90B93/42 Alphamed U90B Plus U90B, U90B Pro, U90B PIus, U90B Ultra, U90C, U90C Pro, U90C Plus, U90C Ultra3 refs AlphaMed U90E93/42 Alphamed U90F93/42 ANOVATOR U80793/42 Anriwell AW-301 U80EH93/42 Autonomie et Bien être U60EH93/42 autonomie et bien être U80H93/42 Axets U63I93/42 Axets U81V93/42 BP MeasureX U80EH93/42 BP MeterX U80N93/42 Ciśnieniomierz naramienny DIATHER Care U87E2 refs93/42 Dr.Mayer U60CH93/42 Dr.Mayer U80EH93/42 ELERA U81E93/42 Farmadosis U80R93/42 HeartiPro U80N93/42 HERTIPRO U80Y93/42 HUGO-MED U81E93/42 Jnx\|Med U80N93/42 JOOPHYS U80R93/42 L2N U80M93/42 L2N U81Q93/42 L2N U87E93/42 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, U60G3 refs Life Net U80EH93/42 Meds MEDICAL SOLUTIONS U81V93/42 Meds MEDICAL SOLUTIONS U90B93/42 misure U81D3 refs93/42 Misure U81RH2 refs93/42 Misure U82RH3 refs93/42 Misure U90B2 refs93/42 Novacardix U80EH93/42 NOVΛCARDIX U80EH93/42 ORAVA U82RH93/42 ORTHOVISIONS U61H93/42 promed U80LH93/42 PVS FIRST AID U80E93/42 Redcare U81M93/42 ROTOPATA U87E93/42 SANGOOL U63H93/42 sanitayaki U63I93/42 sanitayaki U81CH93/42 sanitayaki U81Q93/42 santecare U60E93/42 SDUNW U80Z93/42 SDUNW U81V93/42 SimplyMED+ U63I2 refs93/42 SimplyMED+ U80EH93/42 SimplyMED+ U82RH2 refs93/42 Stepcare U90B93/42 SUNALE U80C93/42 U80B93/42 U82V93/42 U82V, Elektroniczny ciśnienia NARAMIENNY, depan2 refs93/42 URION U80EH93/42 WADEO U61H93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Ritim Grup Tibbi Cihazlar Elektronik Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Aselsan Heartline AED-6515-8444-000193/42 Aselsan Heartline AED-6515-8444-000293/42 Aselsan Heartline AED-6515-8444-000393/42 Aselsan Heartline AED-6515-8444-000493/42 Aselsan Heartline AED-6515-8444-000593/42 75 others Aselsan Heartline AED-6515-8444-000693/42 Aselsan Heartline AED-6515-8444-000793/42 Aselsan Heartline AED-6515-8444-000893/42 Aselsan Heartline AED-6515-8444-000993/42 Aselsan Heartline AED-6515-8444-001093/42 Aselsan Heartline AED-6515-8444-001193/42 Aselsan Heartline AED-6515-8444-001293/42 Aselsan Heartline AED-6515-8444-001393/42 Aselsan Heartline AED-6515-8444-001493/42 Aselsan Heartline AED-6515-8444-001593/42 Aselsan Heartline AED-6515-8444-001693/42 Aselsan Heartline AED-6515-8444-001793/42 Aselsan Heartline AED-6515-8444-001893/42 Aselsan Heartline AED-6515-8444-001993/42 Aselsan Heartline AED-6515-8444-002093/42 Aselsan Heartline AED-6515-8444-002193/42 Aselsan Heartline AED-6515-8444-002293/42 Aselsan Heartline AED-6515-8444-002393/42 Aselsan Heartline AED-6515-8444-002493/42 Aselsan Heartline AED-6515-8444-002593/42 Aselsan Heartline AED-6515-8444-002693/42 Aselsan Heartline AED-6515-8444-002793/42 Aselsan Heartline AED-6515-8444-002893/42 Aselsan Heartline AED-6515-8444-002993/42 Aselsan Heartline AED-6515-8444-003093/42 Aselsan Heartline AED-6515-8444-003193/42 Aselsan Heartline AED-6515-8444-003293/42 Aselsan Heartline AED-6515-8444-003393/42 Aselsan Heartline AED-6515-8444-003493/42 Aselsan Heartline AED-6515-8444-003593/42 Aselsan Heartline AED-6515-8444-003693/42 Aselsan Heartline AED-6515-8444-003793/42 Aselsan Heartline AED-6515-8444-003893/42 Aselsan Heartline AED-6515-8444-003993/42 Aselsan Heartline AED-6515-8444-004093/42 Life Rhythm AED LR-0233-000193/42 Life Rhythm AED-LR-0233-000293/42 Life Rhythm AED-LR-0233-000393/42 Life Rhythm AED-LR-0233-000493/42 Life Rhythm AED-LR-0233-000593/42 Life Rhythm AED-LR-0233-000693/42 Life Rhythm AED-LR-0233-000793/42 Life Rhythm AED-LR-0233-000893/42 Life Rhythm AED-LR-0233-000993/42 Life Rhythm AED-LR-0233-001093/42 Life Rhythm AED-LR-0233-001193/42 Life Rhythm AED-LR-0233-001293/42 Life Rhythm AED-LR-0233-001393/42 Life Rhythm AED-LR-0233-001493/42 Life Rhythm AED-LR-0233-001593/42 Life Rhythm AED-LR-0233-001693/42 Life Rhythm AED-LR-0233-001793/42 Life Rhythm AED-LR-0233-001893/42 Life Rhythm AED-LR-0233-001993/42 Life Rhythm AED-LR-0233-002093/42 Life Rhythm AED-LR-0233-002193/42 Life Rhythm AED-LR-0233-002293/42 Life Rhythm AED-LR-0233-002393/42 Life Rhythm AED-LR-0233-002493/42 Life Rhythm AED-LR-0233-002593/42 Life Rhythm AED-LR-0233-002693/42 Life Rhythm AED-LR-0233-002793/42 Life Rhythm AED-LR-0233-002893/42 Life Rhythm AED-LR-0233-002993/42 Life Rhythm AED-LR-0233-003093/42 Life Rhythm AED-LR-0233-003193/42 Life Rhythm AED-LR-0233-003293/42 Life Rhythm AED-LR-0233-003393/42 Life Rhythm AED-LR-0233-003493/42 Life Rhythm AED-LR-0233-003593/42 Life Rhythm AED-LR-0233-003693/42 Life Rhythm AED-LR-0233-003793/42 Life Rhythm AED-LR-0233-003893/42 Life Rhythm AED-LR-0233-003993/42 Life Rhythm AED-LR-0233-004093/42	III 93/42	Website info@ritimport.com EUDAMED record Report an error
SLE EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	SLE6000 - (Device) SLE6000 Infant Ventilator93/42 SLE6000 - Croatia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Czech (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Denmark (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - France (Packaging) SLE6000 Infant Ventilator93/42 70 others SLE6000 - Germany (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Greece (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Hungary (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Italy (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Netherlands (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Norway (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Poland (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Portugal (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Romania (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Slovakia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Slovenia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Spain (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - Sweden (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 - United Kingdom (Packaging) SLE6000 Infant Ventilator93/42 SLE6000 uSpo2 Cable (Masimo SET)93/42 SLE6000C - (Device) SLE6000 Infant Ventilator93/42 SLE6000C - Croatia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Czech (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Denmark (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - France (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Germany (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Greece (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Hungary (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Italy (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Netherlands (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Norway (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Poland (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Portugal (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Romania (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Slovakia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Slovenia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Spain (Packaging) SLE6000 Infant Ventilator93/42 SLE6000C - Sweden (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - (Device) SLE6000 Infant Ventilator93/42 SLE6000H - Croatia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Czech (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Denmark (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - France (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Germany (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Greece (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Hungary (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Italy (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Netherlands (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Norway (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Poland (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Portugal (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Romania (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Slovakia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Slovenia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Spain (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - Sweden (Packaging) SLE6000 Infant Ventilator93/42 SLE6000H - United Kingdom (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - (Device) SLE6000 Infant Ventilator93/42 SLE6000N - Croatia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Czech (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Denmark (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - France (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Germany (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Greece (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Hungary (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Italy (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Netherlands (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Norway (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Poland (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Portugal (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Romania (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Slovakia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Slovenia (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Spain (Packaging) SLE6000 Infant Ventilator93/42 SLE6000N - Sweden (Packaging) SLE6000 Infant Ventilator93/42	IIb 93/42	EUDAMED record Report an error
Foras	Türkiye	BiNefes SE-0193/42 BiNefes SH1093/42 BiNefes SH2093/42 BiNefes SP-10093/42 BiNefes SV-10093/42 69 others BiNefes T1993/42 BiNefes T2393/42 DEM ASV with humidifier93/42 DEM Autocpap with humidifier93/42 DEM Bipap Auto with humidifier93/42 DEM Bipap S/T Avaps with humidifier93/42 DEM Bipap S/T with humidifier93/42 DEM Bipap with humidifier93/42 DEM Cpap with humidifier93/42 DEM Elite with humidifier93/42 DEM SE-0193/42 DEM SH1093/42 DEM SH2093/42 DEM SV-10093/42 DEM T1993/42 DEM T2393/42 DEM Water Reservoir93/42 Foras SE-0193/42 Foras SH1093/42 Foras SH2093/42 Foras SV-10093/42 Foras T1993/42 Foras T2393/42 Nenni ASV with humidifier93/42 Nenni Autocpap with humidifier93/42 Nenni Bipap Auto with humidifier93/42 Nenni Bipap S/T Avaps with humidifier93/42 Nenni Bipap S/T with humidifier93/42 Nenni Bipap with humidifier93/42 Nenni Cpap with humidifier93/42 Nenni Elite with humidifier93/42 Nenni Water Reservoir93/42 SAHRA SE-0193/42 SAHRA SH1093/42 SAHRA SH2093/42 SAHRA SV-10093/42 SAHRA T1993/42 SAHRA T2393/42 Sleepas ASV with humidifier93/42 Sleepas Autocpap with humidifier93/42 Sleepas Bipap Auto with humidifier93/42 Sleepas Bipap S/T Avaps with humidifier93/42 Sleepas Bipap S/T with humidifier93/42 Sleepas Bipap with humidifier93/42 Sleepas Cpap with humidifier93/42 Sleepas Elite with humidifier93/42 Sleepas Water Reservoir93/42 TRVENT SE-0193/42 TRVENT SH1093/42 TRVENT SH2093/42 TRVENT SV-10093/42 TRVENT T1993/42 TRVENT T2393/42 Ventilas SE-0193/42 Ventilas SH1093/42 Ventilas SH2093/42 Ventilas SP-10093/42 Ventilas SV-10093/42 Ventilas T1993/42 Ventilas T2393/42 YEL ASV with humidifier93/42 YEL Autocpap with humidifier93/42 YEL Bipap Auto with humidifier93/42 YEL Bipap S/T Avaps with humidifier93/42 YEL Bipap S/T with humidifier93/42 YEL Bipap with humidifier93/42 YEL Cpap with humidifier93/42 YEL Elite with humidifier93/42 YEL Water Reservoir93/42	IIa, IIb 93/42	Website info@foras.com.tr EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	A8/A8C /A8 Pro/A80 /A80C/ A9/A9C /A9 Pro/A90 /A90C93/42 Anesthesia Machine A193/42 Anesthesia Machine A393/42 Anesthesia Machine A8 Pro93/42 Anesthesia Machine A8093/42 69 others Anesthesia Machine A80C93/42 Anesthesia Machine A8C93/42 Anesthesia Machine A9 Pro93/42 Anesthesia Machine A9093/42 Anesthesia Machine A90C93/42 Anesthesia Machine A9C93/42 Anesthesia Machine WATO EX-2093/42 Anesthesia Machine WATO EX-2593/42 Anesthesia Machine WATO EX-3093/42 Anesthesia Machine WATO EX-3593/42 Anesthesia System A593/42 Anesthesia System A793/42 Anesthesia System A893/42 Anesthesia System WATO EX-5593/42 Anesthesia System WATO EX-55 Pro93/42 Anesthesia System WATO EX-55C93/42 Anesthesia System WATO EX-55C Pro93/42 Anesthesia System WATO EX-65C93/42 Anesthesia System WATO EX-65C Pro93/42 Anesthesia System WATO EX-7593/42 Anesthesia System WATO EX-75C93/42 Anesthesia System WATO EX-8593/42 Anesthesia System WATO EX-85C93/42 Anesthetic Vaporizer V6093/42 Anesthetic Vaporizer V8093/42 Automated External Defibrillator BeneHeart C1A93/42 Automated External Defibrillator BeneHeart C293/42 Automated External Defibrillator BeneHeart D193/42 BeneVision N1 Central Monitoring System 60-14100-00/GA3202/GA3212/GA3211/040-001187-00/GA3201/60-14200-002 refs CO Module kit(B03B V2.0) BeneVision N173 refs Defibrillator/Monitor uMED 20/uMED 20A2 refs93/42 eGateway Integration Manager enteral feeding pump BeneFusion cNP/BeneFusion cDNP2 refs ePM 1293/42 Infusion Pump BeneFusion eVP/BeneFusion nVP ex/BeneFusion eVP ex/BeneFusion nVP Neo/BeneFusion eVP Neo/BeneFusion nVP3 refs Infusion Pump BeneFusion uVP/BeneFusion iVP/BeneFusion iVP ex/BeneFusion uVP ex3 refs Infusion Supervision System BeneFusion eDS ex/BeneFusion eDS/BeneFusion nDS ex/BeneFusion nDS3 refs Infusion Supervision System BeneFusion nCS MRI Infusion Workstation BeneFusion MRI Station NIBP Cuff CM11033 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 M19C3 refs Patient monitor BeneVision VMAX3 refs Patient Monitor cPM 15M3 refs Patient Monitor uMEC 302 refs Patient Monitor uMEC6, uMEC15S, uMEC15, uMEC10, uMEC7, uMEC126 refs93/42 Pulse Oximeter PM-6093/42 Syringe Pump BeneFusion eSP Neo/BeneFusion nSP/BeneFusion eSP ex/BeneFusion eSP/BeneFusion nSP ex/BeneFusion nSP Neo3 refs Syringe Pump BeneFusion uSP/BeneFusion iSP/BeneFusion uDSP ex/BeneFusion uSP ex/BeneFusion iSP ex/BeneFusion uDSP3 refs Telemetry Monitor TM80 V6093/42 Ventilator NB30093/42 Ventilator NB35093/42 Ventilator NB38093/42 Ventilator SV30093/42 Ventilator SV300 Pro93/42 Ventilator SV35093/42 Ventilator SV350 Pro93/42 Ventilator SV60093/42 Ventilator SV65093/42 Ventilator SV80093/42 Ventilator SV85093/42 Ventilator SynoVent E393/42 Ventilator SynoVent E593/42 Vital Signs Monitor VS-600 VS 9C WATO EX-6593/42 Wearable Patient Monitor EP30	I, IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Draeger FDA EU representative : Drägerwerk AG & Co. KGaA (Germany)	China, Germany, United States	Adapter NBP 1080036K19K0102 refs Atlan A100 301035FK19X0302 refs Atlan A300 301035FK19Z0002 refs Atlan A350 301035FK19T0102 refs Babylog VN600 304023FK19Z0002 refs 84 others CO2-Sensor Savina 300 36555693/42 D-Vapor 22519593/42 D-Vapor 3000 30137093/42 Dosiermodul D 22983493/42 Dosiermodul I 22979793/42 Dosiermodul S 22981093/42 Evita V600 304022FK19Z0002 refs EXC Dosiermodul D 56515493/42 Fabius MRI 04149893/42 HEMOMED POD 00854993/42 IACS Monitoring with C700 307028XK13Z010 IBP Adapter Cable Drager 10pin 1080566K19Z0003 refs Infinity Acute Care System C500 2307028XK13Z00 Infinity Central Station Wide 307006XK19Z000 INFINITY M300 BEDSIDE CHARGER 307005VK13K0103 refs INFINITY MASIMO SP02 POD USB 05073993/42 INFINITY MASIMO SPO2 POD X8 05074693/42 INFINITY MCABLE DUAL HEMO 307028VK19K0102 refs INFINITY MPOD-QUAD HEMO 307035VK16K010 Infinity Nellcor SpO2 Pod X8 04930693/42 INFINITY® M540 307028XK13Z0203 refs M540 HEMO-VERBIND.KABEL 1.5M 1307035XK12Z012 refs MCable-Mainstream CO2 05368693/42 NBP Anschlussschlauch, Erw 3,7m 1080036K19Z0003 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 OR-PC 24 for Vista CMS 38300093/42 Oxylog 3000 plus 304015FK19Z0002 refs Perseus A500 301031FK19Z000 POD MULTIMED 12-Lead + SpO2 00852593/42 PulmoVista 500 1204026VK19Z00 PulmoVista 500 25260393/42 Savina 300 41162893/42 Savina 300, System 25142293/42 Seattle PAP 308041XK19Z0002 refs SHP UNT INFINITY CNAP POD 05068593/42 SPO2 DRÄGER ERN. SCHAUM, 24STK 00535793/42 SPO2 DRÄGER ERW. VINYL, 24STK 00531993/42 SPO2 DRÄGER NERO BAND, 24 STK 00534093/42 SPO2 DRÄGER PÄD. SCHAUM, 24STK 00536493/42 SPO2 DRÄGER PÄD. VINYL, 24STK 00532693/42 SPO2 DRÄGER SÄUGL. BAND, 24STK 00533393/42 SPO2-Sensor, Dräger, Mehrweg 00701693/42 Vapor 2000 22805993/42 Vapor 3000 30136393/42 Vista 120 C.O. Model C 54808993/42 Vista 120 Nellcor Model A 54809693/42 Vista 120 Nellcor Model C 55750093/42 Vista 120 Non-Inv Model A 54807293/42 Vista 120 SC Model A Br 307003VK19Z0003 refs Vista 120/S Monitor 56615193/42 Vista 120S C.O. model C 43889293/42 Vista 120S C.O. Nellcor model C+ 44101493/42 Vista 120S neinvazivní, model A 43888593/42 Vista 120S Nellcor Model A 44100793/42 Vista 300 Invasive Model C3 refs Vista Telemetry T100 Model A 4307009VK19Z003 refs Zeus IE 24893493/42 CNAP CUFF CONTROLLER CABLE 00572293/42 (no longer marketed) CNAP SENSOR CUFF, SMALL 00571593/42 (no longer marketed) CNAP SENSORMANSCHETTE, L 00569293/42 (no longer marketed) CNAP SENSORMANSCHETTE, M 00570893/42 (no longer marketed) CO2 Hauptstromsensor 204024VK19Z000 (no longer marketed) Delta Monitor 00415293/42 (no longer marketed) DeltaXL Monitor 00416993/42 (no longer marketed) Evita V300 38935493/42 (no longer marketed) Fabius GS premium 04146793/42 (no longer marketed) Fabius Plus 04148193/42 (no longer marketed) Fabius Plus XL 37761093/42 (no longer marketed) Fabius Tiro 04147493/42 (no longer marketed) Fabius Tiro D-M 25100293/42 (no longer marketed) Infinity Explorer Monitor 00406093/42 (no longer marketed) Infinity Kappa Monitor 00403993/42 (no longer marketed) Infinity Omega Monitor 00273893/42 (no longer marketed) Oxylog VE300 304019FK19Z000 (no longer marketed) Primus 04143693/42 (no longer marketed) Primus IE 22474793/42 (no longer marketed) Savina System 01640393/42 (no longer marketed) Workstation Critical Care 04226693/42 (no longer marketed) Workstation NC 25041893/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	Website EUDAMED@draeger.com EUDAMED record Report an error
Beijing Choice Electronic Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	FL31393/42 FL32393/42 Handheld Pulse Oximeter MD300M93/42 LTD80093/42 LTD80593/42 60 others M-50B93/42 M-50C93/42 M-50E93/42 MD2000A93/42 MD2000B93/42 MD2000C93/42 MD300K293/42 MD300M93/42 MD300W62893/42 ME593/42 PM A1093/42 PM A1993/42 PO 4593/42 Pulse Oximeter MD300C1393/42 Pulse Oximeter MD300C1993/42 Pulse Oximeter MD300C293/42 Pulse Oximeter MD300C20393/42 Pulse Oximeter MD300C20893/42 Pulse Oximeter MD300C2193/42 Pulse Oximeter MD300C2293/42 Pulse Oximeter MD300C22893/42 Pulse Oximeter MD300C2393/42 Pulse Oximeter MD300C2693/42 Pulse Oximeter MD300C2993/42 Pulse Oximeter MD300C4193/42 Pulse Oximeter MD300C593/42 Pulse Oximeter MD300C5293/42 Pulse Oximeter MD300C5393/42 Pulse Oximeter MD300C5493/42 Pulse Oximeter MD300C5593/42 Pulse Oximeter MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, OX2003 refs Pulse Oximeter MD300CI21693/42 Pulse Oximeter MD300CI216R, MD300CI218R2 refs Pulse Oximeter MD300CI21893/42 Pulse Oximeter MD300CN13093/42 Pulse Oximeter MD300CN14093/42 Pulse Oximeter MD300CN15093/42 Pulse Oximeter MD300CN16093/42 Pulse Oximeter MD300CN31093/42 Pulse Oximeter MD300CN33093/42 Pulse Oximeter MD300CN330R, MD300CN350R, MD300CN356R3 refs Pulse Oximeter MD300CN34093/42 Pulse Oximeter MD300CN35093/42 Pulse Oximeter MD300CN35693/42 Pulse Oximeter MD300CN36093/42 Pulse Oximeter MD300K293/42 Pulse Oximeter MD300K2N Pulse Oximeter MD300MNR Pulse Oximeter MD300W series2 refs Pulse Oximeter OX20093/42 Pulse Oximeter OXY30093/42 Pulse Oximeter P300 Intelli IT(HPO-300T)93/42 PX-100-EU93/42 PX-101-EEU93/42 PX-101-EU93/42 TS 370PO93/42 TS 380PO93/42 Vital Sign Monitor MD2000A13 refs Vital Sign Monitor MD2000C93/42 Wrist Pulse Oximeter MD300W62893/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Fudakang FDA EU representative : MedPath GmbH (Germany)	China	Electronic Blood Pressure Monitor Arm Type FT-C0193/42 Electronic Blood Pressure Monitor Arm Type FT-C01-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0293/42 Electronic Blood Pressure Monitor Arm Type FT-C02-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C02B93/42 55 others Electronic Blood Pressure Monitor Arm Type FT-C02B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0393/42 Electronic Blood Pressure Monitor Arm Type FT-C03-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0493/42 Electronic Blood Pressure Monitor Arm Type FT-C04-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C04B93/42 Electronic Blood Pressure Monitor Arm Type FT-C04B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C04Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C04Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0593/42 Electronic Blood Pressure Monitor Arm Type FT-C05-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C05Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C05Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0693/42 Electronic Blood Pressure Monitor Arm Type FT-C06-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C06B93/42 Electronic Blood Pressure Monitor Arm Type FT-C06B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0793/42 Electronic Blood Pressure Monitor Arm Type FT-C07-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0893/42 Electronic Blood Pressure Monitor Arm Type FT-C08-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C08B93/42 Electronic Blood Pressure Monitor Arm Type FT-C08B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C0993/42 Electronic Blood Pressure Monitor Arm Type FT-C09-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C09B93/42 Electronic Blood Pressure Monitor Arm Type FT-C09B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C1193/42 Electronic Blood Pressure Monitor Arm Type FT-C11-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C11B93/42 Electronic Blood Pressure Monitor Arm Type FT-C11B-BT93/42 Electronic Blood Pressure Monitor Arm Type FT-C11B-UR93/42 Electronic Blood Pressure Monitor Arm Type FT-C11B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C12B93/42 Electronic Blood Pressure Monitor Arm Type FT-C12B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C13B93/42 Electronic Blood Pressure Monitor Arm Type FT-C13B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C14B93/42 Electronic Blood Pressure Monitor Arm Type FT-C14B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C15B93/42 Electronic Blood Pressure Monitor Arm Type FT-C15B-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C15Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C15Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C21Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C21Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C22Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C22Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C23Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C23Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C24Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C24Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C25Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C25Y-V93/42 Electronic Blood Pressure Monitor Arm Type FT-C26Y93/42 Electronic Blood Pressure Monitor Arm Type FT-C26Y-V93/42	IIa 93/42	Website EUDAMED record Report an error
Masimo FDA EU representative : MDSS GmbH (Germany)	United States	EMMA Capnograph kPa3 refs Intellivue Module2 refs93/42 iSpO2 Rx , USB-C, Pediatric93/42 iSpO2 Rx, USB-C, Adult93/42 iSpO2 Rx, USB-C, RD93/42 53 others Masimo SafetyNet Masimo SafetyNet, Radius PPG Chip3 refs Masimo SET SpO Cable, E30 uSpO293/42 Masimo SET SpO Cable, USB uSpO293/42 Masimo SET Module, LNC2 refs Masimo W1 MightySat93/42 MightySat Rx6 refs O3 Regional Oximeter3 refs O3 Sensors2 refs Pronto3 refs93/42 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-576 refs93/42 Rad-57c93/42 Rad-57cm2 refs93/42 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-P93/42 Rad-5v Handheld, Pediatric93/42 Rad-67, Pulse CO-Oximeter (Spot-check) Rad-972 refs Rad-97 Home Use with noninvasive blood pressure2 refs Rad-97 with NomoLine Capnography Rad-G5 refs Radical-72 refs Radius PPG Kit, M202 refs Radius PPG Wireless Receiver93/42 Radius VSM - ECG Electrode Adult 3-Lead3 refs Radius VSM Disposable NIBP Cuff3 refs Radius VSM Monitor Radius VSM with Reusable Pod & NIBP Radius-72 refs93/42 rainbow SET COOximetry Module rainbow SET Module Carescape2 refs93/42 rainbow SET IntelliVue Module2 refs93/42 Rainbow Set Module93/42 Rainbow Set Module for Welch Allyn93/42 rainbow SET Pulse CO-Oximetry Cable, Carescape Sp02, Masimo, 0.9m Cable93/42 rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo93/42 Root, Masimo93/42 Root, NIBP and Temperature uSpO2 Pulse Oximetry Cable for GE ApexPro CH, CARESCAPE Telemetry T4 & T143 refs uSpO2 Masimo SET Oximetry Cable6 refs93/42 uSpO2 Masimo SET Oximetry Cable, USB93/42	IIb MDR, 93/42	Website customerorders@masimo.com EUDAMED record Report an error
Contecmed FDA EU representative : Prolinx GmbH (Germany)	China	Ambulatory Blood Pressure Monitor ABDM-5093/42 Ambulatory Blood Pressure Monitor ABPM50 Capnograph CA10M Electronic Sphygmomanometer BP-10093/42 Electronic Sphygmomanometer CONTEC07A 45 others Electronic Sphygmomanometer CONTEC08A Electronic Sphygmomanometer CONTEC08A-BT93/42 Electronic Sphygmomanometer CONTEC08C Electronic Sphygmomanometer CONTEC08D93/42 Electronic Sphygmomanometer CONTEC08E93/42 Infusion Pump SP750 Patient Monitor CMS600093/42 Patient Monitor CMS700093/42 Patient Monitor CMS800093/42 Patient Monitor CMS900093/42 Pulse Oximeter ANP10093/42 Pulse Oximeter CMS50-Pro93/42 Pulse Oximeter CMS50D+93/42 Pulse Oximeter CMS50D-BT93/42 Pulse Oximeter CMS50D193/42 Pulse Oximeter CMS50D293/42 Pulse Oximeter CMS50D2-193/42 Pulse Oximeter CMS50DL, CMS50D2 refs Pulse Oximeter CMS50DL193/42 Pulse Oximeter CMS50DL293/42 Pulse Oximeter CMS50E93/42 Pulse Oximeter CMS50F93/42 Pulse Oximeter CMS50I93/42 Pulse Oximeter CMS50M93/42 Pulse Oximeter CMS50N93/42 Pulse Oximeter CMS50Q193/42 Pulse Oximeter CMS50QA93/42 Pulse Oximeter CMS50QB93/42 Pulse Oximeter CMS60C93/42 Pulse Oximeter CMS60D93/42 Pulse Oximeter CMS60D193/42 Pulse Oximeter CMS70A93/42 Pulse Oximeter NX-8740-67593/42 Pulse Oximeter PO-10093/42 Pulse Oximeter PO-20093/42 Pulse Oximeter PO-200A Solo93/42 Pulse Oximeter PO-200Solo93/42 Pulse Oximeter PO-23093/42 Pulse Oximeter PO-25093/42 Pulse Oximeter PO-30093/42 Pulse Oximeter PO-40093/42 Pulse Oximeter PO-650A93/42 Pulse Oximeter PO-650B93/42 Pulse Oximeter PO-90093/42 Pulse Oximeter SAT-50093/42	IIa, IIb MDR, 93/42	Website pms.qms@contecmed.com EUDAMED record Report an error
Zhejiang Haisheng Medical Device FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	/93/42 DBPT-01036 refs93/42 DBPT-04032 refs93/42 DBPT-0803C393/42 DBPT-090393/42 45 others DBPT-10032 refs93/42 Disposable Pressure Transducer3 refs Disposable Pressure Transducer DBPT-010393/42 Disposable Pressure Transducer DBPT-013093/42 Disposable Pressure Transducer DBPT-020393/42 Disposable Pressure Transducer DBPT-023093/42 Disposable Pressure Transducer DBPT-030393/42 Disposable Pressure Transducer DBPT-033093/42 Disposable Pressure Transducer DBPT-040393/42 Disposable Pressure Transducer DBPT-043093/42 Disposable Pressure Transducer DBPT-0503C1093/42 Disposable Pressure Transducer DBPT-0503C393/42 Disposable Pressure Transducer DBPT-0503C593/42 Disposable Pressure Transducer DBPT-0503C693/42 Disposable Pressure Transducer DBPT-0530C1093/42 Disposable Pressure Transducer DBPT-0530C393/42 Disposable Pressure Transducer DBPT-0530C593/42 Disposable Pressure Transducer DBPT-0530C693/42 Disposable Pressure Transducer DBPT-0603C1093/42 Disposable Pressure Transducer DBPT-0603C393/42 Disposable Pressure Transducer DBPT-0603C593/42 Disposable Pressure Transducer DBPT-0603C693/42 Disposable Pressure Transducer DBPT-0630C1093/42 Disposable Pressure Transducer DBPT-0630C393/42 Disposable Pressure Transducer DBPT-0630C593/42 Disposable Pressure Transducer DBPT-0630C693/42 Disposable Pressure Transducer DBPT-0703C1093/42 Disposable Pressure Transducer DBPT-0703C393/42 Disposable Pressure Transducer DBPT-0703C593/42 Disposable Pressure Transducer DBPT-0703C693/42 Disposable Pressure Transducer DBPT-0730C393/42 Disposable Pressure Transducer DBPT-0730C593/42 Disposable Pressure Transducer DBPT-0730C693/42 Disposable Pressure Transducer DBPT-0803C1093/42 Disposable Pressure Transducer DBPT-0803C393/42 Disposable Pressure Transducer DBPT-0803C593/42 Disposable Pressure Transducer DBPT-0803C693/42 Disposable Pressure Transducer DBPT-0830C1093/42 Disposable Pressure Transducer DBPT-0830C393/42 Disposable Pressure Transducer DBPT-0830C593/42 Disposable Pressure Transducer DBPT-0830C693/42 Disposable Pressure Transducer DBPT-090393/42 Disposable Pressure Transducer DBPT-093093/42 Disposable Pressure Transducer DBPT-100393/42 Disposable Pressure Transducer DBPT-103093/42	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, United States	3 LEADS SET DISPOSABLE, BEDSIDE IEC RD3 refs 989803192931 SureSigns VS4 NBP, SPO2_Accessories93/42 Adt Nsl CO2 Line LTerm3 refs Adt Nsl CO2 Line w/O2 STerm93/42 Adt Nsl CO2 Line w/O2 STerm Lng93/42 50 others Adt Orl/Nsl CO2 Line w/O2 Conn STerm93/42 Adt Orl/Nsl CO2 Line w/O2 Conn STerm Lng93/42 Adt Orl/Nsl CO2 Line w/O2 LTerm93/42 Adt Orl/Nsl CO2 Line w/O2 LTerm Lng93/42 Adt Orl/Nsl CO2 Line w/O2 STerm93/42 Adt/Med BiteBlk CO2 Line w/O2 Conn STerm93/42 Adt/Med BiteBlk CO2 Line w/O2 STerm93/42 Adt/Med BiteBlk CO2 Line w/O2 STerm Lng93/42 ADULT FOAM ECG ELECTRODE, DISPOSABLE3 refs ADULT NIBP AIR HOSE 3.0M2 refs Avalon CL Fetal & Maternal Patch Care Assist Android2 refs CBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE Reusable Leadsets/ECG leads/SPO2 Cables3 refs CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE IntelliVue MX40 Single-Patient-Use Cable93/42 CBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele IntelliVue MX40 Single-Patient-Use Cable93/42 COMFORT CARE CUFF, ADULT3 refs EFFICIA 3-LEAD GRABBER, AAMI3 refs G-Series patient monitor, Model is G30E2 refs Heartstart FRx93/42 HeartStart HS1 Defibrillator and Accs.93/42 INFANT SINGLE-PATIENT CUFF SIZE #53 refs IntelliVue Active Display AD75 AD75/AD85 Active Displays2 refs IntelliVue MP593/42 IntelliVue Patient Monitor MP5SC93/42 IntelliVue Patient Monitor MX400 MX400-5503 refs IntelliVue Patient Monitor MX700 MX700/80093/42 IntelliVue Patient Monitor MX750 MX750/8502 refs IntelliVue Patient Monitor MX800 MX700/80093/42 IntelliVue XDS Software Invasive Blood Pressure Module93/42 Nasal Alar SpO2 Sensor FAST Only, 20/CS Alar Nasal SpO2 Sensors93/42 Nasal Alar SpO2 Sensor MLT CPTL, 24/CS Alar Nasal SpO2 Sensors93/42 Neo/Inf Nsl CO2 Line w/O2 LTerm93/42 NEONATAL NIBP AIR HOSE 1.5M2 refs NEONATAL/PEDIATRIC SNAP ELECTRODE,SQUARE3 refs Patient Information Center iX Patient Monitor 6100 Patient Monitor 6000 Series3 refs Pedi Nsl CO2 Line w/O2 LTerm93/42 Pedi Nsl CO2 Line w/O2 STerm93/42 Pedi Orl/Nsl CO2 Line w/O2 LTerm93/42 Pedi Orl/Nsl CO2 Line w/O2 LTerm Lng93/42 Pedi Orl/Nsl CO2 Line w/O2 STerm93/42 Pedi Orl/Nsl CO2 Line w/O2 STerm Lng93/42 Telemetry Monitor 5500 Adt Nsl CO2 Line w/O2 LTerm93/42 (no longer marketed) Adt Orl/Nsl CO2 Line w/O2 STerm Lng93/42 (no longer marketed) E/R Temp Probe 10 FR Reuse Autoclavable93/42 (no longer marketed) E/R Temp Probe 12 FR Reuse Autoclavable93/42 (no longer marketed) Esophageal/Rectal Temperature Probe93/42 (no longer marketed) Skin Temp Probe Reusable Autoclavable93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	eudamed@philips.com EUDAMED record Report an error
Rossmax FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Switzerland, Taiwan	Cuff BP_CF_005_003 refs RESQ-METER SB20093/42 Rossmax SA30093/42 Rossmax SA31093/42 Rossmax SB10093/42 38 others Rossmax SB20093/42 Rossmax SB21093/42 Rossmax SB22093/42 Rossmax SD10093/42 Upper arm blood pressure monitor AU941f93/42 Upper arm blood pressure monitor AV151f93/42 Upper arm blood pressure monitor AW150f93/42 Upper arm blood pressure monitor AW175f93/42 Upper arm blood pressure monitor AX356f93/42 Upper arm blood pressure monitor C593/42 Upper arm blood pressure monitor CF155f93/42 Upper arm blood pressure monitor CF175f93/42 Upper arm blood pressure monitor CF707f93/42 Upper arm blood pressure monitor CG155f93/42 Upper arm blood pressure monitor CG175f93/42 Upper arm blood pressure monitor CH155f93/42 Upper arm blood pressure monitor MA350f93/42 Upper arm blood pressure monitor MA801f93/42 Upper arm blood pressure monitor MG150f93/42 Upper arm blood pressure monitor MH901f93/42 Upper arm blood pressure monitor MJ701f93/42 Upper arm blood pressure monitor MW701f93/42 Upper arm blood pressure monitor Q393/42 Upper arm blood pressure monitor with PARR function (professional) AC1000f93/42 Upper arm blood pressure monitor with PARR function (professional) X993/42 Upper arm blood pressure monitor with PARR function C593/42 Upper arm blood pressure monitor with PARR function Q593/42 Upper arm blood pressure monitor with PARR function X593/42 Upper arm blood pressure monitor with PARR function Z593/42 Upper arm blood pressure monitor X193/42 Upper arm blood pressure monitor X393/42 Upper arm blood pressure monitor Z193/42 Wrist blood pressure monitor BC35193/42 Wrist blood pressure monitor BI70193/42 Wrist blood pressure monitor BQ70593/42 Wrist blood pressure monitor BR70593/42 Wrist blood pressure monitor K15093/42 Wrist blood pressure monitor S15093/42	I, IIa, IIb MDR, 93/42	Website info@rossmax.com EUDAMED record Report an error
Ajmedical	Sweden	3in 1 cuff hölje Blood pressure cuff AJM-1305-01 Blood pressure cuff AJM-1306-01 Blood pressure cuff AJM-1313 Blood pressure cuff AJM-1314 37 others Blood pressure cuff AJM-1315 Blood pressure cuff AJM-1316 Blood pressure cuff AJM-1317 Blood pressure cuff AJM-1318 Blood pressure cuff AJM-1319 Blood pressure cuff AJM-1320 Blood pressure cuff AJM-8013 Blood pressure cuff AJM-8014 Blood pressure cuff AJM-8015 Blood pressure cuff AJM-8018 Blood pressure cuff AJM-8019 Blood pressure cuff AJM-8020 Blood pressure cuff AJM-8030 Blood pressure cuff AJM-8032 Blood pressure cuff AJM-8034 Blood pressure cuff AJM-8035 Blood pressure cuff AJM-8036 Blood pressure cuff AJM-8037 Blood pressure cuff AJM-8038 Manual blood pressure monitor AJM-8001-00E Manual blood pressure monitor AJM-8001-00ET Manual blood pressure monitor AJM-8002-00E Manual blood pressure monitor AJM-8002-00ET Manual blood pressure monitor AJM-8003-00E Manual blood pressure monitor AJM-8003-00ET Manual blood pressure monitor AJM-8004-00E Manual blood pressure monitor AJM-8004-00ET Manual blood pressure monitor AJM-8005-00E Manual blood pressure monitor AJM-8005-00ET Manual blood pressure monitor AJM-8006-00E Manual blood pressure monitor AJM-8006-00ET Manual blood pressure monitor AJM-8020-00E Manual blood pressure monitor AJM-8020-00ET Manual blood pressure monitor AJM-8021-00E Manual blood pressure monitor AJM-8021-00ET Pumpboll Pumpboll (liten)	I MDR	Website info@ajmedical.se EUDAMED record Report an error
Medcaptain FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Anesthesia System Supaera 50A, Supaera 50, Supaera 50 Plus, Supaera 50 Pro, Supaera 50P DS70093/42 ELFensor P2、ELFensor P5、ELFensor P8、ELFensor P3、ELFensor P6、ELFensor P93 refs EP-6093/42 EP-60C93/42 33 others EP-90, EP-90T, EP-90 Ex, EP-90 PRO3 refs HP TCI93/42 HP TCI PRO93/42 HP-30, HP-30 Neo, HP-30 PRO, S700, S720 PCA HP-60, HP-60C, HP-60 PRO, HP-60C PRO, V700 HP-8093/42 HP-80 MRI93/42 HP-80 PRO93/42 iCMS,BD neXus Medication Safeware MP-3093/42 MP-30A93/42 MP-30T93/42 MP-6093/42 MP-60A93/42 MP-60C93/42 MP-60T93/42 MP-8093/42 MP-80A93/42 MP-80T93/42 MRI 70093/42 MS-10093/42 S740 TCI93/42 SYS-5093/42 SYS-5293/42 SYS-5693/42 SYS-5893/42 SYS-601093/42 SYS-6010A93/42 SYS-6010T93/42 SYS-7093/42 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	IIa, IIb MDR, 93/42	Website info@medcaptain.com EUDAMED record Report an error
Modül Grup Mühendislik Elektr Med İnş Eğt Ve Bilş San Tic Şti	Türkiye	Medrag Babylite93/42 Medrag Babysmart93/42 Medrag Easy93/42 Medrag Life93/42 Medrag Mdr193/42 33 others Medrag Mdr293/42 Medrag Mdr2 Plus93/42 Medrag Mdr393/42 Medrag Mdr493/42 Medrag Mdr4 Plus93/42 Medrag Mdr593/42 Medrag Mdr5 Plus93/42 Medrag Medhome93/42 Meventi Babylite93/42 Meventi Babysmart93/42 Meventi Basic93/42 Meventi Life93/42 Meventi Mevhome93/42 Meventi Mt193/42 Meventi Mt293/42 Meventi Mt2 Plus93/42 Meventi Mt393/42 Meventi Mt493/42 Meventi Mt4 Plus93/42 Meventi Mt593/42 Meventi Mt5 Plus93/42 Oxi2 Plus93/42 Oxivent Babylite93/42 Oxivent Easy93/42 Oxivent Life93/42 Oxivent Oxi193/42 Oxivent Oxi293/42 Oxivent Oxi393/42 Oxivent Oxi493/42 Oxivent Oxi4 Plus93/42 Oxivent Oxi593/42 Oxivent Oxi5 Plus93/42 Oxivent Oxihome93/42	IIb 93/42	Website EUDAMED record Report an error
Resvent FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	BPAP System iBreeze 25A93/42 BPAP System iBreeze 25A Pro93/42 BPAP System iBreeze 25S93/42 BPAP System iBreeze 25ST93/42 BPAP System iBreeze 25STA93/42 32 others BPAP System iBreeze 25STA Pro93/42 BPAP System iBreeze 30ST93/42 BPAP System iBreeze 30STA93/42 BPAP System iBreeze 30STA Pro93/42 BPAP System iBreeze Tech93/42 BPAP System RXiBreeze 25A plus93/42 BPAP System RXiBreeze 25A Pro93/42 BPAP System RXiBreeze 25S plus Pro93/42 BPAP System RXiBreeze 25ST plus93/42 BPAP System RXiBreeze 25STA93/42 BPAP System RXiBreeze 25STA plus93/42 CPAP System iBreeze 20A93/42 CPAP System iBreeze 20A Pro93/42 CPAP System iBreeze 20C93/42 CPAP System iBreeze 20C Pro93/42 CPAP System iBreeze F20A93/42 CPAP System iBreeze F20A Pro93/42 CPAP System iBreeze F20C Pro93/42 CPAP System RXiBreeze 20A Pro93/42 CPAP System RXiBreeze 20C Pro93/42 CPAP System RXiBreeze 20C Plus93/42 CPAP System RXiBreeze20A Plus93/42 Positive Airway Pressure System (PAP System) iBreeze 20C, iBreeze 20A3 refs Positive Airway Pressure System (PAP System) iBreeze 25STA, iBreeze 30STA3 refs Positive Airway Pressure System (PAP System) RXiBreeze 20A Plus, RXiBreeze 20C Plus2 refs Positive Airway Pressure System(PAP System) RXiBreeze Ⅲ CPAP, RXiBreeze Ⅲ CPAP Pro, RXiBreeze Ⅲ APAP, RXiBreeze Ⅲ APAP Pro3 refs RS10093/42 RS20093/42 RS30093/42 RV10093/42 RV20093/42 Ventilator RS3003 refs	IIa, IIb MDR, 93/42	Website info@resvent.com EUDAMED record Report an error
ResMed FDA EU representative : ResMed SAS (France)	Australia	AIRCURVE 10 CS PACEWAVE CZECH TRI3 refs AIRCURVE 10 CS-A PACEWAVE EUR3 refs AIRCURVE 10 VAUTO CZECH TRI AirCurve 10 S, AirCurve 10 ST, AirCurve 10 VAuto3 refs AIRCURVE 11 ASV PACEWAVE CH3 refs AIRCURVE 11 S DE AirCurve 11 S , AirCurve 11 ST , AirCurve 11 VAuto3 refs 29 others AIRCURVE 11 VPAP TX EU TRI AIRSENSE 10 AUTOSET CH C2C AirSense 10 AutoSet , AirSense 10 Elite , AirSense 10 AutoSet For Her , AirSense 10 AutoSet No CAM (C2C)3 refs AIRSENSE 11 AUTOSET EU TRI AirSense 11 AutoSet , AirSense 11 Elite3 refs Astral 100 - DEU Astral 100/15093/42 Astral 100 - EUR1 Astral 100/15093/42 Astral 100 - EUR2 Astral 100/15093/42 Astral 100 - EUR3 Astral 100/15093/42 Astral 100 - EUR4 Astral 100/15093/42 Astral 100 - FRA Astral 100/15093/42 Astral 100 SC - DEU Astral 100/15093/42 Astral 150 - DEU Astral 100/15093/42 Astral 150 - EUR1 Astral 100/15093/42 Astral 150 - EUR2 Astral 100/15093/42 Astral 150 - EUR3 Astral 100/15093/42 Astral 150 - FRA Astral 100/15093/42 Astral 150 -EUR4 Astral 100/15093/42 LUMIS 100 VPAP ST EUR3 UB Lumis 100 VPAP S , Lumis 100 VPAP ST , Lumis 150 VPAP ST3 refs LUMIS 100 VPAP ST-A EUR2 Lumis 150 VPAP ST-A , Lumis 100 VPAP ST-A3 refs Lumis 11 ST-A DE3 refs Lumis 150 VPAP ST EUR1 Lumis 100 VPAP S,Lumis 100 VPAP ST,Lumis 150 VPAP ST93/42 Stellar 100 - Eur G1 Stellar 100/130/15093/42 Stellar 100 - France Stellar 100/130/15093/42 Stellar 100 - UK Stellar 100/130/15093/42 STELLAR 130 GERMANY Stellar 100/130/15093/42 Stellar 150 Europe Grp1 Stellar 100/130/15093/42 Stellar 150 Europe Grp2 Stellar 100/130/15093/42 Stellar 150 France Stellar 100/130/15093/42 Stellar 150 Germany (GmbH) Stellar 100/130/15093/42 Stellar 150 UK Stellar 100/130/15093/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Beurer	Germany	BC 2193/42 BC 283 refs93/42 BC 30/193/42 BC 4493/42 BC 51 27 others BC 542 refs BC 87 BM 253 refs BM 25/1 BM 2693/42 BM 273 refs BM 283 refs BM 35/193/42 BM 402 refs93/42 BM 45 BM 48/12 refs BM 494 refs93/42 BM 5193/42 BM 532 refs BM 54 BM 5893/42 BM 59 BM 64 BM 8193/42 BM 8593/42 BM 9693/42 BMCU 3544 PO 13 PO 302 refs PO 35 PO 4593/42 PO 60	I, IIa MDR, 93/42	info@beurer.de EUDAMED record Report an error
Bioptimal International PTE FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	Singapore	Accutrans AT 4812-393/42 Accutrans AT 4812-3(CROATIA)93/42 Accutrans AT 4812-3R93/42 Accutrans AT 6012-3 (AT 6012-3B)93/42 Accutrans AT 6012-3 (AT 6012-3R)93/42 27 others Accutrans AT BC-248A (EUROPE-CAT# AT 248-A MV)93/42 Accutrans AT2 4812-393/42 Accutrans AT2 4812-3(CROATIA)93/42 Accutrans AT2 4812-3RB (IM2 4812-3RB)93/42 Accutrans AT3 4812-3 (IM3 4812-3)93/42 Accutrans AT3 4812-3(CROATIA)93/42 Bioptimal Accutrans AT 4812-3 (IM 4812-3)93/42 Bioptimal Accutrans AT2 4812-3 (IM2 4812-3)93/42 Bioptimal Biotrans IN-LINE SENSOR (SP5045)93/42 Bioptimal Biotrans Reusable Sensor Base BT-2013 refs93/42 Bioptimal Biotrans Reusable Sensor Base BTR-393/42 Bioptimal Pressure Monitoring Systems and Kits - Accutrans AT 24-3093/42 Bioptimal Pressure Monitoring Systems and Kits - Accutrans AT 4812-393/42 Bioptimal Pressure Monitoring Systems and Kits - Accutrans AT-3093/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR2 refs93/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR-2448-3-BP293/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR-32 refs93/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR-3093/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR-4812-393/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR-603693/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR2-2448-3-BP22 refs93/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR2-4812-393/42 Bioptimal Pressure Monitoring Systems and Kits - Biotrans BTR4812-393/42 Bioptimal Pressure Monitoring Systems and Kits - Catrans CT2 refs93/42 Bioptimal Pressure Monitoring Systems and Kits - Catrans CT (TC)2 refs93/42 Biotrans HPT20 (Sonimed)93/42 Biotrans HPT30(Croatia)93/42	IIa 93/42	Website ra-bpi@bioptimalg.com EUDAMED record Report an error
Codan FDA	Germany	Adapter, 1-fold Zubehör / Accessory IBPM3 refs Arterial blood sampling system ABSS3 refs Arterial extension line5 refs Blood sampling stopcock3 refs Cable-Extension, 1-fold - Special Zubehör / Accessory IBPM3 refs 27 others Contactboard, 1-fold - FX Zubehör / Accessory IBPM3 refs Dampening stopcock2 refs Filling system3 refs Holder single, adjustable Zubehör / Accessory IBPM3 refs Modular mounting system Zubehör / Accessory IBPM3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , ABSS3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , CLC3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , NBSS3 refs Monitoring set with CVP limb Xtrans® / DPT-6000 , SWAN Switch3 refs Monitoring set, addition green line® - Xtrans®/DPT-60003 refs Monitoring set, addition green line® - Xtrans®/DPT-6000 , CLC3 refs Monitoring set, double green line® - Xtrans® / DPT-6000 , NBSS3 refs Monitoring set, single green line® - Xtrans®/DPT-6000 , NBSS3 refs Monitoring set, single green line® - Xtrans®/DPT-6000 , SWAN Switch Monitoring set, single Xtrans® / DPT-6000 , NBSS3 refs Monitoring set, single Xtrans® / DPT-6000 , SWAN Switch3 refs Monitoring set, single Xtrans® / DPT-6000, ABSS3 refs Monitoring set, single Xtrans®/DPT-60003 refs Monitoring set, single Xtrans®/DPT-6000 , CLC3 refs Mounting plate, quadruple Zubehör / Accessory IBPM Mounting plate, Single Zubehör / Accessory IBPM3 refs Needle-free blood sampling system3 refs Pressure transducer green line® - Xtrans®/DPT-60009 refs Sampling adapter HG-012 refs Satellite, 1-fold - Plug Zubehör / Accessory IBPM3 refs Stopcock, 4-way, blue SWAN Switch3 refs Velcro Strip Zubehör / Accessory IBPM3 refs	I, IIa, IIb MDR	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-JC3123 refs BP-JC31293/42 BP310A93/42 BP311A93/42 BP313A93/42 25 others BP317A93/42 BP320A93/42 BP351A93/42 BP353A93/42 BP358A93/42 BP359A93/42 BP362A93/42 BP366A93/42 BP369A93/42 BP380A93/42 BP385A93/42 BP387A93/42 BP389A93/42 BP390A93/42 BP391A93/42 Wrist type automatic blood pressure monitor BP-JC16093/42 Wrist type automatic blood pressure monitor BP163W93/42 Wrist type automatic blood pressure monitor BP166W93/42 Wrist Type Automatic Blood Pressure Monitor BP168W93/42 Wrist Type Automatic Blood Pressure Monitor BP168W, BP166W, BP169W, BP163W, BP165W, BP188W,BP189W, BP-JC160, BP180W, BP182W, BP183W,BP185W, BP186W, BP187W3 refs Wrist type automatic blood pressure monitor BP169W93/42 Wrist type automatic blood pressure monitor BP182W93/42 Wrist type automatic blood pressure monitor BP183W2 refs93/42 Wrist type automatic blood pressure monitor BP185W93/42 Wrist type automatic blood pressure monitor BP188W93/42	IIa MDR, 93/42	Website info@szjiakang.com EUDAMED record Report an error
Bosch Sohn U	Germany	boso BS90 BS 9093/42 boso classic93/42 boso classic merkur 2S93/42 boso classic privat93/42 boso classic saturn GS93/42 23 others boso classic venus SG93/42 boso classico93/42 boso clinicus I5 refs93/42 boso clinicus II5 refs93/42 boso clinicus S93/42 boso egotest2 refs93/42 boso fix2 refs93/42 boso KI93/42 boso KII93/42 boso manuell2 refs93/42 boso med I2 refs93/42 boso minimus Clip93/42 boso minimus Ring93/42 boso nova S Schiene93/42 boso nova S Stativ93/42 boso nova S Tisch93/42 boso nova S Wand93/42 boso profitest2 refs93/42 boso roid I2 refs93/42 boso roid II2 refs93/42 boso solid2 refs93/42 boso varius2 refs93/42 boso varius privat93/42	I 93/42	Website EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Central Monitoring System FTS-6 Central Monitoring System MFM-CMS Central Monitoring System MFM-CNS2 refs FECG1 Fetal & Maternal Monitor F122 refs 23 others Fetal & Maternal Monitor F152 refs Fetal & Maternal Monitor F63 refs Fetal Monitor F22 refs Finger Oximeter H103 refs Patient Monitor CX103 refs Patient Monitor elite V53 refs Patient Monitor iM20 Patient Monitor iV100 Patient Monitor iV123 refs Patient Monitor iX103 refs Patient Monitor M503 refs Patient Monitor M83 refs Patient Monitor Neptune Patient Monitor RespArray Patient Monitor X103 refs Pulse Oximeter H100B2 refs Telemetry Monitor iT302 refs Telemetry Transmitter FT20 Telemetry Transmitter iT20 Vital Signs Monitor ES3 Vital Signs Monitor iHM3s3 refs Vital Signs Monitor iM3 Vital Signs Monitor M33 refs	IIa, IIb MDR	EUDAMED record Report an error
Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Türkiye	Sümer SM-ASE 2093/42 Sümer SM-ASE 3093/42 Sümer SM-ASE 5093/42 Sümer SM-IK 650 L93/42 Sümer SM-IK 1050 L93/42 21 others Sümer SM-IK 200 L93/42 Sümer SM-IK 250 L93/42 Sümer SM-IK 350 L93/42 Sümer SM-IK 450 L93/42 Sümer SM-IK 550 L93/42 Sümer SM-IK 750 L93/42 Sümer SM-IK 850 L93/42 Sümer SM-IK 950 L93/42 Sümer SM-TKI 200 L93/42 Sümer SM-TKI 100 L93/42 Sümer SM-TKI 1050 L93/42 Sümer SM-TKI 150 L93/42 Sümer SM-TKI 250 L93/42 Sümer SM-TKI 350 L93/42 Sümer SM-TKI 450 L93/42 Sümer SM-TKI 50 L93/42 Sümer SM-TKI 550 L93/42 Sümer SM-TKI 650 L93/42 Sümer SM-TKI 750 L93/42 Sümer SM-TKI 850 L93/42 Sümer SM-TKI 950 L93/42	I 93/42	EUDAMED record Report an error
Чек Пойнт Ар енд Ди ООД	Bulgaria	Checkpoint Cardio CPC12 12 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 12 Channel ECG Pacth (10 pieces)93/42 Checkpoint Cardio CPC12S 12 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 12 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC12S 2 Channel and 12 Channel ECG Pacth (10 pieces)93/42 21 others Checkpoint Cardio CPC12S 2 Channel and 12 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 2 Channel and 12 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC12S 2 Channel and 3 Channel ECG Pacth (10 pieces)93/42 Checkpoint Cardio CPC12S 2 Channel and 3 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 2 Channel and 3 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC12S 2 Channel ECG Pacth (10 pieces)93/42 Checkpoint Cardio CPC12S 2 channel ECG patch93/42 Checkpoint Cardio CPC12S 2 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC12S 2 Channel, 3 Channel and 12 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 2 Channel, 3 Channel and 12 Channel ECG Patch (10 pieces)93/42 Checkpoint Cardio CPC12S 2 Channel, 3 Channel and 12 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC12S 3 Channel and 12 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 3 Channel and 12 Channel ECG Patch (10 pieces)93/42 Checkpoint Cardio CPC12S 3 Channel and 12 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC12S 3 Channel ECG Patch93/42 Checkpoint Cardio CPC12S 3 Channel ECG Patch (10 pieces)93/42 Checkpoint Cardio CPC12S 3 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC1S 3 Channel ECG Patch93/42 Checkpoint Cardio CPC1S 3 Channel ECG Patch (10 pieces)93/42 Checkpoint Cardio CPC1S 3 Channel ECG Patch (5 pieces)93/42 Checkpoint Cardio CPC3 3 Channel ECG Patch93/42	IIb 93/42	Website EUDAMED record Report an error
Shenzhen Everbest Machinery lndustry EU representative : Lotus NL B.V. (Netherlands)	China	Electronic Blood Pressure Monitor BP-106 Electronic Blood Pressure Monitor BP-106H Electronic Blood Pressure Monitor BP-108 Electronic Blood Pressure Monitor BP-108B Electronic Blood Pressure Monitor BP-108H 20 others Electronic Blood Pressure Monitor BP-120 Electronic Blood Pressure Monitor BP-120H Electronic Blood Pressure Monitor BP-80 Electronic Blood Pressure Monitor BP-80B Electronic Blood Pressure Monitor BP-80H Electronic Blood Pressure Monitor BP-82 Electronic Blood Pressure Monitor BP-90 Electronic Blood Pressure Monitor BP-90H Electronic Blood Pressure Monitor BP-90S Electronic Blood Pressure Monitor U60CH Electronic Blood Pressure Monitor U80E Electronic Blood Pressure Monitor U80EH Pulse Oximeter OX-68 Pulse Oximeter OX-68H Pulse Oximeter OX-97 Pulse Oximeter OX-97H Pulse Oximeter OX-98 Pulse Oximeter OX-98B Pulse Oximeter OX-99 Pulse Oximeter OX-99H	IIa MDR	EUDAMED record Report an error
Sino Medical-Device Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	H20DL93/42 H20DL, H20SL, H20DS, H20SS SN-1500H93/42 SN-1600V93/42 SN-1800V93/42 44 others SN-1800VR93/42 SN-50C693/42 SN-50C6693/42 SN-50C66T93/42 SN-50C6T93/42 SN-50F693/42 SN-50F6693/42 SN-50T6693/42 SN-600N93/42 SN-600NR, SN-600N, SN-800ND1, SN-800ND23 refs SN-A193/42 SN-A2T93/42 SN-C2T93/42 SN-C9T3 refs SN-D2T93/42 SN-H1093/42 SN-M293/42 SN-N193/42 SN-S193/42 H20DS93/42 (no longer marketed) H20SS93/42 (no longer marketed) SN-1500HR93/42 (no longer marketed) SN-1600VR93/42 (no longer marketed) SN-2000V93/42 (no longer marketed) SN-2000VR93/42 (no longer marketed) SN-50C66R93/42 (no longer marketed) SN-50C66TR93/42 (no longer marketed) SN-50C66TS93/42 (no longer marketed) SN-50C66TSR93/42 (no longer marketed) SN-50C6A93/42 (no longer marketed) SN-50F66R93/42 (no longer marketed) SN-50F6A93/42 (no longer marketed) SN-50T66R93/42 (no longer marketed) SN-A1A93/42 (no longer marketed) SN-A293/42 (no longer marketed) SN-C193/42 (no longer marketed) SN-D193/42 (no longer marketed) SN-D1A93/42 (no longer marketed) SN-D293/42 (no longer marketed) SN-M193/42 (no longer marketed) SN-N293/42 (no longer marketed) SN-S1A93/42 (no longer marketed) SN-S293/42 (no longer marketed) SN-S2A93/42 (no longer marketed)	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Guangdong Biolight Meditech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Central Monitoring System BioVision2 refs Electronic Sphygmomanometer WBP201, WBP2022 refs Electronic Sphygmomanometer WBP301, WBP3022 refs Fingertip Pulse Oximeter M70, M70A, M70B, M70C, M70D3 refs Handheld monitor M850 19 others Handheld monitor M860 Handheld monitor M880 Infusion Pump BioFusion M500, BioFusion M500 Ex, BioFusion M500 Pro, Evadrop V103 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 V3 refs Infusion Supervision System BioFusion DS100, BioFusion DS100T, BioFusion DS100Pro, BioFusion DS100T Pro, CODAN 200 D, CODAN 400 DD3 refs Patient monitor G10, G12, G15, G10A, G12A, G15A3 refs Patient monitor M10, Truscope M102 refs Patient monitor M1000, TRUSCOPE touch mini2 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 183 refs Patient monitor Q3, Q5, Q7, TRUSCOPE Ultra Q3, TRUSCOPE Ultra Q5, TRUSCOPE Ultra Q7, PG S30, PG S50, PG S70, LM73 refs Patient monitor S10, S10A2 refs Patient monitor S12, S12A, LM123 refs Pulse Oximeter M800 Syringe Pump BioFusion M300, BioFusion M300 Ex, BioFusion M300 Pro, Evadrop V203 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 S3 refs Vital signs monitor V6 Vital signs monitor V9	IIa, IIb MDR	Website EUDAMED record Report an error
Guangdong Transtek Medical Electronics FDA EU representative : MDSS GmbH (Germany) and 1 other	China	Alfacheck SMART VOICE BBZ32-AA01,BBZ32-AB01,BBZ32-BB01,BBZ32-DA01,BBZ32-DB013 refs Alfacheck TMB-1581-ZY3 refs Alvita AC2242-103 refs Alvita TMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 22833 refs Beurer LS802-GP2 refs 19 others Blood Pressure Monitor BB2284-AE01 Blood Pressure Monitor BBY31-BT1, BBY31-1, BBY36-BT1, BBY36-13 refs Blood Pressure Monitor TMB-2296-B2 refs Blood Pressure Monitor TMB-1490-CS93/42 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-A3 refs Boots BBY31-BT, BBY31, BBY36-BT, BBY36 BRAUN BUA6400CEME, BUA6400WE2 refs CELIMED CL3 TMB-2084-N93/42 Checkme3 refs Corsano TMB-2084-A93/42 ETA TMB-1583-BS93/42 EZVIZ CS-WBP1-E FLEMING TMB-1872-A93/42 MEDISANA TMB-2287-BK ProBP 2000 Digital Blood Pressure Device2 refs TeleRPM TMB-2092-G2 refs TRANSTEK TMB-1491-AS93/42 TRANSTEK TMB-197093/42 Withings BPM Pro 2 WPM072 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	AURORA 1093/42 AURORA 10s93/42 AURORA 1293/42 AURORA 12s93/42 AURORA 893/42 19 others AURORA 8s93/42 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 SONOSAT-F01LP93/42 SONOSAT-F01LT93/42 SONOSAT-F01LW93/42 SONOSAT-F01P93/42 SONOSAT-F01W93/42 SONOSAT-F02LP93/42 SONOSAT-F02LT93/42 SONOSAT-F02LW93/42 SONOSAT-F02P93/42 SONOSAT-F02T93/42 SONOSAT-F02W93/42 SONOSAT-W01LP93/42 SONOSAT-W01LT93/42 SONOSAT-W01LW93/42 SONOSAT-W01P93/42 SONOSAT-W01T93/42 SONOSAT-W01W93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
JOYTECH Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Arm type Fully Automatic Digital Blood Pressure Monitor BM-23013 refs Arm type Fully Automatic Digital Blood Pressure Monitor DBP-61733 refs Arm-Type Fully Automatic Blood Pressure Monitor Aposán DBP-130793/42 Arm-Type Fully Automatic Blood Pressure Monitor Zydus DBP-120993/42 Arm-Type Fully Automatic Blood Pressure Monitor DBP-130393/42 17 others Arm-Type Fully Automatic Blood Pressure Monitor DBP-1307b2 refs Arm-Type Fully Automatic Blood Pressure Monitor DBP-22083 refs Arm-Type Fully Automatic Blood Pressure Monitor DBP-6179-P3 refs Arm-Type Fully Automatic Blood Pressure Monitor DBP-6279B3 refs Arm-Type Fully Automatic Blood Pressure Monitor DBP-6279B-P3 refs Arm-Type Fully Automatic Blood Pressure Monitor DBP-6679B、DBP-6675B、DBP-6673B2 refs Arm-Type Fully Automatic Digital Blood Pressure Monitor Dr. Line DBP-131993/42 Blood Pressure Monitor JOCCAPHARMA DBP-135193/42 Fingertip Pulse Oximeter3 refs Fingertip Pulse Oximeter XM-101 Wrist-Type Fully Automatic Blood Pressure Monitor BM10063 refs Wrist-Type Fully Automatic Blood Pressure Monitor DBP-211693/42 Wrist-Type Fully Automatic Digital Blood Pressure Monitor Aposán DBP-220893/42 Wrist-Type Fully Automatic Digital Blood Pressure Monitor Dr. Line DBP-222093/42 Wrist-Type Fully Automatic Digital Blood Pressure Monitor Zydus DBP-220693/42 Wrist-type Fully Automatic Digital Blood Pressure Monitor DBP-21E8b Wrist-type Fully Automatic Digital Blood Pressure Monitor DBP-8288B	IIa MDR, 93/42	info@sejoy.com EUDAMED record Report an error
Microlife FDA EU representative : Microlife UAB (Lithuania)	Taiwan	BP3GK1-4E93/42 BP3GT1-6Y93/42 BP3KD1-3N93/42 BP3MS1-4N93/42 Microlife3 refs 17 others Microlife BP3GI1-3E93/42 Microlife BP3GQ1-1P93/42 Microlife BP3GQ1-3P93/42 Microlife BP3GR1-1P93/42 Microlife BP3GT1-6F93/42 Microlife BP3GT1-6Y93/42 Microlife BP3GU1-3E93/42 Microlife BP3GU1-8Y93/42 Microlife BP3GX1-3A93/42 Microlife BP3GX1-3X93/42 Microlife BP3GX1-5N93/42 Microlife BP3MS1-2M93/42 Microlife BP3MX1-493/42 Microlife BP3MZ1-1A93/42 Microlife TWIN200 ABI93/42 Microlife TWIN200 AFS93/42 TWIN10093/42	IIa MDR, 93/42	info@microlife.com.tw EUDAMED record Report an error
Xuzhou Yongkang Electronic Science Technology FDA EU representative : Prolinx GmbH (Germany)	China	Arm Type Electronic Blood Pressure Monitor YK-IBPA13 refs BIOPAX3 refs Endostall9 refs K193/42 Multiparameter Patient Monitor E1593/42 17 others Multiparameter Patient Monitor M893/42 Multiparameter Patient Monitor YK-810B93/42 Wrist Type Blood Pressure Monitor YK-BPW12 refs YK-8000B93/42 YK-8000C93/42 YK-820A93/42 YK-820B93/42 YK-84B93/42 YK-84C93/42 YK-BPA193/42 YK-BPA293/42 YK-BPA393/42 YK-BPA493/42 YK-BPW193/42 YK-BPW293/42 YK-BPW393/42 YK-BPW493/42	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Sino-Hero(Shenzhen) Bio-Medical Electronics EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Handheld monitor SM5093/42 Handheld monitor SM8093/42 NIBP cuff SH0118 Patient monitor AcuitsignM393/42 Patient monitor AcuitsignM593/42 16 others Patient monitor AcuitsignM693/42 Patient monitor H593/42 Patient monitor H893/42 Patient monitor iS1093/42 Patient monitor iS10Express93/42 Patient monitor iS1593/42 Patient monitor mTouch693/42 Patient monitor mTouch893/42 Patient monitor S1293/42 Patient monitor S60Vista93/42 Patient monitor S8093/42 Patient monitor S9093/42 Patient monitor S90Express93/42 Pulse Oximeter S693/42 Pulse Oximeter S893/42 Pulse Oximeter S993/42	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Viatomtech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Babytone PO5, PO5-1, PO5-2, PO5-33 refs BP193/42 BP1S93/42 Checkme BP2A Checkme Lite93/42 16 others Checkme Plus93/42 Checkme Pod93/42 Checkme Pro93/42 LEPU MEDICAL BP3, BP3D, BP3K, HDM3, HDM3D, HDM3K3 refs LEPU MEDICAL LeRes-S, LeRes-A, LeRes-B, LeRes-C, R100, R10, R200, R203 refs LEPU MEDICAL PF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B13 refs LEPU MEDICAL PO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-S3 refs PF-10AW93/42 PO1B93/42 PO493/42 PO693/42 Viatom Oxiband、Oxiduck、Oximax、Oxiduckm、Oxiultra、Oxiultra01、Oxiducku、Oxiduckp3 refs Viatom PO6、PO6A、 PO1、 PO1B2 refs Viatom VTM01、VTM01A、VTM01B2 refs VTM01A93/42 Wellue PO6B、PO6C2 refs	IIa MDR, 93/42	EUDAMED record Report an error
Dong Guan City Good Health Electronic Technology FDA EU representative : Share info GmbH (Germany)	China	HK-60193/42 HK-60293/42 HK-60393/42 HK-60593/42 HK-60693/42 15 others HK-60793/42 HK-60893/42 HK-60993/42 HK-61093/42 HK-61193/42 HK-80193/42 HK-80293/42 HK-80393/42 HK-80593/42 HK-80693/42 HK-80793/42 HK-80893/42 HK-80993/42 HK-81093/42 HK-81193/42	IIa 93/42	EUDAMED record Report an error
Shenzhen Changkun Technology FDA EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany)	China	CHANGKUN CK-101S93/42 CHANGKUN CK-102S93/42 CHANGKUN CK-A12093/42 CHANGKUN CK-A13693/42 CHANGKUN CK-A13893/42 15 others CHANGKUN CK-A13993/42 CHANGKUN CK-A15593/42 CHANGKUN CK-A15693/42 CHANGKUN CK-A15893/42 CHANGKUN CK-A16893/42 CHANGKUN CK-W11893/42 CHANGKUN CK-W13293/42 CHANGKUN CK-W13393/42 CHANGKUN CK-W13593/42 CHANGKUN CK-W17593/42 CHANGKUN CK-W17693/42 CHANGKUN CK-W35593/42 CHANGKUN CK-W35693/42 CHANGKUN CK-W35893/42 Z1203020501 CK-10193/42	IIa 93/42	EUDAMED record Report an error
Shenzhen Creative Industry FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) and 1 other	China	AIVIEW V10、PH10、LeMonitor V10、AIVIEW V12、PH12、LeMonitor V123 refs AIView VS、LeMonitor VS、MS10、VS103 refs AIView VX、AT10、LeMonitor VX、MT103 refs AP-10、PC-68B2 refs AP-20 15 others Fingertip Oximeter PC-60A93/42 K10、K12、K153 refs Novama Expert® Ręczny Pulsoksymetr HPOXY, model PC-66A, wariant S1 SP-20、PC-66A2 refs PC-102 PC-3000、Deluxe-70 PC-303 PC-60B1、POD-3、PC-60F、PC-60FW3 refs PC-60B、POD-2、POD-2W3 refs PC-60D2 PC-60D32 refs PC-60E、PC-60N、PC-60NW3 refs PC-66B、PC-66B1、PC-66B23 refs PC-900B93/42 PC-900、PC-900PRO POD-1、POD-1W2 refs UP-7000、Advance-120	IIa, IIb MDR, 93/42	Website info@creative-sz.com EUDAMED record Report an error
Shenzhen Witleaf Medical Electronics FDA EU representative : Zug Medical Systems (France)	China	Children's Respiration Monitor ChARM Fingertip Pulse Oximeter2 refs Fingertip Pulse Oximeter WIT-S20093/42 Fingertip Pulse Oximeter WIT-S40093/42 Handheld Pulse Oximeter WIT-S100 14 others Handheld Pulse Oximeter WIT-S30093/42 Patient Monitor E103 refs Patient Monitor SATP-MC93/42 Patient Monitor SATP-OX93/42 Patient Monitor SATP-SE93/42 Patient Monitor SATP-SI93/42 Patient Monitor SPLF-MC93/42 Patient Monitor SPLF-NP93/42 Patient Monitor SPLF-OX93/42 Patient Monitor SPLF-SE93/42 Patient Monitor XH-30A3 refs Patient Monitor XH-60A93/42 Patient Monitor XH-60D93/42 Rapid Intervention Capnograph2 refs	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Yuyue FDA EU representative : Metrax GmbH (Germany)	China	Electronic blood pressure monitor YE630CR Electronic blood pressure monitor YE660D, YE610D, YE610F, YEC30, YEC31, YEC603 refs Electronic blood pressure monitor YE670A, YE666A, YE666B, YES60, YE690C, YE690D3 refs Electronic blood pressure monitor YE670CR, YE650AR2 refs Electronic blood pressure monitor YE680B,YE660F,YE660E,YE620B3 refs 14 others Electronic blood pressure monitor YE8300B Positive Airway Pressure Units ET3, ET5, ET5 Elite, ET5 Pro, ET6, ET6 Elite3 refs Positive Airway Pressure Units Pocket X, Pocket Y, Pocket E, Pocket S3 refs Positive Airway Pressure Units YH-350, YH-5503 refs Positive Airway Pressure Units YH-360, YH-560, YH-5803 refs Positive Airway Pressure Units YH-450, YH-4803 refs Positive Airway Pressure Units YH-680A, YH-680B, YH-690A, YH-690B3 refs Positive Airway Pressure Units YH-720, YH-725, YH-7303 refs Positive Airway Pressure Units YH-820, YH-825, YH-830, YH-820Auto, YH-825Auto3 refs Positive Airway Pressure Units YH-920, YH-925, YH-930, YH-920Auto, YH-925Auto, YH-920ASV, YH-925ASV, YH-930Lab3 refs YE650D, YE650A YE8800AR,YE8800CR2 refs YE990, YE991, YE992, YE993 YUWELL® Finger Pulse Oximeter YX102, YX105, YX106, YX110,YX301, YX306, YX3103 refs	IIa MDR	qa.yuwell@yuyue.com.cn EUDAMED record Report an error
Avatajhiz EU representative : Heiltronic (Germany)	Iran	ati Care ati care Adult 1880D ati Care Adult 1880NS ati care Adult 1880S ati Care Child 1882D 13 others ati Care Child 1882NS ati Care Larg Adult 1879D ati care Larg Adult 1879NS ati Care Larg Adult 1879S ati Care Neonate 1883D ati Care Neonate 1883NS ati Care Neonate 1883S ati Care NewBorn 1884S ati Care Semi Adult 1881D ati Care Semi Adult 1881NS ati Care Semi Adult 1881S atiCare ATITRS-2 atiCare ATTRS-1	I, IIb MDR	Website EUDAMED record Report an error
Hoffrichter	Germany	LAVI 30 9LV40193/42 LAVI 35 9LV40593/42 LAVI 40 9LV40293/42 LAVI 45 9LV40493/42 Point 3 AutoCPAP 5CPG1093/42 13 others Point 3 AutoCPAP 5CPG2093/42 Point 3 AutoCPAP 5CPG4093/42 POINT 3 AutoCPAP 5CPG6093/42 Point 3 CPAP 5CPG0093/42 Point 3 CPAP 5CPG3093/42 Point 3 CPAP 5CPG5093/42 POINT 3 CPAP 5CPG7093/42 TREND III AutoBILEVEL S 5CPD6193/42 TREND III AutoBILEVEL ST 5CPD5193/42 TREND III AutoCPAP 5CPD1193/42 TREND III BILEVEL S 5CPD4193/42 TREND III BILEVEL ST 5CPD3193/42 TREND III CPAP 5CPD2193/42	IIa 93/42	Website info@hoffrichter.de EUDAMED record Report an error
Shanghai Berry Electronic Tech FDA EU representative : Prolinx GmbH (Germany)	China	Patient Monit PM610093/42 Patient Monitor PM6100A93/42 Patient Monitor PM6100B93/42 Patient Monitor PM6100C93/42 Pulse Oximeter BM100093/42 13 others Pulse Oximeter BM1000A93/42 Pulse Oximeter BM1000B93/42 Pulse Oximeter BM1000C93/42 Pulse Oximeter BM1000D93/42 Pulse Oximeter BM1000E93/42 Pulse Oximeter BM200093/42 Pulse Oximeter BM2000A93/42 Pulse Oximeter BM2000B93/42 Pulse Oximeter BM2000C93/42 Pulse Oximeter BM2000D93/42 Pulse Oximeter BM2000E93/42 Pulse Oximeter BM2000F93/42 Pulse Oximeter OSAsense S1893/42	IIa 93/42	Radepartment@shberrymed.com EUDAMED record Report an error
Comdek EU representative : MedNet EC-REP IIb GmbH (Germany)	Taiwan	e-Angel Pulse Oximater MD-651P93/42 e-Angel Pulse Oximater MD-653P93/42 i-Oximeter MD-620P93/42 Portable Capnography MD-663P93/42 Portable Oxi-Capnography MD-660P93/42 31 others Portable Oxi-Capnography MD-667P93/42 Portable Oxi-Capnometer MD-661P93/42 Portable Palme Pulse Oximeter MD-680P93/42 Portable Patient Monitor MD-80093/42 Portable Patient Monitor MD-81093/42 Portable Patient Monitor MD-83093/42 Portable Patient Monitor MD-85093/42 Portable Pulse Oximeter MD-600P93/42 Portable Pulse Oximeter MD-610P93/42 Portable Pulse Oximeter MD-630P93/42 Portable Pulse Oximeter MD-670P93/42 Traveler Oximeter MD-650P93/42 intelligent Patient Monitor93/42 (no longer marketed) intelligent Patient Monitor MD-90093/42 (no longer marketed) intelligent Patient Monitor MD-91093/42 (no longer marketed) intelligent Patient Monitor MD-92093/42 (no longer marketed) intelligent Patient Monitor MD-93093/42 (no longer marketed) intelligent Patient Monitor MD-95093/42 (no longer marketed) intelligent Patient Monitor MD-96093/42 (no longer marketed) intelligent Patient Monitor MD-98093/42 (no longer marketed) intelligent Patient Monitor MD-99093/42 (no longer marketed) Portable Capnography MD-665P93/42 (no longer marketed) Portable Capnography MD-669P93/42 (no longer marketed) Portable Capnometer MD-662P93/42 (no longer marketed) Portable Oxi-Capnography MD-668P93/42 (no longer marketed) Portable Patient Monitor MD-82093/42 (no longer marketed) Portable Patient Monitor MD-86093/42 (no longer marketed) Portable Patient Monitor MD-87093/42 (no longer marketed) Portable Patient Monitor MD-88093/42 (no longer marketed) Portable Pulse Oximeter MD-655P93/42 (no longer marketed) Traveler Oximeter MD-652P93/42 (no longer marketed)	IIb 93/42	info@comdek.com EUDAMED record Report an error
Shenzhen Bsx Technology Electronics FDA EU representative : MedNet EC-REP GmbH (Germany)	China	AC-43793/42 AC-908093/42 BSX253,BSX233,BSX251,BSX255B,BSX238B,BSX231 BSX31293/42 BSX31393/42 13 others BSX31593/42 BSX32293/42 BSX32593/42 BSX51393/42 BSX51693/42 BSX52593/42 BSX55893/42 BSX561,BSX593,BSX505,BSX508,BSX527,BSX595,BSX553,BSX516,BSX515,BSX525,BSX512,BSX556,BSX595E,BSX568 BSX57993/42 BSX58393/42 BSXIN BSX57993/42 BSXIN BSX59593/42 Arm Type Electronic Blood Pressure Monitor BSX-51393/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Hawkmedical EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Hawk-fw193/42 hawk-i193/42 hawk-s193/42 HAWK-WS193/42 HAWK-WS293/42 12 others Hawkmed N300-H3 refs Hawkmed N300-V3 refs HK-10093/42 HK-100I93/42 HK-100II93/42 HK-30093/42 HK-40093/42 HK-400I93/42 HK-400II93/42 HK-400III93/42 Infusion Pump InnoFusion IF-50, 908 V, 907 V3 refs Infusion Workstation InnoFusion IF-800, 500 D2 refs	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Meditech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Ambulatory Blood Pressure Monitor Echo8093/42 Automated External Defibrillator Defi593/42 Automated External Defibrillator Defi5S93/42 Automated External Defibrillator Defi5S eXtra93/42 Automated External Defibrillator Defi5S Pro93/42 12 others Automated External Defibrillator Defi693/42 Blood Pressure Monitor MD05X93/42 Blood Pressure Monitor MD06X93/42 Defibrillator Monitor Defi Xpress93/42 Defibrillator Monitor Defi893/42 Patient Monitor MD9000S93/42 Patient Monitor MD90893/42 Patient Monitor Oxima93/42 Pulse Oximeter Fos2 Plus93/42 Pulse Oximeter Oxy93/42 Pulse Oximeter Oxyo Pro93/42 Pulse Oximeter OxyT93/42	IIa, IIb 93/42	Website sales@meditech.cn EUDAMED record Report an error
Merit FDA EU representative : Merit Medical Ireland Ltd (Ireland)	Singapore, United States	basixCOMPAK™27 refs93/42 basixTOUCH™4 refs93/42 Clipper™3 refs Critikit™5 refs93/42 Floswitch™93/42 12 others Merit Medical®73 refs Merit Medical® Initial Release93/42 Merit Medical® Safedraw™2 refs93/42 Meritrans DTXPlus®136 refs93/42 Meritrans DTXPlus® 1088445043562293/42 Meritrans®3 refs93/42 Meritrans® Initial Release8 refs93/42 R.O.S.E™93/42 Safedraw™129 refs93/42 Safedraw™ Meritrans DTXPlus®10 refs93/42 TRAM®5 refs93/42 TRAM®P8 refs93/42	I, IIa MDR, 93/42	Website udiadmin@merit.com EUDAMED record Report an error
Shenzhen Med-link Electronics Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ESM20193/42 Micro Capnometer CA6093/42 NIBP cuff and accessories Y000DA13 refs Pulse Oximeter AM80193/42 Sterile Disposable Blood Pressure Transducer X0020C93/42 12 others Sterile Disposable Blood Pressure Transducer X0046A93/42 Sterile Disposable Blood Pressure Transducer X0046B93/42 Sterile Disposable Blood Pressure Transducer X0046C93/42 Sterile Disposable Blood Pressure Transducer X0046D93/42 Sterile Disposable Blood Pressure Transducer X0046E93/42 Sterile Disposable Blood Pressure Transducer X0046F93/42 Sterile Disposable Blood Pressure Transducer X0046G93/42 Sterile Disposable Blood Pressure Transducer X0046J93/42 Sterile Disposable Blood Pressure Transducer X0046K93/42 Sterile Disposable Blood Pressure Transducer X0116A93/42 Sterile Disposable Blood Pressure Transducer X0118A93/42 X0046A93/42	I, IIa, IIb MDR, 93/42	Website sales@med-linket.com EUDAMED record Report an error
A.M.I. Italia FDA	Italy	GeoSaver automatico 360J93/42 GeoSaver D semiautomatico 200J93/42 GeoSaver D semiautomatico 360J93/42 GeoSaver P Dual mode 200J93/42 GeoSaver P Dual mode 360J93/42 11 others GeoSaver semiautomatico 200J93/42 GeoSaver semiautomatico 360J93/42 Saver One D S1 SaverOne D S1 semiautomatico 200J93/42 Saver One D SaverOne D semiautomatico 200J93/42 Saver One D SaverOne D semiautomatico 360J93/42 Saver One S1 SaverOne S1 automatico 200J93/42 Saver One S1 SaverOne S1 automatico 360J93/42 Saver One S1 SaverOne S1 semiautomatico 200J noLCD93/42 Saver One S1 SaverOne S1 semiautomatico 360J noLCD93/42 Saver One SaverOne automatico 360J93/42 Saver One SaverOne semiautomatico 360J93/42	IIb 93/42	Website info@amiitalia.com EUDAMED record Report an error
AViTA FDA EU representative : MDSS GmbH (Germany)	Taiwan	0075N93/42 Arm Type Blood Pressure Monitor NA0903 refs AViTA BPM6093/42 AViTA BPM6193/42 AViTA BPM6393/42 11 others AViTA BPM6893/42 AViTA BPM8293/42 BPM6393/42 BPM65B93/42 BPM8293/42 BPM8393/42 BPW2293/42 Pulse oximeter SP643 refs Tensiomètre au poignet BC5193/42 Wrist Type Blood Pressure Monitor BPM2993/42 Wrist Type Blood Pressure Monitor BPW263 refs	IIa MDR, 93/42	Website Info@avita.com.tw EUDAMED record Report an error
Covidien FDA EU representative : Medtronic B.V. (Netherlands)	United States	10076644 NELLCOR SPO2 MODULE W CABLEX193/42 DS100A DURASENSOR ADT DIGIT X193/42 INVOS 7100 Patient Monitor Preamplifier INVOS PM7100 ADULT RSO2 SENSOR2 refs INVOS PM7100 Patient Monitor 11 others INVOS PM7100 RE-USABLE SENSOR CABLE3 refs INVOS rSO2 preamplifier INVOS rSO2 micro-module PMC71VP-GE Nellcor NS Disposable Sensors Nellcor NS Reusable Sensor Accessories3 refs Nellcor NS Snsr Acc for Reus/Dis. Snsrs3 refs OxySoft Neonatal-Adult SpO2 sensor3 refs PMC10GE120N;PMC10GE360N2 refs PMC10N-SF PMC10NCH-GE Puritan Bennett 980 Ventilator System3 refs	I, IIb MDR, 93/42	EUDAMED record Report an error
Grandway FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Digital Automatic Blood Pressure Monitor - MD19103 refs MD240093/42 MD268093/42 MD311093/42 MD330093/42 11 others MD331093/42 MD350093/42 MD360093/42 MD418093/42 MD41A093/42 MD522093/42 MD530093/42 MD53B193/42 MD545193/42 MD547093/42 MD600093/42	IIa MDR, 93/42	Website sales@grandway.com.hk EUDAMED record Report an error
Shanghai Kohden Medical Electronic Instrument EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	China	BSM-2530 BSM-2532 BSM-2535 BSM-2560 BSM-2562 11 others BSM-2565 SVM-7130 SVM-7160 SVM-7501 SVM-7502 SVM-7503 SVM-7504 SVM-7521 SVM-7522 SVM-7523 SVM-7524	IIb MDR	Website 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-B93/42 Yamind DM26-20A93/42 Yamind DM26-20C93/42 Yamind DM26-25S93/42 11 others Yamind DM26-25T93/42 Yamind DM26-30T93/42 Yamind DM28-20A-W93/42 Yamind DM28-20A-WP2 refs93/42 Yamind DM28-20SA-G93/42 Yamind DM28-20ST-G93/42 Yamind DM28-25SA-BP93/42 Yamind DM28-25ST-BP93/42 Yamind DM28-30ST-B93/42 Yamind DM28-30ST-BP93/42 Yamind DM28-30STA-BP93/42	IIa MDR, 93/42	EUDAMED record Report an error
Schiller FDA EU representative : SCHILLER Medizintechnik GmbH (Germany)	France, Switzerland	ARGUS PRO LifeCare 293/42 ARGUS PRO LifeCare 2 - APLC2 GSM-version93/42 BP-200 Plus93/42 BP-200 plus (Base device SpO2)93/42 BPCD18L BPCV14XS - Velcro cuff XS3 refs 11 others EASY PULSE Base device IP33 version EASY PULSE Base Device IP43 Version (modified)2 refs FRED Easyport plus - AED First/Semi-AED2 refs93/42 FRED Easyport plus - AED MANUAL93/42 SCHILLER 1-127-990193/42 SCHILLER 1-58-910093/42 SCHILLER 1-58-950193/42 SCHILLER 1-58-950293/42 SCHILLER 1-58-990193/42 SCHILLER FRED PA-1 DSA93/42 Tempus LS93/42 FRED Easyport93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	Website info@schiller.ch EUDAMED record Report an error
Barotek Tibbi Malzeme Medikal Urunler Sualti Dalis Ekipmanlari San Ve Tic Sti	Türkiye	Barotech MONO93/42 Barotech MULTİ 1093/42 Barotech MULTİ 1293/42 Barotech MULTİ 1493/42 Barotech MULTİ 1693/42 10 others Barotech MULTİ 493/42 Barotech MULTİ 693/42 Barotech MULTİ 893/42 Barotech MULTİ DK 150093/42 Barotech MULTİ DK 160093/42 Barotech MULTİ DK 170093/42 Barotech MULTİ DK 180093/42 Barotech TETRAKTİS 1293/42 Barotech TETRAKTİS 1693/42 Barotech TETRAKTİS 893/42	IIb 93/42	Website info@barotech.com.tr EUDAMED record Report an error
Emtel	Poland	DefiMax AED93/42 DefiMax biphasic93/42 DefiMax mobile93/42 DefiMax Plus93/42 FX 2000P type LCD1293/42 10 others FX 3000 type LCD1593/42 FX 3000 type LCD1793/42 FX 3000 type LCD1993/42 FX 3000 type LCD2193/42 FX 3000MD type LCD1593/42 FX 3000MD type LCD1793/42 FX 3000MD type LCD1993/42 FX 3000MD type LCD2193/42 FX 3000P type LCD1293/42 FX 3000T93/42	IIb 93/42	Website EUDAMED record Report an error
Mediana FDA EU representative : Obelis s.a. (Belgium)	South Korea	D1007 refs93/42 D50017 refs93/42 D70045 refs93/42 HeartOn A15-G44 refs93/42 HeartOn A16-DF7 refs93/42 10 others HeartOn A16-DS8 refs93/42 HeartOn A16-GF4 refs93/42 HeartOn A16-GS5 refs93/42 M2012 refs93/42 M304 refs93/42 M329 refs93/42 M409 refs93/42 M502 refs93/42 V1015 refs93/42 V203 refs93/42	IIb 93/42	Website EUDAMED record Report an error
Canespa FDA	Italy	CRONO 50 SC SC pumps CRONO LECIG LCG pumps CRONO ND ND pumps2 refs CRONO P CRONO PAR3 refs 9 others CRONO PAR4 20 & CRONOBELL ADAPTER PAR pumps with CRONOBELL ADAPTER2 refs CRONO PAR4 20 & CRONOJET PAR pumps with CRONOJET CRONO S-PID 100 & CRONOFILL & CRONOJET PID pumps with CRONOFILL and CRONOJET3 refs CRONO S-PID 100 & CRONOFILL PID pumps with CRONOFILL3 refs CRONO S-PID 100 PID pumps3 refs CRONO S-PID FRM pumps2 refs CRONO SC SCT pumps CRONO THA pumps2 refs INFONDE INF pumps	IIb MDR	Website quality@canespa.it EUDAMED record Report an error
GS Elektromedizinische Geräte G. Stemple	Germany	06100.22 corpuls aed (fully automatic) (ext.)93/42 06101.22 corpuls aed (fully automatic) (ext.)93/42 Arm corpuls cpr 00008 corpuls aed (fully automatic)2 refs93/42 corpuls aed (fully automatic) with emergency call93/42 9 others corpuls aed (Halbautomat) mit GSM-Notruf93/42 corpuls aed (semi automatic)2 refs93/42 corpuls aed (semi automatic) with emergency call93/42 corpuls aed (Vollautomat) (ext.) mit GSM-Notruf 06101.21 corpuls aed (fully automatic)(ext) with emercency call93/42 External Battery Charger corpuls cpr 00010 Li-Ion Rechargeable Battery 28.8V 3000mAh 86.4Wh 000272 refs Quadboard 000073 refs Stamp cpr (long) 000152 refs Stamp extension cpr (application scoopboard) 00005	I, IIb MDR, 93/42	regulatory@corpuls.com EUDAMED record Report an error
Hedymed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Infusion Management System(central workshop) HDIS 5093/42 Infusion Management System(Control panel) HDIS 5093/42 Infusion Management System(Simple panel) HDIS 5093/42 Infusion Pump i593/42 Infusion Pump i5 plus93/42 9 others Infusion Pump i793/42 Infusion Pump ip-193/42 Infusion Pump ip-393/42 Syringe Pump s593/42 Syringe Pump s5 plus93/42 Syringe Pump s793/42 Syringe Pump sp-193/42 Syringe Pump sp-393/42 Syringe Pump TCI-793/42	IIb 93/42	Website EUDAMED record Report an error
Lifeaz	France	AED CLARK 2G DE3 refs AED CLARK 2G FR93/42 AED CLARK 2G IT93/42 AED CLARK 4G DE93/42 AED CLARK 4G DE PRO93/42 9 others AED CLARK 4G DK93/42 AED CLARK 4G ES PRO93/42 AED CLARK 4G FR93/42 AED CLARK 4G FR PRO93/42 AED CLARK 4G HU PRO93/42 AED CLARK 4G IT93/42 AED CLARK 4G IT PRO93/42 AED CLARK 4G PL PRO93/42 PROCEDURE PACK CLARK 2G DE3 refs	IIb, III MDR, 93/42	regulatory@lifeaz.fr EUDAMED record Report an error
Medline FDA EU representative : Medline International France (France)	United States	KIT PERCEPTOR DT W/F.D. PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 MANIFOLD 1-V COMP. RH/OFF PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 MANIFOLD 3V COMP. RH/OFF PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 MANIFOLD 3V COMP. RH/ON PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 MANIFOLD ASM 1V RH/OFF PERC. PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 9 others MANIFOLD COMP MP 2V 200S RH OFF PG, DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 MANIFOLD, PERC MP 3V 200S RH OFF PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 MANIFOLD, PERC MP 3V 200S RH ON PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 PERCEPTOR DT TRANS.24P.TAIL PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 PERCEPTOR DT TRANS.48P.TAIL PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 STD. RT/HRT KIT-PROXIMAL MOUNT PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 TRANS. PERC. DT DISP. TOP MOUNT PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 TRANS. PERC. DT DISP.BOT MOUNT PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42 TRANSDUCER PERC. DT DISP. W/SC PG DC323 - NAMIC_Disposable Blood Pressure Transducers93/42	IIa 93/42	EUDAMED record Report an error
Okuman	Türkiye	Central Monitoring System OKM 880093/42 Defibrillator Monitor DFM 60093/42 Defibrillator Monitor DFM 80093/42 Multi-parameter Patient Monitor OKM 1042 refs93/42 Multi-parameter Patient Monitor OKM 1212 refs93/42 9 others Multi-parameter Patient Monitor OKM 3002 refs93/42 Multi-parameter Patient Monitor OKM 50014 refs93/42 Multi-parameter Patient Monitor OKM 6002 refs93/42 Multi-parameter Patient Monitor OKM 7002 refs93/42 Multi-parameter Patient Monitor OKM 8003 refs93/42 Multi-parameter Patient Monitor OKM 8493/42 Multi-parameter Patient Monitor OKM 86093/42 Multi-parameter Patient Monitor OKM 9002 refs93/42 Multi-parameter Patient Monitor OKM VS32 refs93/42	IIb 93/42	Website info@okuman.com.tr EUDAMED record Report an error
Idmed FDA	France	TOFscan (branded Idmed) TOF-MU3 refs TOFscan EMG-SU TOFscan TF2-PS3 refs TOFscan TF2-Sensor2 refs TOFscan TF2-System2 refs 8 others ToFscan TOF-Cable ToFscan TOF-Sensor3 refs ToFscan TOF-Sticker ToFscan TOF-System3 refs TOFWiTOF-PS3 refs WiTOF4 refs WiTOF (branded Draeger) WiTOF-MU ToFscan TOF-SinUseSensor (no longer marketed)	I, IIa MDR	info@idmed.fr EUDAMED record Report an error
Andon Health FDA EU representative : iHealthLabs Europe SAS (France)	China	213-KD-5920(KD-5920B)3 refs 213-KD-5920(KD-5920B) Cuff3 refs 32921(KD-558)2 refs Aponorm Mobil Basis (KD-722)3 refs BBPM 4541WN(KD-738BR)3 refs 7 others HCBL400WT(KD-553)2 refs iHealth Ease (BP3L)3 refs iHealth View (BP7S) KD-7815(KD-7815) PC-PO 3104(PO6)3 refs PO6L93/42 Wrist Blood Pressure Monitor KD-738BR93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Hunan Beyond Medical Technology FDA EU representative : MedPath GmbH (Germany) and 1 other	China	Infusion Pump BYS-82093/42 Infusion Pump BYZ-820D93/42 Infusion Pump BYZ-820S93/42 Infusion Pump Sunfusion Anim-893/42 Infusion Pump Sunfusion Erch-693/42 7 others Infusion Pump Sunfusion Semi-293/42 ResFree Series Positive Airway Pressure Devices R-20C; R-20A; R-20i; F-20C;F-20A; F-20i;3 refs ResFree Series Positive Airway Pressure Devices R-25A; R-25S; R-30A; R-25T; R-25P; R-25V; R-30T; R-30P; R-30S; R-30V; R-30F; F-25A; F-25S; F-30A; F-25T; F-25P; F-25V; F-30T; F-30P; F-30S; F-30V; F-30F3 refs ResHope Series Positive Airway Pressure Devices6 refs Syringe Pump BYZ-81093/42 Syringe Pump BYZ-810D93/42 Syringe Pump BYZ-810S93/42	IIa, IIb MDR, 93/42	Website sale@csbeyond.com EUDAMED record Report an error
Northern Meditec EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Anesthesia machine Atlas N393/42 Anesthesia machine Atlas N593/42 Multi-parameter patient monitor Aquarius93/42 Multi-parameter patient monitor Aries93/42 Multi-parameter patient monitor Gemini93/42 7 others Multi-parameter patient monitor Taurus93/42 Multi-parameter patient monitor Taurus B93/42 Multi-parameter patient monitor TaurusA93/42 Multi-parameter patient monitor Venus93/42 Multi-parameter patient monitor Z12030293/42 Neonatal Ventilator Crius V5A，Crius V5B Positive airway pressure device Crius V2-20,Crius V2-25S,Crius V2-25ST,Crius V2-25PC,Crius V2-25 Pro,Crius V2-30S,Crius V2-30T,Crius V2-30ST,CriusV2-30PC,Crius V2-30 Pro2 refs	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Ambulanc (Shenzhen) Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Automatic External Defibrillator i7、i7 Plus、i9、i9 Plus、LS1 Semi Automatic、 LS1 Pro Semi Automatic、 LS1 Fully Automatic、 LS1 Pro Fully Automatic3 refs CPR System E5, E6, E7, E83 refs Emergency and Transport Ventilator T593/42 Emergency and Transport Ventilator T550, T500, T350, T3003 refs Nasal Continuous Positive Airway Pressure System 68B93/42 6 others Non-invasive Ventilator Anim25S, Anim25Vt, Anim30AV3 refs Semi-automatic external defibrillator i393/42 Semi-automatic external defibrillator i593/42 Syringe Pump SP50p, SP50n, SP10p, SP10n3 refs Transport Ventilator 6000S93/42 Ventilator T6	IIa, IIb, III MDR, 93/42	Website info@amoulmed.com EUDAMED record Report an error
Kjump FDA EU representative : Polygreen Germany GmbH (Germany)	Taiwan	Biopax KP-624193/42 Biopax KP-762093/42 KP-624193/42 KP-762093/42 KP-767293/42 6 others MEDIBIONIK93/42 MEDIBIONIK KP-624193/42 NO KP-767093/42 Polygreen KP-675093/42 SCALA KP-602793/42 SCALA KP-762093/42	IIa 93/42	Website service@polygreen.com.tw EUDAMED record Report an error
Ningbo David Medical Device FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Infant T-piece Resuscitator NEO-I/NEO-II2 refs Patient Monitor D693/42 Patient Monitor D6/D7/D8/D60/D70/D80/D6S/D7S/D8S3 refs Patient Monitor D6093/42 Patient Monitor D6S93/42 6 others Patient Monitor D793/42 Patient Monitor D7093/42 Patient Monitor D7S93/42 Patient Monitor D893/42 Patient Monitor D8093/42 Patient Monitor D8S93/42	IIb MDR, 93/42	Website EUDAMED record Report an error
Pulmodyne EU representative : QNET B.V. (Netherlands)	United States	G0-PAP 313-460393/42 Go-PAP 313-460093/42 Go-PAP 313-460193/42 Go-PAP 313-4601N93/42 Go-PAP 313-460293/42 6 others Go-PAP 313-4602N93/42 Go-PAP 313-4603N93/42 Go-PAP 313-460493/42 Go-PAP 313-4604N93/42 Go-PAP 313-460593/42 GO-PAP 313-4605N93/42	IIa 93/42	EUDAMED record Report an error
Spiegelberg FDA	Germany	ICP Monitor HDM29.293/42 Parenchymal Probe 4F ICP.3.ST3 refs Pressure Monitor MON.1.ST Probe 3 PN with Trocar SND13.1.5493/42 Probe 3PN SND13.1.53/FV534P93/42 6 others Probe 3PS SND13.1.63/FV535P93/42 Silverline® Ventricular Probe 10F SND13.1.1593/42 Silverline® Ventricular Probe 8F SND13.1.1493/42 Silverline® Ventricular Probe with Cranial Bolt 8F SND13.1.14S93/42 Sonde 3 SND13.1.13/FV532P93/42 Sonde 3XL SND13.1.13XL/FV533P93/42	IIa, III MDR, 93/42	Website info@spiegelberg.de EUDAMED record Report an error
GE Healthcare FDA	Finland	5876727 5897060 Carescape B450 MBA413 Carescape Canvas 1000 5958112 Carescape Canvas Smart Display 5962265 9 others Carescape ONE 5956031 MBA323 MBB323 Portrait HUB01 Portrait HUBXB CARESCAPE MBB31393/42 (no longer marketed) CARESCAPE MBC31393/42 (no longer marketed) CARESCAPE MBC32393/42 (no longer marketed) MBA31393/42 (no longer marketed)	IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Medlab	Germany	110 h93/42 CAP105 refs93/42 P-OX100L3 refs93/42 PEARL100L5 refs93/42 PEARL56 refs93/42 5 others PEARL83 refs93/42 VITRO 04100-DE-00-0093/42 VITRO 04100-EN-00-0093/42 VITRO 04100-PL-00-0093/42 VITROmap3 refs93/42	IIb 93/42	Website sales@medlab.eu EUDAMED record Report an error
Penlon FDA EU representative : Obelis s.a. (Belgium)	United Kingdom (ex Northern Ireland)	AV-S Anaesthesia Ventilator93/42 AV-S MRI Anaesthesia Ventilator93/42 Prima 320 Advance Anaesthetic Machine93/42 Prima 320 Anaesthetic Machine93/42 Prima 440 Anaesthetic Machine93/42 5 others Prima 445 Anaesthetic Machine93/42 Prima 450 Anaesthetic Machine93/42 Prima 451 MRI Anaesthetic Machine93/42 Prima 460 Anaesthesia Machine Prima 460 Anaesthetic Machine93/42 Prima 465 Anaesthesia Machine93/42	IIb 93/42	Website EUDAMED record Report an error
HEYER Medical EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Anaesthetic Workstation AG55、AG70、AG753 refs Anaesthetic Workstation AG7093/42 Ventilator VG50/VG50B/VG50S3 refs Ventilator VG55、VG653 refs Ventilator VS300S93/42 5 others Ventilator VS300S/VS500S/VS600S2 refs Ventilator VS500S2 refs93/42 Ventilator VS600S93/42 Ventilator VT80002 refs Anaesthetic Workstation AG7593/42 (no longer marketed)	IIb MDR, 93/42	Website EUDAMED record Report an error
Sentec FDA EU representative : Sentec GmbH (Germany)	Switzerland	Calibration Gas2 refs Contact Gel GEL-042 refs Digital Sensor Adapter Cable 150 cm3 refs Ear Clip EC-MI Isolation Transformer2 refs 5 others Membrane Changer3 refs Multi-Site Attachment Ring3 refs SDM Water Protection Cover Staysite Adhesive Patient Application Kit for mature/intact skin3 refs (no longer marketed)	I MDR	Website info@sentec.com EUDAMED record Report an error
Combei FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Acard Ticatrom BP200A，BP116A，BP800A，BP156A，BP136A3 refs Arm Blood Pressure Monitor BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C3 refs Arm Blood Pressure Monitor BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A3 refs Arm blood pressure monitor BP118A ，BP810A，BP102A，BP820A，BPCB0A-2H，BP880A3 refs BP660A 4 others CUFF(22-42cm)3 refs Infrared thermometer NC100（ORO-BABY COLOR）93/42 Wrist blood pressure monitor BP606W，BW 315，BW A45，BW A30，BP608W，BP300W3 refs Wrist blood pressure monitor BP885W，BW 320，BP880W，BPCB0A-2F2 refs	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Dixion	Germany	DIXION Aeros 4300S DIXION Aeros 4600 DIXION Aeros 4800 DIXION Instilar 1410 DIXION Instilar 1420 4 others DIXION Instilar 1428 DIXION Instilar 1450 DIXION Instilar 1550 DIXION Instilar DS	I, IIb MDR	Website info@dixion.de EUDAMED record Report an error
Health & Life EU representative : Emergo Europe B.V. (Netherlands) and 1 other	Taiwan	Automatic Upper Arm Blood Pressure Monitor BU 580 connect, HL858B1-LT93/42 Automatic Upper Arm Blood Pressure Monitor BU 582, HL858B1-L93/42 Automatic Upper Arm Blood Pressure Monitor BU 584 connect, HL858B1-LT93/42 Automatic Upper Arm Blood Pressure Monitor HL858A393/42 Automatic Upper Arm Blood Pressure Monitor HL858B1-T, BU 586 voice93/42 4 others Automatic Upper Arm Blood Pressure Monitor HL868ED93/42 Automatic Upper Arm Blood Pressure Monitor HL868ZA93/42 Automatic Upper Arm Blood Pressure Monitor Sanitec HL858A193/42 Automatic Wrist Blood Pressure Monitor HL158AU-D93/42	IIa 93/42	Website EUDAMED record Report an error
Integralife FDA EU representative : Integra LifeSciences Services (France)	United States	CereLink™ 82685093/42 CereLink™ 82685193/42 CereLink™ 82685293/42 CereLink™ 82685493/42 Codman Microsensor® 62663193/42 4 others Codman Microsensor® 62663293/42 Codman Microsensor® 62663893/42 CODMAN MICROSENSOR® 62665393/42 Codman® CereLink®93/42	IIb, III 93/42	EUDAMED record Report an error
Pooyandegan rah saadat EU representative : Trionara Technologies AB (Sweden)	Iran	SAADAT Alborz B9 SAADAT Alvand H12 SAADAT Alvand H18 SAADAT Alvand V18 SAADAT Aria 4 others SAADAT BP4 SAADAT Respina P1 SAADAT Respina P2 SAADAT Zagros S	IIa, IIb MDR	Website EUDAMED record Report an error
Pulse for Integrated Solutions	Germany	RIMPulse Android Mobile Application93/42 RIMPulse Android Watch application93/42 RIMPulse Apple Watch application93/42 RIMPulse firmware93/42 RIMPulse iOS Mobile application93/42 4 others RIMPulse Mobile ECG Device and System Model 193/42 RIMPulse Mobile ECG Device and System Model 293/42 RIMPulse PC Application93/42 RIMPulse Server Software93/42	IIa 93/42	Website info@pulsegmbh.de EUDAMED record Report an error
Suntechmed FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	222APC3 refs 222OPC3 refs 250D ABPM2003 refs DC1003 refs 4 others SELF1003 refs Stress1003 refs Tango M2 21303 refs WK1002 refs	I, IIa MDR	Website EUDAMED record Report an error
Datex-Ohmeda FDA EU representative : GE Healthcare Finland Oy (Finland) and 1 other	United States	Aisys CS293/42 Carestation 620 A1, Carestation 650 A1, Carestation 650c A13 refs Carestation 750 A1 Carestation 750 & Carestation 750c2 refs Carestation 850, Carestation 850c2 refs CS600 V1 to V2 Upgrade BG Carestation 620 A1, Carestation 650 A1, Carestation 650c A13 refs 4 others TEC 6 PLUS VAP DES 220/240V DE93/42 TEC 6 PLUS VAP DES 220/240V DE SERVICED93/42 TEC 6 PLUS VAP DES 220/240V IT93/42 Avance CS293/42 (no longer marketed)	IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Bbraun FDA	Germany	ABPM CUFF (L)3 refs Infusomat® compact plus P Space Station MRI SpaceCover Comfort3 refs Spaceplus MRI Station2 refs 3 others SpaceplusStation w/o PoleClamp3 refs Space®plus Infusomat® Space®plus Perfusor®	I, IIb MDR	Website eudamed@bbraun.com EUDAMED record Report an error
Daiwha EU representative : mdi Europa GmbH (Germany)	South Korea	DAIWHA Corp., Ltd DI-200093/42 Daiwha Corp., Ltd. DI-220093/42 Daiwha Corp., Ltd. DI-400093/42 Daiwha Corp., Ltd. DI-600093/42 Daiwha Corp., Ltd. DI-6000V93/42 3 others Daiwha Corp., Ltd. DI-6200V93/42 Daiwha Corp., Ltd. DS-300093/42 Daiwha Corp., Ltd. DS-500093/42	IIb 93/42	Website info@daiwha.com EUDAMED record Report an error
Defibtech FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Defibtech ACC Rechargeable Battery Pack Defibtech ARM XR Automated Chest Compressor3 refs Defibtech Lifeline Auto DDU-12093/42 Defibtech Lifeline ECG 2 DDU series3 refs Defibtech Lifeline ECG DDU-245093/42 Defibtech Lifeline Pro DDU series - ECG 3 others Defibtech Lifeline View Auto DDU-220093/42 Defibtech Lifeline View DDU-230093/42 Lifeline DDU-10093/42	IIb, III MDR, 93/42	service@defibtech.com EUDAMED record Report an error
Fisher & Paykel Healthcare FDA EU representative : FISHER & PAYKEL HEALTHCARE SAS (France)	New Zealand	F&P AIRVO 2 PT101EW93/42 F&P AIRVO 2 PT101UK93/42 F&P AIRVO 33 refs F&P AIRVO 3 JUNIOR PT321UK93/42 F&P AIRVO 3 NIV PT311EW93/42 3 others F&P MYAIRVO 2 PT100EW93/42 F&P NEOPUFF F&P NEOPUFF RD900AFU93/42	IIa, IIb MDR, 93/42	Customer.CareNZ@fphcare.co.nz EUDAMED record Report an error
Hingmed FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other	China	ABP-0393/42 DBP-01HP93/42 DBP-01HP, DBP-01P DBP-01P93/42 Q0693/42 3 others Q06B93/42 Q06B, Q062 refs WBP-02A4 refs	IIa MDR, 93/42	EUDAMED record Report an error
medical ECONET	Germany	M1093/42 M2093/42 Palmcare PRO93/42 Palmcare PRO (Li-Ion)93/42 Proview 103 refs 3 others PROVIEW 10 lite93/42 PROVIEW 1293/42 Proview 15	IIb MDR, 93/42	Website info@medical-econet.com EUDAMED record Report an error
Raycome FDA EU representative : Lotus NL B.V. (Netherlands)	China	Raycome BP-37A/ BP-66A/ BP-88A93/42 Raycome BP520D,BP520DB,BP550D,BP550DB,BP550D-H,BP550DB-H2 refs Raycome RBP-1100、RBP-120093/42 Raycome RBP-1100，RBP-1200 Raycome RBP-6700/ RBP-690393/42 3 others Raycome RBP-7000, RBP-7000B, RBP-7000W, RBP-9000, RBP-9000c，BP5000, BP5000B Raycome RBP-7000/RBP-7000B/RBP-7000W93/42 Raycome RBP-9000/ RBP-910093/42	IIa MDR, 93/42	EUDAMED record Report an error
Shenzhen Unicare Electronic EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Multi-parameter Patient Monitor F10 Multi-parameter Patient Monitor F15 Multi-parameter Patient Monitor F4 Multi-parameter Patient Monitor F5 Multi-parameter Patient Monitor F6 3 others Multi-parameter Patient Monitor F7 Multi-parameter Patient Monitor F8 Multi-parameter Patient Monitor F9	IIb MDR	Website 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 YM10193/42 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, YM6033 refs Pulse Oximeter YH01,YH022 refs Pulse Oximeter YM10193/42 Pulse Oximeter YM10293/42 3 others Pulse Oximeter YM10393/42 Pulse Oximeter YM20193/42 Upper Arm Electronic Blood Pressure Monitor YP7101/YP7201/YP72023 refs	IIa MDR, 93/42	EUDAMED record Report an error
SOMNOmedics FDA	Germany	ABPMpro2 refs ABPMpro Advanced3 refs Add on device SOMNOwatch plus ACTI3 refs HomeSleepTest2 refs HomeSleepTest (HST) + Tablet3 refs 3 others OtwoFellow (Size L)3 refs SOMNOwatch eco Blue3 refs SOMNOwatch™ eco3 refs	IIa MDR	Website EUDAMED record Report an error
Citizen EU representative : Emergo Europe B.V. (Netherlands)	Japan	CH452-CN CH-45293/42 CH453-CN CH-45393/42 CITIZEN CH-45693/42 CITIZEN CH-65793/42 CITIZEN CHU30693/42 5 others CITIZEN CHU50393/42 CITIZEN CHUG33093/42 CH-650-BSA93/42 (no longer marketed) CHU306-SA93/42 (no longer marketed) CHUG330-SA-LP(LPSA)93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Breas FDA	Sweden	Vivo 1 Vivo 2 Vivo 3 Vivo 45 LS/ NIPPY 4+2 refs Vivo 45/NIPPY 42 refs 4 others Vivo 55 Vivo 65 Z1 Auto-CPAP93/42 (no longer marketed) Z1 CPAP93/42 (no longer marketed)	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Arab For Industry Trading Agencies Acita EU representative : CMC Medical Devices & Drugs SL (Spain)	Egypt	Pressure transducer DPTYYMM000-A93/42 Pressure transducer DPTYYMM000-D93/42 Pressure transducer DPTYYMM000-E93/42 Pressure transducer DPTYYMM000-M93/42 Pressure transducer DPTYYMM000-P93/42 2 others Pressure transducer DPTYYMM000-U93/42 Pressure transducer DPTYYMM000-V93/42	IIa 93/42	EUDAMED record Report an error
Biçakçilar Tibbi̇ Ci̇hazlar Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Türkiye	BIÇAKCILAR93/42 BIÇAKCILAR CVP SET93/42 BIÇAKCILAR JIBPT-01-PVB PRESSURE MONITORING SET-W/1 TRANSDUCER93/42 BIÇAKCILAR PRESSURE MONITORING SET MONO2 refs93/42 BIÇAKCILAR PRESSURE MONITORING SET-W/1 TRANSDUCER6 refs93/42 2 others BIÇAKCILAR PRESSURE MONITORING SET-W/2 TRANSDUCERS7 refs93/42 BIÇAKCILAR PRESSURE MONITORING SET-W/3 TRANSDUCERS93/42	I, IIb 93/42	Website info@kocmedical.com EUDAMED record Report an error
Dima Italia FDA	Italy	BB Respirator2 refs93/42 LUNA 10093/42 LUNA 15093/42 Multilevel Night & Day ST3093/42 Multilevel Night & Day ST30V93/42 2 others Multilevel Night & Day ST4093/42 Multilevel Night & Day ST40V93/42	IIb 93/42	EUDAMED record Report an error
GE Medical Systems Information Technologies FDA EU representative : GE Medical Systems SCS (France)	United States	B105M Patient Monitor B105P3 refs B105M Patient Monitor B105P B125P B105M B125M B155M3 refs CARESCAPE F0 DOCK2 refs CARESCAPE PDM (Patient Data Module) Portrait CVA01 2 others Portrait CVAXB2 refs Portrait VSM	IIb MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Heyer Medical	Germany	LUVAR A Many3 refs Pasithec Grundgerät Antriebsgas O293/42 Pasithec II Grundgerät93/42 PORT+ Grundgerät Englisch93/42 PORT+ Grundgerät Italienisch93/42 2 others PORT+ Grundgerät mit Oxygen cylinder set Englisch93/42 PORT+ Grundgerät mit Oxygen cylinder set Italienisch93/42	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Jiangxi Aicare Medical Technology FDA EU representative : Caretechion GmbH (Germany)	China	Electronic Sphygmomanometers X193/42 Electronic Sphygmomanometers X1193/42 Electronic Sphygmomanometers X293/42 Electronic Sphygmomanometers X593/42 Electronic Sphygmomanometers X693/42 2 others Electronic Sphygmomanometers X793/42 Electronic Sphygmomanometers X893/42	IIa 93/42	Website EUDAMED record Report an error
Mipm FDA	Germany	MRI Patient Monitor Tesla DUO MRI Patient Monitoring System Tesla M3 TeslaM3 MRI Patient Monitoring System SpO2 Adapter large Sp02 Adapter3 refs SpO2 Clip Adapter SpO2 Finger Adapter M-Flex 2 others TeslaiV1 TOF3D - Neuromuscular Transmission Monitor	I, IIa, IIb MDR	Website info@mipm.com EUDAMED record Report an error
Radianqbio EU representative : S.B. Pharma GmbH (Germany)	South Korea	Heart Guardian HR-50193/42 Heart Guardian HR-70193/42 Heart Guardian HR-701 A93/42 Heart Guardian HR-701 B93/42 Heart Guardian HR-701 Plus93/42 2 others Heart Guardian HR-701 Plus A93/42 Heart Guardian HR-701 Plus B93/42	IIb 93/42	Website sales@radianqbio.com EUDAMED record Report an error
Resplabs FDA EU representative : Obelis s.a. (Belgium)	Mexico	Carbon filter cartridge and check valve2 refs CPAP Adapter – Compatible with AirMini Hose Connector3 refs CPAP Battery – Freedom 160W Battery CPAP Filters B078KTVLWL3 refs CPAP Hose3 refs 2 others CPAP Mask Wipes3 refs CPAP Tabs3 refs	I MDR	EUDAMED record Report an error
Shenzhen Enmind Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	EN-D7 Smart93/42 EN-N5 EN-N5H, EN-N5HZ EN-S7, EN-S7 Smart EN-V3, EN-Z30 2 others EN-V5, EN-Z50 Infusion Pump EN-V793/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Skanray FDA EU representative : SKANRAY EUROPE SRL (Italy)	India	Athena 5001 Athena 500i93/42 Comet Plus2 refs93/42 SkanRevive2 refs93/42 Star 657 refs93/42 Star 9016 refs93/42 2 others TruSkan S5008 refs93/42 TruSkan S60010 refs93/42	IIb 93/42	office@skanray.com EUDAMED record Report an error
Sophysa FDA	France	KIT PRESSIO® POUR MONITORING DE PRESSION ET DE TEMPÉRATURE INTRACRÂNIENNES, PARENCHYMATEUX À BOULON PSO-PBT93/42 PRESSIO® 2 ICP MONITOR93/42 PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT PSO-PTT93/42 PRESSIO® ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING PSO-VTT93/42 PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT PSO-PB93/42 2 others PRESSIO® MONITORING KIT, PARENCHYMAL TUNNELING PSO-PT93/42 PRESSIO® MONITORING KIT, VENTRICULAR TUNNELING PSO-VT93/42	IIb, III 93/42	Website contact@sophysa.fr EUDAMED record Report an error
Spengler	France	Brassard PNI 2 poches immerg. Easy Cuff® large adulte 2x(33-41cm) DDM NIBP Cuff3 refs Tensiomètre au bras Autotensio®93/42 Tensiomètre au bras Autotensio® Corail93/42 Tensiomètre au bras Tensonic®93/42 Tensiomètre au poignet Autotensio®93/42 2 others Tensiomètre au poignet Autotensio® Corail93/42 Tensiomètre au poignet Tensonic®93/42	I, IIa MDR, 93/42	qualite@spengler-med.fr 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 Pro3 refs TOPSONMED, LC-BPAP-2093/42 TOPSONMED, LC-BPAP-20A93/42 TOPSONMED, LC-BPAP-20T93/42 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 Pro3 refs 2 others TOPSONMED, LC-CPAP93/42 TOPSONMED, LC-CPAP Pro93/42	IIa MDR, 93/42	sales@topsonmed.com EUDAMED record Report an error
Fritz Stephan	Germany	EVE IN2 refs EVE NEO + Masimo rainbow SET2 refs EVE TR + Masimo rainbow SET2 refs Oxylog 6003 refs Oxylog 600 IC3 refs 1 other Stephanie 4G	IIb MDR	Website info@stephan-gmbh.com EUDAMED record Report an error
Geratherm	Germany	Geratherm® active control GT-121593/42 Geratherm® active control+ GT-111593/42 Geratherm® desktop GP-662193/42 Geratherm® easy med GT-868UF93/42 Geratherm® smart GT-177593/42 1 other Geratherm® wristwatch KP-613093/42	IIa 93/42	Website info@geratherm.com EUDAMED record Report an error
Hans Dinslage	Germany	SBC 31 SBM 153 refs SBM 182 refs SBM 223 refs SBM 41 1 other SPO 253 refs	IIa MDR	service@sanitas-online.de EUDAMED record Report an error
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	Japan, United States	BEDSIDE MONITOR BSM-57323 refs Central Monitor CNS-2101 Central Station Multi Parameter/ SpO2 Unit QI-102V2 refs Pulse Oximeter　OLV-4201 1 other Telemetry System　WEP-5204K93/42	IIa, IIb MDR, 93/42	Website information@db.nkc.co.jp EUDAMED record Report an error
Qingdao Yasee Medical Device FDA EU representative : MedPath GmbH (Germany)	China	Blood pressure monitor JN-163A93/42 Blood pressure monitor JN-163B93/42 Blood pressure monitor JN-163C93/42 Blood pressure monitor JN-163D93/42 Blood pressure monitor JN-163EW93/42 1 other MONITOR DE PRESION ARTERIAL TENSIOCARE JN-163D93/42	IIa 93/42	EUDAMED record Report an error
Sechrist Industries FDA EU representative : Obelis s.a. (Belgium)	United States	Sechrist Monoplace Hyperbaric Chamber and Gurney 3300H93/42 Sechrist Monoplace Hyperbaric Chamber and Gurney 3300HR93/42 Sechrist Monoplace Hyperbaric Chamber and Gurney 3600H93/42 Sechrist Monoplace Hyperbaric Chamber and Gurney 3600HR93/42 Sechrist Monoplace Hyperbaric Chamber and Gurney 4100H93/42 1 other Sechrist Monoplace Hyperbaric Chamber and Gurney 4100HR93/42	IIb 93/42	Website EUDAMED record Report an error
Sefam	France	EcoStar93/42 Néa Auto3 refs Néa Duo S3 refs S.Box Duo S93/42 S.Box Duo ST93/42 1 other S.Box M-1164112 refs	IIa MDR, 93/42	Website regulatoryaffairs@sefam-medical.com EUDAMED record Report an error
ShenZhen ZhengKang Technology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Oximeter JZK-301，JZK-303, JZK-305, JZK-307, ZK-868, ZK-869, ZK-872, ZK-8763 refs Upper Arm Blood Pressure Monitor JZK-B8833 refs Upper Arm Blood Pressure Monitor ZK-B86893/42 Upper Arm Blood Pressure Monitor ZK-B86993/42 Upper Arm Blood Pressure Monitor ZK-B87293/42 1 other Upper Arm Blood Pressure Monitor ZK-B87693/42	IIa MDR, 93/42	EUDAMED record Report an error
Siare	Italy	ARIA 104 ICU LINE3 refs CAP 700 FALCO 101 FALCO HOME CARE LINE2 refs MORPHEUS E MORPHEUS LINE3 refs SIARETRON 1000 IPER 1 other SIRIO BABY 200 SIRIO LINE3 refs	IIb MDR	Website EUDAMED record Report an error
TEKNA Manufacturing FDA EU representative : Obelis s.a. (Belgium)	India	Modular Rectangular Hyperbaric Chambers 2 to 12 seats Modular Rectangular 6000 1 4 0 S/L93/42 Monoplace Hyperbaric Chambers 32” to 40" Hybrid 3200/3293/42 Monoplace Hyperbaric Chambers 32” to 40" Hybrid 3200/4093/42 Multiplace Hyperbaric Chambers 60” to 96” Model 5000/72 S/L (6)93/42 Multiplace Hyperbaric Chambers 60” to 96” Model 5000/84 D/L (14)93/42 1 other Rectangular Hyperbaric Chambers 6 to 10 seats Rectangular 7000 6 S/L93/42	IIb 93/42	Website EUDAMED record Report an error
Zoll FDA EU representative : ZOLL International Holding B.V. (Netherlands)	China, United States	731 Ventilator93/42 9021020049999111093/42 AutoPulse NXT Platform R SERIES14 refs93/42 ZOLL AED PRO5 refs93/42 1 other ZOLL M251 refs93/42	IIb MDR, 93/42	Website info@zoll.com EUDAMED record Report an error
CU Medical Systems EU representative : MDSS GmbH (Germany)	South Korea	i-PAD CU-SP193/42 i-PAD CU-SP1 AUTO93/42 i-PAD CU-SP1 PLUS93/42 i-PAD CU-SPR93/42 i-PAD NFK20093/42 4 others i-PAD CU-SP293/42 (no longer marketed) i-PAD NF120093/42 (no longer marketed) i-PAD NF120193/42 (no longer marketed) LiFEGAIN CU-HD193/42 (no longer marketed)	IIb 93/42	service@cu911.com EUDAMED record Report an error
Acoresmed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Acoresmed A10193/42 Acoresmed A10293/42 Acoresmed A10493/42 Acoresmed A11293/42 Acoresmed A11493/42	IIb 93/42	Website qa@acoresmed.com EUDAMED record Report an error
Akas Medical Equipment EU representative : Amstermed B.V. (Netherlands)	India	AKAS INFUSIONS AKAS INFUMAX93/42 AKAS INFUSIONS AKAS INFUMAX 500593/42 AKAS INFUSIONS AKAS SYRU 400493/42 AKAS INFUSIONS AKAS SYRU 600693/42 AKAS INFUSIONS AKAS TERUMAX Rx93/42	IIb 93/42	Website EUDAMED record Report an error
B.Well Swiss EU representative : Blue Broccoli GmbH (Liechtenstein)	Switzerland	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-753 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.IV3 refs PRO-30 Semi-automatic blood pressure monitor2 refs PRO-39 Wrist blood pressure monitor PRO-39, PRO-29	IIa MDR	info@bwell-swiss.ch EUDAMED record Report an error
Beijing KellyMed EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Infusion pump KL-8052N3 refs KL-2031N, KL-2032N2 refs KL-5021A KL-5031N Syringe pump KL-6023 refs	IIa, IIb MDR	Website EUDAMED record Report an error
Beijing Siriusmed Medical Device EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	R5593/42 X4093/42 X4593/42 X5093/42 X5593/42	IIb 93/42	service@siriusmedica.com EUDAMED record Report an error
Beyond Air FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	LungFit PH 90002 LungFit® PH Bagging Kit 90005 LungFit® PH NDM Assembly 90014 LungFit® PH NO2 Filter 90008 LungFit® PH Verification Kit 90015	I, IIa, IIb MDR	Website EUDAMED record Report an error
Biocare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Central Monitoring System PM-200093/42 Fingertip Pulse Oximeter BP-10M93/42 Patient Monito iM 1293/42 Patient Monitor iM 1593/42 Patient Monitor PM-90093/42	IIb 93/42	regulation@biocare.com.cn EUDAMED record Report an error
Bistos FDA EU representative : Obelis s.a. (Belgium)	South Korea	BT-72093/42 BT-74093/42 BT-77093/42 BT-78093/42 Gateway BT-71093/42	IIb 93/42	Website EUDAMED record Report an error
Brosmed FDA EU representative : Brosmed Medical B.V. (Netherlands)	China	Balloon Inflation Devices93/42 Balloon Inflation Devices BM-BID-I3093/42 Balloon Inflation Devices BM-BID-I30L93/42 Balloon Inflation Devices BM-BID-II2693/42 Balloon Inflation Devices BM-BID-II3093/42	I 93/42	Website EUDAMED record Report an error
Dongguan Shengtu Industrial EU representative : Bauer + Herzog B.V. (Netherlands)	China	CPAP Headgear Neck Pad CPAP Headgear Strap Covers CPAP Hose Cover CPAP Mask Liners CPAP Nasal Mask Liners	I MDR	EUDAMED record Report an error
Edwards FDA EU representative : Edwards Lifesciences GmbH (Germany)	United States	Acumen IQ6 refs Acumen IQ Cuff3 refs Acumen IQ Fluid Meter3 refs PRESSURE TUBING 50P1063 refs TRUWAVE3 refs	IIa, IIb MDR	Website EUDAMED record Report an error
InBody FDA EU representative : InBody Europe B.V. (Netherlands)	South Korea	BP160 BP1703 refs BPBIO210 BPBIO2202 refs BPBIO250 BPBIO3203 refs BPBIO750	IIa MDR	Website EUDAMED record Report an error
Loewensteinmedical FDA	Germany	elisa 300/5002 refs elisa 600/8003 refs leon plus2 refs LEONI 4 Leoni plus HFO93/42	IIb MDR, 93/42	Website info@loewensteinmedical.com EUDAMED record Report an error
Medrena EU representative : SUNGO Europe B.V. (Netherlands)	China	Infusion Pump UniFusion VP5093/42 Infusion Pump UniFusion VP50 Pro93/42 Infusion Pump VP90 Infusion pump VP90 Neo Infusion Pump VP90 Pro	IIb MDR, 93/42	sales@medrena.com EUDAMED record Report an error
Mekics FDA EU representative : Obelis s.a. (Belgium)	South Korea	HFT70093/42 HFT751 MTV100093/42 MV200093/42 MV50	IIb MDR, 93/42	Website EUDAMED record Report an error
Nanjing Superstar Medical Equipment EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	S11002 refs S61002 refs S9030 S91303 refs S9930T	IIa, IIb MDR	EUDAMED record Report an error
Project Engineering	Italy	MostCareUp Endless93/42 MostCareUp On Demand93/42 MostCareUp On Demand / Endless2 refs Opthaem On Demand / Endless2 refs Opthaem System Endless / On Demand2 refs	IIb MDR, 93/42	Website info@proeng.it EUDAMED record Report an error
Taidoc FDA EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	Blood Pressure Monitor TD-31282 refs FORA ACTIVE plus P30 Plus93/42 FORA ACTIVE WIRELESS plus P30 Plus BT93/42 FORA Diamond CUFF BP93/42 FORA PO200 Fingertip Pulse Oximeter93/42	IIa MDR, 93/42	Website sales@taidoc.com EUDAMED record Report an error
Welch Allyn FDA EU representative : Welch Allyn Limited (Ireland)	United States	Welch Allyn Connex Integrated Wall System 901028340 refs93/42 Welch Allyn Connex ProBP 3400 digital blood pressure device 90105525 refs93/42 Welch Allyn Connex Spot Monitor 901058250 refs93/42 Welch Allyn Connex Vital Signs Monitor 901060295 refs93/42 Welch Allyn Spot Vital Signs 4400 90105714 refs93/42	IIa, IIb 93/42	Website EUDAMED record Report an error
Remote Diagnostic Technologies FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Invasive Pressure Adaptor 2 Channel- Edwards TruWave 8ft3 refs Tempus Pro Patient Monitor 00-1007-R / 86742193/42 Tempus Pro Patient Monitor 00-1024-R / 86742293/42 Tempus Pro Patient Monitor 00-1026-R / 86742393/42 2-Channel Invasive Pressure Module 01-201793/42 (no longer marketed) 2 others Tempus IC2 00-2001-R93/42 (no longer marketed) Tempus Pro Patient Monitor 00-1004-R / 86742093/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
ACUTRONIC Medical Systems EU representative : Emergo Europe B.V. (Netherlands)	Switzerland	fabian +nCPAP evolution93/42 Fabian HFO93/42 fabian HFO Light93/42 fabian Therapy evolution93/42	IIb 93/42	EUDAMED record Report an error
Beneware EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ambulatory BP ABP-01093/42 Ambulatory BP ABP-01193/42 Ambulatory BP ABP-02093/42 Ambulatory BP ABP-02193/42	IIa 93/42	Website EUDAMED record Report an error
Carlreiner	Austria	Jet-Ventilation tubing set, EvoConnect™ to EasyConnect™, single use3 refs Jet-Ventilation tubing set, EvoConnect™ to EasyConnect™, single use, sterile Jet-Ventilation Tubing Set Sterile3 refs TwinStream EVO TwinStream SHFJV93/42	IIa, IIb MDR, 93/42	Website office@carlreiner.at EUDAMED record Report an error
Ehyadarman EU representative : CERT3GLOBAL, UNIPESSOAL, LDA. (Portugal)	Iran	EDP-TS93/42 Vania93/42 Venus93/42 Venus-Neo93/42	IIb 93/42	Website qa@ehyadarman.com EUDAMED record Report an error
Erka	Germany	Erka. Erkameter 1253 refs Erka. Erkameter 125 Pro3 refs Erka. GREEN CUFF SMART3 refs Erka. Infusion/transfusion bags 500 ml Pressure infusion cuff3 refs	I, IIa MDR	Website service@erka.org EUDAMED record Report an error
Fitfaith FDA EU representative : Lotus NL B.V. (Netherlands)	China	F380 Finger Oximeter F38093/42 Finger Pulse Oximeter M130/M160/M1703 refs PULSE OXIMETER M100 M110 M120 M130 M150 M160 M17093/42	IIa MDR, 93/42	EUDAMED record Report an error
Getemed FDA	Germany	VitaGuard VG 210093/42 VitaGuard VG 31093/42 VitaGuard VG 310093/42 VitaGuard VG 5 CR3 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
Guangzhou Hypnus Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Positive Airway Pressure Device CA720W、CA720M、CA720、BA725W、BA725M、BA725、ST720、ST725W、ST725M、ST725、ST730W、ST730M、ST730、AU730W、AU730M3 refs Positive Airway Pressure Device CA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830Pro3 refs Positive Airway Pressure Device, CA720W93/42 Positive Airway Pressure Device（CA820M）93/42	IIa MDR, 93/42	EUDAMED record Report an error
Healthstats FDA EU representative : MDSS GmbH (Germany)	Singapore	BPro BT ABPM System T6200 Series BPro BT T6200 Series BPro Evo ABPM System T6200 Series BPro Evo T6200 Series	IIa MDR	Website EUDAMED record Report an error
Hunan Accurate Bio-Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	FINGERTIP OXIMETER FS20A3 refs Pulse Oximeter HS10A3 refs Pulse Oximeter WS20A SPO2 Sensors A403S-013 refs	IIa, IIb MDR	regulation@accbiomed.com EUDAMED record Report an error
KAZ Europe Sàrl FDA EU representative : Obelis s.a. (Belgium)	Switzerland	Braun ExactFit 1, BUA4000EU BUA4000 / BUA40503 refs Braun ExactFit 1, BUA50003 refs Braun ExactFit 3, BUA6150CEME Braun ExactFit 3 BUA6150 / Braun ExactFit 5 Connect, BUA63503 refs Braun ExactFit 3, BUA6150CEME, BUA6150WE Braun ExactFit 3 BUA6150 / Braun ExactFit 5 Connect, BUA635093/42	IIa MDR, 93/42	Quality_EMEA@helenoftroy.com EUDAMED record Report an error
Ksyos	Netherlands	BMI - berekening LHL-HDL - ratio ObesiQ - vragenlijst TWL - waarschuwing	I MDR	Website EUDAMED record Report an error
Mbelec FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	AED7000, AED7000Plus AED7000Plus93/42 Automatic External Defibrillator AED700093/42 DM700093/42	IIb, III MDR, 93/42	EUDAMED record Report an error
Medical Filtration Solutions EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	M01.1.04093/42 M01.1.07411 refs93/42 M01.1.0757 refs93/42 M01.1.0768 refs93/42	I 93/42	EUDAMED record Report an error
MEDIconet EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	O2ONE-H750+93/42 O2ONE-H810+93/42 OXYSYS 400093/42 OXYSYS 450093/42	IIb 93/42	Website EUDAMED record Report an error
MESI, razvoj medicinskih naprav, d.o.o	Slovenia	Automated ankle brachial pressure index measuring device ABPIMDD93/42 MESI mTABLET ABI diagnostic system MTABSYSABI93/42 MESI mTABLET BP diagnostic system MTABSYSBP93/42 MESI mTABLET SPO2 diagnostic system MTABSYSSPO293/42	IIa 93/42	Website info@mesimedical.com EUDAMED record Report an error
Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇	Türkiye	Disposable NIBP Cuff3 refs Reusable Double NIBP Hose3 refs Reusable IBP Cable and Adaptor3 refs Reusable NIBP Cuff3 refs	I MDR	Website EUDAMED record Report an error
Metrax	Germany	BJÖRN myPAD BSD3 refs HeartSave AS93/42 HeartSave Y0 Display 7" and Accs.3 refs HeartSave YA0 Display 7" and Accs.3 refs	IIb, III MDR, 93/42	vigilance@primedic.com EUDAMED record Report an error
Nouvag FDA EU representative : Nouvag GmbH (Germany)	Switzerland	Dispenser DP 3093/42 Dispenser DP 30 LipoPlus93/42 Dispenser DP 30 LipoPlus Set2 refs93/42 Dispenser DP 30 Set2 refs93/42	IIa 93/42	Website EUDAMED record Report an error
Pikdare FDA	Italy	CARDIOAfib+4 refs EasyRAPID+ LiteRAPID+ Wrist OneRAPID3 refs	IIa MDR	Website EUDAMED record Report an error
RespiraSource, OPC EU representative : Obelis s.a. (Belgium)	Philippines	CPAP Chin Strap3 refs CPAP Headgear Strap Covers3 refs CPAP Hose Coves2 refs CPAP Mask Liners3 refs	I MDR	Website info@resplabs.com EUDAMED record Report an error
SELVAS Healthcare FDA EU representative : Obelis s.a. (Belgium)	South Korea	ACCUNIQ BP21093/42 ACCUNIQ BP25093/42 ACCUNIQ BP85093/42 BP50093/42	IIa 93/42	Website info@selvashc.com EUDAMED record Report an error
Shenzhen Jamr Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	AIESI（AMBITIGLE)3 refs Alphamed Blood Pressure Monitor3 refs Controly Blood Pressure Monitor2 refs STENTIL Blood Pressure Monitor3 refs	IIa MDR	Website RA.dept@jamrmed.com EUDAMED record Report an error
Shenzhen Ruiankang Technology FDA EU representative : MedPath GmbH (Germany)	China	b-good Blood Pressure Monitor93/42 Blood Pressure Monitor RAK-FI033 refs Blood Pressure Monitor RAK28393/42 Blood Pressure Monitor RAK28893/42	IIa MDR, 93/42	RAK@szkia.cn EUDAMED record Report an error
Sol Group Lab	Italy	geaNOx2 refs geaNOx trolley2 refs iNO flextube PENELOPE MANUAL DOSING EMERGENCY KIT	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	DANA Diabecare RS93/42 DANA Diabecare RS 5 kits93/42 DANA Diabecare RS kit93/42 DANA-i93/42	IIb 93/42	Website EUDAMED record Report an error
Tuylek	Spain	Equipo multifunción KEITO93/42 Equipo Multifunción KEITO K1093/42 Equipo Multifunción KEITO K993/42 K893/42	IIa 93/42	Website info@keito.com EUDAMED record Report an error
Utastech	Slovakia	UTAS4 refs93/42 UTAS Patient monitor UM 300-10-S93/42 UTAS Patient monitor UM 300-15-S93/42 UTAS Patient monitor UM 300-20-S93/42	IIb 93/42	Website info@utastech.eu EUDAMED record Report an error
WEINMANN Emergency Medical Technology FDA	Germany	MEDUMAT Transport2 refs93/42 MEDUMAT Standard a2 refs93/42 MEDUMAT Standard²4 refs93/42 MEDUVENT Standard	IIb MDR, 93/42	Website info@weinmann-emt.de EUDAMED record Report an error
Yaklaşim Maki̇na Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	CORAL93/42 Omega93/42 SOLO93/42 TRCO293/42	IIb 93/42	Website EUDAMED record Report an error
Zerone EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	Infusion pump INFU-Z 100093/42 Infusion pump INFU-Z 200093/42 Infusion pump INFU-Z 400093/42 Syringe pump SYRIN-Z 400093/42	IIb 93/42	Website EUDAMED record Report an error
Airliquide FDA	France	Monnal T6093/42 MONNAL T60 ADVANCED3 refs MONNAL TEO5 refs MONNAL TEO NF93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Accutron FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Accutron Inc. Analog Flowmeter19 refs93/42 Accutron Inc. Digital Flowmeter23 refs93/42 Accutron Inc. Scavenging Circuit3 refs93/42	IIa, IIb 93/42	EUDAMED record Report an error
Aeonmed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Anaesthetic Workstation many3 refs Ventilator Shangrila510S4 refs93/42 Ventilator VG702 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
Ampall EU representative : AR Experts B.V. (Netherlands)	South Korea	IP-7700 Infusion pump93/42 PP-990093/42 SP-8800 Syringe Pump93/42	IIb 93/42	Website EUDAMED record Report an error
Aojmedical FDA EU representative : Share info GmbH (Germany)	China	Arm Blood Pressure Monitor ARM-30E+,AOJ-30B/A/C/D/E/F/G,ARM-30V/33C/D/E/F/G/30A+/30G1/30G2/30Q/30G+/30M/30M+/30S/30T/30J/30K/30H/30W/30C+/30U/30Y,AOJ-33A/B,ARM-HA101/HA101+,ARM-90B,XS Pro,ARM-3010/3011/3012/3013/3110/3040/3030/3060/3020/3021/3022/3023/3120,SBM 15,BU 518/BU 5203 refs PULSE OXIMETER AOJ-70A\AOJ-70B\AOJ-70C\AOJ-70D\AOJ-70E\OXI-70B\OXI-70D\OXI-70E\OXI-70F\OXI-70G\OXI-70H3 refs Wrist Blood Pressure Monitor WRS-35E\AOJ-35A\AOJ-35B\AOJ-35C\AOJ-35D\AOJ-35E\AOJ-35F\AOJ-35G\WRS-35K3 refs	IIa MDR	regulation@aojmedical.com EUDAMED record Report an error
Atlantamed EU representative : Casus Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Diomede93/42 Diomede-Neo93/42 Dion93/42	IIb 93/42	Website info@atlantamed.co.uk EUDAMED record Report an error
Beijing Eternity Electronic Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Anaesthesia machine AM852,AM834,AM8323 refs Emergency and Transport Ventilator SH200,SH2303 refs Ventilator SH300，SH3203 refs	IIb MDR	Website EUDAMED record Report an error
Beijing YAFMED EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ibis20093/42 Ibis30093/42 Ibis60093/42	IIb 93/42	EUDAMED record Report an error
Bio-Si International	Italy	MostCareUp Endless/OnDemand2 refs Opthaem Endless/OnDemand2 refs Opthaem System Endless2 refs	IIb MDR	regulatory@bio-si.it EUDAMED record Report an error
Cardia International	Denmark	BLOSTRUPMOEN® BM0207RF93/42 CardiAid® CT0207RF93/42 CardiAid® CT0207RS93/42	IIb 93/42	Website regulatory@cardiainternational.com EUDAMED record Report an error
Chirana	Slovakia	VENAR Libera93/42 VENAR Omega93/42 VENAR TS93/42	IIb 93/42	Website EUDAMED record Report an error
Clinomic	Germany	Mona Terminal3 refs MonaOS 2 MonaOS 3	I, IIa MDR	Website info@clinomic.ai EUDAMED record Report an error
Cofoe FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	MINDMED Automatic Wrist Blood Pressure Monitor KF-75C PROMED Automatic Upper Arm Blood Pressure Monitor KF-65A、KF-65B、KF-65D、KF-65K、KF-65R3 refs Pulse Oximeter OHT60, OHT80, OXH78, OXH883 refs	IIa MDR	Website EUDAMED record Report an error
EKU Elektronik	Germany	CARDINO NO therapy unit Gas Therapy Unit93/42 NO-A EKU therapy unit Gas Therapy Unit93/42 NO-A EKU therapy unit including O2-measurement Gas Therapy Unit93/42	IIb 93/42	Website info@eku-elektronik.de EUDAMED record Report an error
EMED Technologies FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	SCIg60 Infusion System93/42 SGI60 Infuser93/42 VersaPump Infuser93/42	IIa 93/42	Website customerservice@emedtc.com EUDAMED record Report an error
Fleming Medical EU representative : Fleming Medical (Ireland)	China	Medicare MD180893/42 Medicare MD180993/42 Medicare MD181093/42	IIa 93/42	quality@flemingmedical.ie EUDAMED record Report an error
Fukuda FDA EU representative : Emergo Europe B.V. (Netherlands)	Japan	Central Telemetry Receiver DS-1700L3 refs Central Telemetry Receiver LW-1000 ECG & Respiration Transmitter model LX-8100 type LX-81003 refs	IIb MDR	info@fukuda.co.jp EUDAMED record Report an error
Genial FDA EU representative : MedPath GmbH (Germany)	China	Digital Blood Pressure Monitor (Arm Type) GT-7023 refs Digital Blood Pressure Monitor （Wrist Yype）3 refs Finger Clip Pulse Oximeter GX103 refs	IIa MDR	admin@genial.cn EUDAMED record Report an error
Henry Schein FDA EU representative : Henry Schein Services GmbH (Germany)	United States	Henry Schein TF-0363 refs93/42 Henry Schein TF-03793/42 Henry Schein TF-04893/42	I, IIa 93/42	Website EUDAMED record Report an error
HuBDIC FDA EU representative : S.B. Pharma GmbH (Germany)	South Korea	Blood pressure monitors HBP-1520 Blood pressure monitors HBP-500 Blood pressure monitors HBP-700	IIa MDR	EUDAMED record Report an error
Innomed FDA	Hungary	CA-1 AED Plus Automated External Defibrillator CA-1 AED Plus Automated Defibrillator93/42 CA-1 AED Semi-automatic defibrillator93/42 Cardio-Aid 360-B biphasic defibrillator CA360B Clinical defibrillator93/42	IIb 93/42	Website EUDAMED record Report an error
Inosystems FDA	France	MONNAL INO3 refs ServiNO IN00019693/42 SoKINOX IN00027993/42	IIb MDR, 93/42	contact@inosystems.fr 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, BP101D3 refs BP204, BP205, BP220, BP309A, BP308A, BP308B, BP310A, BP310B, BP2073 refs BPW1, BPW2, BPW3, BPW5, BPW63 refs	IIa MDR	EUDAMED record Report an error
Lintemed FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Blood Pressure Monitor LT-P Series3 refs Fingertip Pulse Oximeter3 refs Multi-patameter moniter2 refs	IIa, IIb MDR	Website EUDAMED record Report an error
Maquet Critical Care FDA	Sweden	Flow-c3 refs Servo-c Ventilator System2 refs Servo-n Ventilator System3 refs	IIb MDR	EUDAMED record Report an error
Maxtec FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	MAXO2+ MEDICAL A ANALYZER MaxO2+ Series Oxygen Analyzers (MaxO2+A, MaxO2+AE, Handi+) MaxO2ME UltraMax O2 Oxygen Analyzer3 refs	I, IIa, IIb MDR	Website customerservice@salaera.com EUDAMED record Report an error
Medicap	Germany	Précise 80012 refs93/42 Précise 800293/42 Précise 800893/42	IIa 93/42	Website EUDAMED record Report an error
Memscap FDA	Norway	844-2893/42 Dome Sterile Monitoring line set sterile	IIa MDR, 93/42	Website EUDAMED record Report an error
Nanoomtech EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	Heart+ResQ NT-38193/42 Heart+ResQ NT-381.C93/42 HeartPlus NT-18093/42	IIb 93/42	Website EUDAMED record Report an error
NeuroDerm EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Israel	Wiederaufladbare Yurway® Pumpe2 refs Yurway® Control Station2 refs Yurway® HCP Control Station2 refs	IIb MDR	info@neuroderm.com EUDAMED record Report an error
Opsens FDA EU representative : MDSS GmbH (Germany)	Canada	F200093/42 F230093/42 OptoMonitor 32 refs	IIa, IIb MDR, 93/42	RegulatoryEurope@Haemonetics.com EUDAMED record Report an error
Oxyvein	Türkiye	OXYVEIN OXYDUO93/42 Oxyvein Oxymono93/42 OXYVEIN OXYMULTI12 refs93/42	IIb 93/42	Website info@oxyvein.com EUDAMED record Report an error
Progetti	Italy	Lung Ventilator93/42 Pompa a siringa93/42 Pompa di Infusione93/42	IIb 93/42	Website info@progettimedical.com EUDAMED record Report an error
Shanghai INT Medical Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pressure Transducer BD type, Philip type, Abbot type, Argon type, ACE type, Utah type, ELS type93/42 Pressure Transducer DPT01013 refs Pressure Transducer DPT210013 refs	IIb MDR, 93/42	EUDAMED record Report an error
Shenzhen IMDK Medical Technology FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Arm Blood Pressure Monitor BPM-A7VL IMDK Pulse Oximeter C101H1, C101A2, PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT3 refs Wrist Blood Pressure monitor BPM-W1VL	IIa MDR	service@imdker.com EUDAMED record Report an error
Shenzhen Jumper Medical Equipment FDA EU representative : MedPath GmbH (Germany)	China	CHDE&Microlife3 refs Electronic Blood Pressure Monitor JPD-HA1003 refs Electronic Blood Pressure Monitor JPD-HW100A3 refs	IIa MDR	EUDAMED record Report an error
Sistemi Iperbarici	Italy	Camera Iperbarica 1600 CI160093/42 Camera Iperbarica 2000 CI200093/42 Camera Iperbarica 2300 CI 230093/42	IIb 93/42	EUDAMED record Report an error
Terumo FDA EU representative : TERUMO EUROPE N.V. (Belgium)	Japan	TERUFUSION Infusion Pump Type LF32 refs93/42 TERUFUSION Infusion Pump Type LM36 refs93/42 TERUFUSION Syringe Pump Type SS37 refs93/42	IIb 93/42	Eudamed_LAA@terumo.co.jp EUDAMED record Report an error
Utech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Fingertip Pulse Oximeter iO293/42 Patient monitor VS2000、PM5000、PM6000、PM6800、UM2012、UM20173 refs Pulse Oximeter UT100、UPM50、UPM603 refs	IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Vennermedical FDA	Germany	PEGA PCA Infusionspumpe93/42 PEGA plus Infusionspumpe93/42 PEGA® Infuse93/42	IIb 93/42	Website info@vennermedical.de EUDAMED record Report an error
Vivest EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	A1 & A33 refs Automated External Defibrillator PowerBeat X393/42 P1 & P33 refs	IIb, III MDR, 93/42	EUDAMED record Report an error
Weony (Shenzhen) Technology EU representative : Prolinx GmbH (Germany)	China	Mesmed WBP10393/42 Mimea WBP11393/42 Weony WBP10193/42	IIa 93/42	Website EUDAMED record Report an error
Hpotech	Türkiye	Hpotech ATLANTIS 1 Person Omega Hyperbaric Oxygen Therapy System3 refs Hpotech TITANIC 10 Person Omega Hyperbaric Oxygen Therapy System3 refs TROJAN Hpotech 1 Person Omega Hyperbaric Oxygen Therapy System93/42 (no longer marketed)	IIb MDR, 93/42	Website EUDAMED record Report an error
Acare Technology FDA EU representative : Surpass Biomedical Europe B.V. (Netherlands)	Taiwan	Pulse Oximeter AH-MX93/42 Pulse Oximeter AH-TA93/42	IIb 93/42	info@acarecorp.com EUDAMED record Report an error
Acurio EU representative : MedNet EC-REP GmbH (Germany)	China	FINGERTIP PULSE OXIMETER AS-30193/42 PULSE OXIMETERS AS-302-L93/42	IIb 93/42	EUDAMED record Report an error
Aedmax	Poland	Defibrylator AED Primedic myPAD w walizce Zestaw Defibrylator AED Philips FRx Standard w torbie z kluczem pediatrycznym z kapsułą zewnętrzną	III MDR	Website EUDAMED record Report an error
AtCor Medical FDA EU representative : Advena Limited (Malta)	Australia	Non–Invasive Blood Pressure Monitoring Instruments Assy EM4 Module93/42 Non–Invasive Blood Pressure Monitoring Instruments Shipping Carton EM4 (System)93/42	IIa 93/42	info@atcormedical.com EUDAMED record Report an error
B L Lifesciences EU representative : Obelis s.a. (Belgium)	India	ipeX Plain, Red, Blue, Yellow93/42 Ipex,ABMG,ACTIMED,Quality Medical, Sky Medical, CMI Single, Double, Triple with/without sampling Device/sampling stopcock93/42	IIa, IIb 93/42	Website regulatory@bllifesciences.com EUDAMED record Report an error
Beaconn EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	BN-702 feeding pump BN-702,BN-702A enteral feeding pump BN-70293/42	IIa MDR, 93/42	info@beaconn.cn EUDAMED record Report an error
Bedfont FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	iCOquit Micro+ Smokerlyzer3 refs	IIa MDR	Website EUDAMED record Report an error
Beijing Rongrui-Century Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RESWELL RVC83093/42 RESWELL RVC830A93/42	IIa 93/42	Website EUDAMED record Report an error
Bioland FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Blood Pressure Monitor3 refs Blood Pressure Monitor 200693/42	IIa MDR, 93/42	EUDAMED record Report an error
BMC Medical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Auto CPAP System E-20A-H-O3 refs BPAP System5 refs	IIa MDR	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, BK20073 refs Electronic sphygmomanometer BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK60322 refs	I, IIa MDR	Website EUDAMED record Report an error
Bssmedikal	Türkiye	BSS MEDIKAL IV.180093/42 BSS MEDIKAL IV.2800 W93/42	IIb 93/42	Website info@bssmedikal.com EUDAMED record Report an error
Codan Argus EU representative : CODAN pvb Critical Care GmbH (Germany)	Switzerland	A616S2 refs A717V2 refs	IIb MDR	Website regulatory@codanargus.com EUDAMED record Report an error
Empatica FDA	Italy	EmbracePlus3 refs Empatica Care - Android Empatica Care - iOS Version3 refs	IIa MDR	Website info@empatica.com EUDAMED record Report an error
Envisen FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pulse Oximeter93/42 Pulse Oximeter HandyOxi50093/42	IIb 93/42	EUDAMED record Report an error
Famidoc FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Dr. Max Blood Pressure Monitor3 refs Wrist blood pressure monitor FDBP-W13 refs	IIa MDR	Website EUDAMED record Report an error
Finapres FDA	Netherlands	Finapres NOVA NOVA93/42	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-BP1313 refs Wrist Electronic Blood Pressure Monitor FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP2213 refs	IIa MDR	EUDAMED record Report an error
Flight Medical Innovations FDA EU representative : Obelis s.a. (Belgium)	Israel	Flight 6093/42 Flight 60T4 refs93/42	IIb 93/42	Website EUDAMED record Report an error
Foracare FDA EU representative : MedNet EC-REP GmbH (Germany)	Switzerland	FORA ACTIVE WIRELESS plus P30 Plus BT93/42 FORA Diamond Cuff BP Blood Pressure Monitoring System93/42	IIa 93/42	Website EUDAMED record Report an error
France Développement Electronique	France	SO-CONNECT D50 SO-CONNECT+3 refs	IIb MDR	Website qualite@fde.fr EUDAMED record Report an error
Fresenius Kabi FDA	Germany	Ambix nova3 refs INfusia3 refs	IIb MDR	Website EUDAMED-FK@fresenius-kabi.com EUDAMED record Report an error
GE Medical Systems FDA EU representative : GE Medical Systems SCS (France)	China	9100c NXT Carevance H1	IIb MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Guangdong Richjinn Medical Technology EU representative : Humiss Beratung GmbH (Germany)	China	RJA-00193/42 RJA-00293/42	IIa 93/42	EUDAMED record Report an error
Guangdong Xinyu Electronic Technology FDA EU representative : Share info GmbH (Germany)	China	Arm blood pressure monitor XY-B01、XY-B02、XY-B03、XY-B05、XY-B07、XY-B08、XY-B093 refs wrist blood pressure monitor XY-W01A、XY-W01B2 refs	IIa MDR	Website EUDAMED record Report an error
Guangzhou AXD Electronic EU representative : Eunitor GmbH (Germany) and 1 other	China	Digital Arm Blood Pressure Monitor AXD-8023 refs Sinocare AXD-80993/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Hartmann FDA	Germany	Veroval duo control 2259 Veroval duo control secure fit cuff for blood pressure monitor 28442 refs	I, IIa MDR	Website EUDAMED record Report an error
Hepho EU representative : R Sight B.V. (Netherlands)	China	Infusion Pump HF-71093/42 Syringe Pump HF-610/HF-62093/42	IIb 93/42	EUDAMED record Report an error
Hi̇pertek Elektroni̇k Ve Maki̇na San Ti̇c Şti̇	Türkiye	MONOPLACE93/42 MULTIPLACE93/42	IIb 93/42	Website information@hipertech.com.tr EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Fluent Fluid Management System93/42 Fluent Pro Fluid Management System	IIb MDR, 93/42	EUDAMED record Report an error
Huons Meditech EU representative : KTR Europe GmbH (Germany)	South Korea	DermaShine Balance Panace-DS-3093/42 DermaShine Pro Panace-DS-5093/42	IIb 93/42	EUDAMED record Report an error
Igel	Poland	ICARD L Patient Monitor93/42 ICARD M Patient Monitor93/42	IIb 93/42	Website EUDAMED record Report an error
La Tecnomedica	Italy	PRESSY X2 refs PRESSY X MAN	IIa MDR	Website info@latecnomedica.it EUDAMED record Report an error
LiDCO FDA EU representative : LiDCO Netherlands B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	HM 38-01 LiDCO Blood Pressure Module Assembly LiDCO CNAP Assembly HM 38-02 Assembly	IIa MDR	EUDAMED record Report an error
LifeSignals FDA EU representative : Renew Health Ltd. (Ireland)	United States	UbiqVue 1AX Wearable Biosensor UB1550 UbiqVue Multiparameter UX2550	IIb MDR	Website EUDAMED record Report an error
Metsismedikal	Türkiye	LIFE POINT93/42 LIFE POINT PLUS93/42	III 93/42	Website info@metsismedikal.com EUDAMED record Report an error
MY01 FDA EU representative : AR Experts B.V. (Netherlands)	Canada	MY01 ContinuousCompartmental PressureMonitor MY01-000193/42 MY01 Mobile Application MY01-APP	I, IIa MDR, 93/42	EUDAMED record Report an error
Nanjing Chenwei medical equipment EU representative : Kingsmead Service B.V. (Netherlands)	China	CWH-301093/42 CWM-30293/42	IIb 93/42	EUDAMED record Report an error
Nihon Kohden OrangeMed FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	United States	Nihon Kohden NKV-440 Ventilator System Nihon Kohden NKV-550 Series Ventilator System3 refs	IIb MDR	Website EUDAMED record Report an error
Nobamedi EU representative : JaviTech e.K. (Germany)	South Korea	Crystal MESO NBI-30093/42 Hycoox NBI-20093/42	IIb 93/42	Website contact@nobamedi.com EUDAMED record Report an error
Nutricia Medical Devices	Netherlands	Flocare Infinity7 refs Flocare Infinity (NE)93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Onyxcz	Czechia	Přenosný infuzní stříkačkový dávkovač PPS 900193/42 Přenosný infuzní stříkačkový dávkovač PPS 9001S93/42	IIb 93/42	Website EUDAMED record Report an error
Parsianmedical EU representative : Glomin GmbH (Germany)	Iran	Parsian Medical ABADIS711 Parsian Medical ACCUCAP911	IIb MDR	Website info@parsianmedical.com EUDAMED record Report an error
Phoenix Medical Systems EU representative : Obelis s.a. (Belgium)	India	nCPAP30093/42 Svaas93/42	IIb 93/42	Website EUDAMED record Report an error
Physio-Control FDA EU representative : Stryker European Operations Limited (Ireland)	United States	LIFEPAK CR2 Defibrillator794 refs93/42 LIFEPAK CR2 Defibrillator 9951293/42	IIb 93/42	Website EUDAMED record Report an error
Respironics Novametrix EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	United States	Capnostat 5 Mainstream CO2 Sensor3 refs Carescape CO2 - LoFlo	I, IIb MDR	eudamed@philips.com EUDAMED record Report an error
Rgb Medical Devices FDA	Spain	Vision AIR 1800-3C2 refs Vision DUO	IIb MDR	Website EUDAMED record Report an error
Schiller Healthcare India EU representative : SCHILLER MEDICAL (France)	India	DEFIGARD 40093/42 DEFIGARD 400x93/42	IIb 93/42	Website EUDAMED record Report an error
Senzime FDA	Sweden	ExSpiron Adult PadSets RMI-51110 ExSpiron Pediatric PadSets RMI-53040	I MDR	Website EUDAMED record Report an error
Shanxi Jerry Medical Instrument EU representative : Wellkang Ltd (Northern Ireland)	China	Fingertip Pulse Oximeter3 refs Multi-parameter Patient Monitor JERRY-A3 refs	IIa, IIb MDR	exportsales@sxjerrymed.com EUDAMED record Report an error
Shenzhen Aeon Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Pulse Oximeter A300, A310, A320, A330, A340, A310L, A340L3 refs Pulse Oximeter A31093/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Shenzhen JCR Medical Technology EU representative : Lotus NL B.V. (Netherlands)	China	Disposable pressure transducer JIBPT-0193/42 Disposable pressure transducer JIBPT-E-0193/42	IIb 93/42	EUDAMED record Report an error
Sorimex	Poland	adapter NIBP3 refs NIBP cuff3 refs	I MDR	Website office@sorimex.pl EUDAMED record Report an error
Spectrum Medical FDA EU representative : Spectrum Medical S.r.l. (Italy)	United Kingdom (ex Northern Ireland)	Quantum Informatics - Viper Quantum Informatics - Vision / Live Vue	I MDR	Website regulatory@spectrummedical.com EUDAMED record Report an error
SQ Innovation EU representative : AR Experts B.V. (Netherlands)	United States	SQDU002 SQRU002	IIb MDR	Website info@sqinnovation.com EUDAMED record Report an error
Sunlifescience EU representative : Wellkang Ltd (Northern Ireland)	China	MCC-E21, MCC-E22, MCC-E23, MCC-E24, MCC-E253 refs Sunlife MCC-E11, MCC-E12, MCC-E13, MCC-E14, MCC-E153 refs	IIb MDR	eudamed@sunlifescience.com EUDAMED record Report an error
Surgical International	Netherlands	Fluido® Compact Control Module 65010093/42 Fluido® Compact Warming Module 65020093/42	IIb 93/42	Website raqa.ptm@tsc-life.com EUDAMED record Report an error
Unimed FDA EU representative : Obelis s.a. (Belgium)	China	Disposable Blood Pressure Transduser15 refs93/42 Reusable Adult Finger Clip SpO2 Sensor93/42	IIb 93/42	Website info@unimed.cn EUDAMED record Report an error
Wellell FDA EU representative : Wellell Iberia S.L. (Spain)	Taiwan	iX Auto 9S-01060093/42 iX Fit 9S-01050093/42	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	KJ-106 GB101 GB111 DM330 DM331 DM35093/42 KJ-206 GD101 GD111 DM34793/42	I 93/42	EUDAMED record Report an error
Witmedica EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Medical Infusion Pump WIT-601A2 refs93/42 Medical Syring Pump WIT-301A2 refs93/42	IIb 93/42	Website sales@witmedical.com 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, BA41103 refs Everchek CN10 AS-55A, AS-55G3 refs	IIa MDR	sales1@asxd.com.cn EUDAMED record Report an error
Yiğit Sağlık Araç Ve Gereçleri Paz İth İhr Şti	Türkiye	Otomatik Resüsitatör HMEF Filtreli SIP003 Peep Valfli Otomatik Resüsitatör HMEF Filtreli SIP004	IIb MDR	Website EUDAMED record Report an error
Yuejamedical FDA EU representative : phoenix Medtech GmbH (Germany)	China	Electronic Blood Pressure Monitor YJ320,YJ321E,YJ326E3 refs Wrist Blood Pressure Monitor YJ110,YJ1112 refs	IIa MDR	EUDAMED record Report an error
Delbio EU representative : Delta Electronics (Netherlands) B.V. (Netherlands)	Taiwan	SPENGLER DB1293/42 Aposán DB1293/42 (no longer marketed) DB11093/42 (no longer marketed)	IIa 93/42	Website EUDAMED record Report an error
Cosinuss FDA	Germany	corpuls auryx MSxx, MCxx, RCxx3 refs c-med alpha Set3 refs (no longer marketed)	IIa, IIb MDR	Website EUDAMED record Report an error
ab medica	Italy	Wellet6 refs	IIa MDR	Website EUDAMED record Report an error
Abbott FDA EU representative : Abbott Medical (Belgium)	United States	Cool Point™	IIb MDR	EUDAMEDInq_EP@abbott.com EUDAMED record Report an error
AgVa Healthcare EU representative : CEpartner4U (Netherlands)	India	AgVa Pro , AgVa Pro +, AgVa Intelli ,AgVa Emergency , AgVa Home & AgVa One2 refs	IIb MDR	Website info@agvahealthtech.com EUDAMED record Report an error
Alcor Scientific FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	SENTINELplus S-3000-IU93/42	IIa 93/42	EUDAMED record Report an error
Alicn Medical Shenzhen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AILIFEE3 refs	IIa MDR	Website EUDAMED record Report an error
Antmed FDA EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	Disposable Pressure Transducer3 refs	IIb MDR	Website info@antmed.com EUDAMED record Report an error
Apex Medical FDA EU representative : SciPharm Sàrl (Luxembourg)	China	Micro sc Infusion Pump HK10193/42	IIb 93/42	Website info@apexdiabetes.com EUDAMED record Report an error
Archeon FDA	France	EOlife® A0000055	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)	Accoson	I MDR	EUDAMED record Report an error
Aselsan	Türkiye	ASELSAN Heartline AED 2003 refs	III MDR	Website EUDAMED record Report an error
Astraia	Germany	NEXUS / GEBURTSHILFE CTG-Überwachung (ARGUS)	IIb MDR	Website info@astraia.com EUDAMED record Report an error
Axium MTech EU representative : Cedic srl (Italy)	Switzerland	Compat Ella® Pump93/42	IIa 93/42	quality@axium-mtech.com EUDAMED record Report an error
Baroks	Türkiye	O2multi93/42	IIb 93/42	Website EUDAMED record Report an error
Baxter FDA EU representative : Baxter Deutschland GmbH (Germany)	Switzerland	EVO IQ6 refs	IIb MDR	Website EUDAMED record Report an error
Bayer FDA EU representative : Bayer Medical Care B.V. (Netherlands)	United States	MEDRAD® Intego PET Infusion System	IIb MDR	EUDAMED record Report an error
Bd FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	Switzerland	Alaris™5 refs93/42	IIb 93/42	Website EUDAMEDenquiries@bd.com EUDAMED record Report an error
Beijing Hanvon Health Technology FDA EU representative : MedPath GmbH (Germany)	China	Korotkoff Sound Blood Pressure Monitor28 refs	IIa MDR	EUDAMED record Report an error
Beijing Kingst Medical Device FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	CO2 Mainstream Module3 refs	IIb MDR	EUDAMED record Report an error
Beijing L&Z Medical Technology Development FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Link-07-2	IIa MDR	EUDAMED record Report an error
Beijing Target Medical Technologies EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	Target Medical MMBPTSA20，MMBPTSA30， MMBPTSB20， MMBPTSB30， MMBPTSC20， MMBPTSC303 refs	IIb MDR	EUDAMED record Report an error
Beijing Wanliandaxinke Instruments EU representative : MedPath GmbH (Germany)	China	Multi-parameter Patient Monitor HM3103 refs	IIb MDR	info@wldyq.com EUDAMED record Report an error
Biobeat Technologies FDA EU representative : Obelis s.a. (Belgium)	Israel	BB-613 Adhesive Unit BB-613 Series3 refs	IIa MDR	Website info@bio-beat.com EUDAMED record Report an error
Biodata Devices	Spain	LIFEHUB HOME2 refs	IIa MDR	Website EUDAMED record Report an error
Biomedical Instruments EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ambulatory Blood Pressure System BP60B	IIa MDR	Website EUDAMED record Report an error
Bionet FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	Brio X30, Brio X50, Brio X703 refs	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	nGEN Pump	IIa MDR	EUDAMED_Enquiries@its.jnj.com EUDAMED record Report an error
Biosphere Medical FDA	France	BIG60ALPHA™93/42	I 93/42	Website udiadmin@merit.com EUDAMED record Report an error
Boen Healthcare FDA EU representative : Everbiz GmbH (Austria)	China	Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff	I MDR	Website EUDAMED record Report an error
BORSAM Biomedical Instruments EU representative : Kingsmead Service B.V. (Netherlands)	China	Ambulatory Blood Pressure Measurement System ECHO93/42	IIa 93/42	Website EUDAMED record Report an error
Bracco FDA EU representative : ACIST Europe BV (Netherlands)	United States	CardioGen-82 Infusion System, Model 170193/42	IIb 93/42	Services.ProfessionalEurope@bracco.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-205B3 refs	IIa MDR	service@brav.com.cn EUDAMED record Report an error
Bursetmedikal	Türkiye	BURSET BEYAZ93/42	IIa 93/42	Website info@burset.com.tr EUDAMED record Report an error
Caesarea Medical Electronics EU representative : Becton Dickinson Ireland Limited (Ireland)	Israel	BD BodyGuard™41 refs93/42	IIb 93/42	EUDAMEDenquiries@bd.com EUDAMED record Report an error
Cardinalhealth FDA EU representative : Cardinal Health Ireland Manufacturing Limited (Ireland)	United States	KANGAROO OMNI Enteral Feeding Pumps-2a	IIa MDR	Website EUDAMED record Report an error
Cemho FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Automatic Blood Pressure Monitor CH-S691L,CH-B607,CH-B606,CH-S692L,CH-S602,CH-W701L,CH-S693L,CH-B601L,CP-B01,CH-S6033 refs	IIa MDR	EUDAMED record Report an error
Centurion Medical Products F K A Centurion Medical Products EU representative : Medline International France (France)	United States	CENTURION, COMPASS LUMBER PUNCTURE3 refs	IIa MDR	Website EUDAMED record Report an error
CLB	Netherlands	v2.293/42	IIb 93/42	Website info@clb.nl EUDAMED record Report an error
Cnsystems FDA	Austria	CNAP Monitor 500 HD93/42	IIb 93/42	Website office@cnsystems.com EUDAMED record Report an error
Coala Solutions	Sweden	Coala Heart Monitor Coala Monitor Device M2	IIa MDR	Website info@coalasolutions.com EUDAMED record Report an error
Compremium FDA EU representative : MedNet EC-REP GmbH (Germany)	Switzerland	CP Probe	IIa MDR	Website info@compremium.ch EUDAMED record Report an error
Cosmed FDA	Italy	Q-NRG series3 refs	IIa MDR	regulatory@cosmed.com EUDAMED record Report an error
Current Health FDA EU representative : CS Life Sciences Europe Ltd (Ireland)	United Kingdom (ex Northern Ireland)	Current Health Base Kit Current Health Wearable Monitoring System G293/42	IIa 93/42	Website EUDAMED record Report an error
Daeyomedi EU representative : Obelis s.a. (Belgium)	South Korea	DAEYOMEDI DMP-Lifeplus93/42	IIa 93/42	Website EUDAMED record Report an error
Demax FDA EU representative : Obelis s.a. (Belgium)	China	DPT10303 refs	IIa MDR	EUDAMED record Report an error
Diagnosis	Poland	MANKIET ROZMIAR UNIWERSALNY M/L (22-42 CM) BP-200U	I MDR	Website EUDAMED record Report an error
DM Systems (Beijing) EU representative : ADVANCED MEDICAL SYSTEMS SL (Spain)	China	Ambulatory Blood Pressure Monitors DMS300-ABP93/42	IIa 93/42	EUDAMED record Report an error
Dornier FDA	Germany	Dornier UIMS3 refs	IIb MDR	Website eudamed@dornier.com EUDAMED record Report an error
Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş	Türkiye	Otomatik Dijital Tansiyon Aleti Manşonu/Automatic Digital Blood Pressure Monitor Cuff AXD-909	I MDR	Website info@ecemedikal.com.tr EUDAMED record Report an error
Eitan Medical FDA EU representative : MedNet EC-REP IIb GmbH (Germany)	Israel	Avoset Infusion Pump AVOSET; SAPPHIRE3 refs	IIb MDR	support@eitanmedical.com EUDAMED record Report an error
Emsaş A.Ş	Türkiye	EMSAŞ3 refs	I MDR	Website EUDAMED record Report an error
EOVE	France	AC-150 Ventilator EO-150 VENTILATOR3 refs	IIb MDR	contact@eove.fr EUDAMED record Report an error
Eurosets FDA	Italy	LANDING93/42	IIb 93/42	Website EUDAMED record Report an error
Everaid FDA EU representative : Ferrer Internacional, S.A. (Spain)	South Korea	i-jet®2 refs93/42	IIb 93/42	EUDAMED record Report an error
Folee EU representative : MedPath GmbH (Germany)	China	Arm Blood Pressure Monitor DX-B113 refs	IIa MDR	EUDAMED record Report an error
Foshan Hongfeng FDA EU representative : MedNet EC-REP GmbH (Germany)	China	FOFO HFA183 refs	I MDR	Website EUDAMED record Report an error
GBUK Group FDA EU representative : Qualrep Services B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	BC-R-01-B13 refs	I MDR	Website customerservices@gbukgroup.com EUDAMED record Report an error
General Meditech FDA EU representative : Lotus NL B.V. (Netherlands)	China	Genareal G3D93/42	IIb 93/42	Website EUDAMED record Report an error
Ginevri	Italy	GIULIA93/42	IIb 93/42	Website mail@ginevri.com EUDAMED record Report an error
Globalcare FDA EU representative : Donawa Lifescience Consulting Srl (Italy)	China	Digital Blood Pressure Monitor Prolife PC2 Basic3 refs	IIa MDR	info@globalcare.com.hk EUDAMED record Report an error
Goodlymed FDA EU representative : Kingsmead Service B.V. (Netherlands)	China	A02-SE4、A02-SEB、A02-BE、A02-SE、A02-E、A01-SLB、A01-BS、A01-BL、A01-SL、A013 refs	IIa MDR	EUDAMED record Report an error
Hadleighhealth FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Pumani 3-59793/42	IIb 93/42	Website EUDAMED record Report an error
Haier EU representative : Share info GmbH (Germany)	China	Haier HYY-M501W, HYY-M502W, HYY-M504W, HYY-M505W, HYY-M701W3 refs	IIa MDR	EUDAMED record Report an error
Haiyan Kangyuan Medical Instrument FDA EU representative : Eunitor GmbH (Germany)	China	Anesthesia Masks for Single Use	IIa MDR	EUDAMED record Report an error
Hamilton Medical FDA EU representative : medin Medical Innovations GmbH (Germany)	Switzerland	ProxyCo CO2 sensor set2 refs	IIb MDR	Website regulatory.med.global@hamilton-medical.com EUDAMED record Report an error
Hangzhou Universal Electronic FDA EU representative : Share info GmbH (Germany)	China	universal GF-BP1013 refs	IIa MDR	EUDAMED record Report an error
HeartHero EU representative : Emergo Europe B.V. (Netherlands)	United States	Elliot HH052793/42	IIb 93/42	Website info@hearthero.com EUDAMED record Report an error
Henan Tuoren Medical Device FDA EU representative : MedNet EC-REP C III GmbH (Germany)	China	Single channel, double channel, triple channel3 refs	IIb MDR	info@bjtuoren.com EUDAMED record Report an error
Heyer Care EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	20C, 20A, 20A Plus, 20A Pro, B20A, B25A, BV20ST, BV25ST, BV25ST Pro, BV30ST Pro3 refs	IIa MDR	EUDAMED record Report an error
Hiprove EU representative : Caretechion GmbH (Germany)	China	Infant Oxygen Hood YZ-1303 refs	I MDR	Website EUDAMED record Report an error
Hmc Premedical FDA	Italy	VENTURI GENERATOR FOR CPAP3 refs	IIa MDR	Website info@hmcgroup.it EUDAMED record Report an error
Honeywell FDA	Germany	OxiPen (ohne Sensor)	IIb MDR	Website EUDAMED record Report an error
Honsun (Nantong) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Blood Pressure Monitor LD-5183 refs	IIa MDR	EUDAMED record Report an error
Hospital Equipment Mfg FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	India	70-522	I MDR	Website info@hemcmedical.com EUDAMED record Report an error
Hualve EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HAXE MB-300A, MB-300B, MB-300C, MB-300D, MB-300I, MW-300A, MW-300C2 refs	IIa MDR	EUDAMED record Report an error
Huawei EU representative : Lotus NL B.V. (Netherlands)	China	HUAWEI WATCH D MLY-B10、MLY-B112 refs	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, etc3 refs	I MDR	EUDAMED record Report an error
Hyb	Slovenia	IBPM Plus system HMS 1 AU2, TT93/42	IIb 93/42	EUDAMED record Report an error
Hytech-Pommec	Netherlands	HYOT 2700-20-2RD	IIb MDR	EUDAMED record Report an error
Ibex EU representative : Javitech Consulting GmbH (Germany)	South Korea	IBEX M293/42	IIb 93/42	Website EUDAMED record Report an error
IEM FDA	Germany	Tel-O-Graph GSM Plus2 refs	IIa MDR	regulatory@iem.de EUDAMED record Report an error
Inovytec FDA EU representative : Obelis s.a. (Belgium)	Israel	Ventway3 refs	IIb MDR	Website info@inovytec.com EUDAMED record Report an error
Inreda Diabetic	Netherlands	Inspirio®3 refs	IIb MDR	Website eudamedinfo@inredadiabetic.nl EUDAMED record Report an error
Jiangxi Securmed Medical Technology EU representative : phoenix Medtech GmbH (Germany)	China	Securmed3 refs	IIb MDR	EUDAMED record Report an error
Jolife FDA	Sweden	LUCAS 3 Chest Compression System 08858250000696SQ3 refs	IIb MDR	Website info@lucas-cpr.com EUDAMED record Report an error
Jousing EU representative : Wellkang Ltd (Northern Ireland)	China	iAED-S1	III MDR	EUDAMED record Report an error
Kare Medikal Ve Analitik Cih San Ve Tic Sti	Türkiye	KMV501093/42	IIb 93/42	Website EUDAMED record Report an error
LD Technology FDA EU representative : Neomedica Iberia (Spain)	United States	LD Technology C001	IIa MDR	Website EUDAMED record Report an error
Linacolmedikal	Türkiye	KIBO93/42	IIa 93/42	Website info@linacolmedikal.com EUDAMED record Report an error
Linktop EU representative : Share info GmbH (Germany)	China	Health Monitor HC-038 refs93/42	IIa 93/42	EUDAMED record Report an error
Linova-X Tech EU representative : Lotus NL B.V. (Netherlands)	China	Linova-X Digital Arm blood pressure monitor3 refs	IIa MDR	EUDAMED record Report an error
M Dialysis FDA	Sweden	Microdialysis Pump P0000032 refs	IIa MDR	Website info@mdialysis.com EUDAMED record Report an error
Mdd FDA EU representative : CS Life Sciences Europe Ltd (Ireland)	United Kingdom (ex Northern Ireland)	CO Check + CO203 refs	I MDR	Website customercare@mdd.org.uk EUDAMED record Report an error
Medexa	Sweden	Milou93/42	I 93/42	Website info@medexa.se EUDAMED record Report an error
Medke FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	NIBP CUFF C8711	I MDR	EUDAMED record Report an error
Medset	Germany	Scanlight III93/42	IIa 93/42	Website EUDAMED record Report an error
Medsure Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ambulatory Infusion Pump 3000F	IIb MDR	EUDAMED record Report an error
Medtron	Germany	Syriflow MR	IIb MDR	Website info@medtron.com EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	DiamondTemp™	IIa MDR	EUDAMED record Report an error
Medtrust	Austria	Wellion WAVE Blood Pressure Monitor93/42	IIa 93/42	Website EUDAMED record Report an error
MEDWIN France FDA	France	Backpack for enteral feeding pump Easymoov63 refs	IIa MDR	contactmedwin@vygon.com EUDAMED record Report an error
Memmert	Germany	INmplus/IFmplus3 refs	I MDR	Website info@memmert.com EUDAMED record Report an error
Mercurymed FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	MiniStatCO2 10-553703 refs	I MDR	EUDAMED record Report an error
Metran EU representative : CMC Medical Devices & Drugs SL (Spain)	Japan	Humming Vue	IIb MDR	Website support_en@metran.co.jp EUDAMED record Report an error
Micomme EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Non-invasive Ventilator ST-30H, ST-30K, ST-30C	IIa MDR	Website service@micommed.com EUDAMED record Report an error
Micrelmed	Greece	Evolution (blue)93/42	IIb 93/42	Website info@micrelmed.com EUDAMED record Report an error
Micro-Tech (Nanjing) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Balloon Inflation Device BID-15-60-01	I MDR	Website info@mtmed.com EUDAMED record Report an error
Millturn	Sweden	Juno Mk6	IIb MDR	Website order@millturn.se EUDAMED record Report an error
MIR - Medical International Research FDA	Italy	Spirodoc MIR040	IIa MDR	Website EUDAMED record Report an error
Monitortechnik FDA	Germany	Braintrend aEEG	IIb MDR	info@monitortechnik.de EUDAMED record Report an error
Monivent	Sweden	Monivent Neo100 System93/42	IIa 93/42	Website info@monivent.se EUDAMED record Report an error
MS Westfalia	Germany	Jenny Defibrillator Module paddle version3 refs	IIb MDR	EUDAMED record Report an error
Nanjing Kangju Medical Instrument EU representative : Sungo Cert GmbH (Germany)	China	Blood pressure cuff	I MDR	EUDAMED record Report an error
Neteera FDA EU representative : MedNet EC-REP GmbH (Germany)	Israel	Neteera 130H-Plus	IIa MDR	Website info@neteera.com EUDAMED record Report an error
Neurosynaptic EU representative : Amstermed B.V. (Netherlands)	India	ReMeDi NSCPL/RNK (NSCPL/RN/A, NSCPL/RN/B, NSCPL/RN/C, NSCPL/RN/D)93/42	IIa 93/42	Website info@neurosynaptic.com EUDAMED record Report an error
Newmanbrain	Spain	THEIA	IIa MDR	Website contact@newmanbrain.com EUDAMED record Report an error
Nihon Seimitsu Sokki FDA EU representative : MDSS GmbH (Germany)	Japan	DS-10 Non-Invasive Digital Blood Pressure Monitor3 refs	IIa MDR	Website info@nissei-kk.co.jp EUDAMED record Report an error
Ningbo Ranor Medical Science & Technology FDA EU representative : MedPath GmbH (Germany)	China	Arm blood pressure monitor RN-032A3 refs	IIa MDR	ranor1@chinaranor.com EUDAMED record Report an error
Novo Klinik-Service	Germany	Transducer-Fix AP Fixierung für invasive Blutdruckmesssysteme3 refs	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)	NOxBOXi93/42	IIb 93/42	EUDAMED record Report an error
OBS Medical FDA EU representative : AF Pharma Service Europe SL (Spain)	United Kingdom (ex Northern Ireland)	Visensia v4.2.3.71 011-070093/42	IIa 93/42	EUDAMED record Report an error
Ortivus	Sweden	MobiMed	IIb MDR	info@ortivus.com EUDAMED record Report an error
Oryamedikal	Türkiye	ORYANOX3 refs	IIb MDR	Website info@oryamedikal.com.tr EUDAMED record Report an error
Osatu Sociedad Cooperativa	Spain	REANIBEX-300 AED CZECH Reanibex 300 / Reanibex 5003 refs	III MDR	Website EUDAMED record Report an error
Otwo FDA EU representative : MedNet EC-REP IIb GmbH (Germany)	Canada	O-Two e700 Electronic Automatic Transport Ventilator 01EVE70093/42	IIb 93/42	Website regulatory@otwo.com EUDAMED record Report an error
Oxavita FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Argentina	Revitalair 430 by Biobarica93/42	IIb 93/42	Website EUDAMED record Report an error
Oxybarica	Spain	Cámara Hiperbárica Oxylife3 refs	IIb MDR	Website info@oxybarica.com EUDAMED record Report an error
OxyPrem EU representative : EUSwissMed GmbH (Germany)	Switzerland	NOAH Sensor Small2 refs	IIa MDR	Website info@oxyprem.com EUDAMED record Report an error
PAR Medizintechnik FDA	Germany	PHYSIO-PORT3 refs	IIa MDR	Website info@par-berlin.com EUDAMED record Report an error
Parsys	France	Station S3	IIa MDR	Website info@parsys.com EUDAMED record Report an error
Poly Medicure FDA EU representative : Obelis s.a. (Belgium)	India	CVP Manometers2 refs	IIa MDR	Website ramdas@polymedicure.com EUDAMED record Report an error
Primedic(Jiangsu) Medical Technology EU representative : Metrax GmbH (Germany)	China	DefiMonitor XD51 Pro,DefiMonitor XD75Plus,DefiMonitor XD75Pro,DefiMonitor XD700,DefiMonitor XD70,DefiMonitor XD7000,DefiMonitor XD76Lite,DefiMonitor XD61 Pro,DefiMonitor XD7Pro，DefiMonitor XD700Pro，DefiMonitor XD7000Pro,DefiMonitor XD70Pro	III MDR	EUDAMED record Report an error
Prunusmedical FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Padus 6, Padus 7, Padus 8, Padus 5, Padus 5 Pro, Padus 5m, PN50, PN55, PN60, PN65	IIb MDR	Website EUDAMED record Report an error
Qinhuangdao Kapunuomaite Medical Equipment S&T FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	CMZ10、CMZ20、CMZ30、CMZ40、CMZ50、CMY10、CMY20、CMY30、CMY40、CMY50、MEMO-Pro3 refs	IIb MDR	Website info@capnomed.cn EUDAMED record Report an error
Radiometer FDA	Denmark	TCM5 Basic TCM5 Monitor	IIb MDR	Website radiometerra_eu@radiometer.dk EUDAMED record Report an error
Raumedic FDA	Germany	OMNIBAR E5F	IIa MDR	Website contact@raumedic.com EUDAMED record Report an error
Research Production Monitor EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	PATIENT MONITOR MITAR 01 RD93/42	IIb 93/42	Website EUDAMED record Report an error
Respomed EU representative : Ruiyi Healthcare GmbH (Germany)	China	Inhaled Nitric Oxide System eNO-100, eNO-200, eNO-100Neo, eNO-200Neo, eNO-10, eNO-203 refs	IIb MDR	Website EUDAMED record Report an error
Romsons FDA EU representative : Obelis s.a. (Belgium)	India	Romsons CVP MANOMETER	IIa MDR	Website qa.ri@romsons.com EUDAMED record Report an error
Rrr Manufacturing Pty EU representative : mdi Europa GmbH (Germany)	Australia	CellAED 2.293/42	IIb 93/42	Website EUDAMED record Report an error
Salter Labs FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube Blood Pressure Cuffs3 refs	I MDR	Website EUDAMED record Report an error
Sasan	Türkiye	SASAN SB00010SN93/42	IIa 93/42	Website EUDAMED record Report an error
Sensocure	Norway	IscAlert Display Unit	IIa MDR	Website info@sensocure.no EUDAMED record Report an error
Sentechfrance	France	SENTRY MD98000120 SENTRY 1200 ST	I MDR	Website EUDAMED record Report an error
Shenyang RMS Medical Tech EU representative : MedPath GmbH (Germany)	China	Sleep Apnoea Breathing Therapy Systems APAP203 refs	IIa MDR	EUDAMED record Report an error
Shenzhen Bestman Instrument FDA EU representative : Lotus NL B.V. (Netherlands)	China	Fetal/Maternal Monitor (BFM-700M) BFM-700/BFM-700+/BFM-700A/BFM-700M/BFM-700E/BFM-700E+	IIa MDR	EUDAMED record Report an error
ShenZhen Bi-rich Medical Devices FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Pulox BR-25ST2 refs	IIa MDR	EUDAMED record Report an error
Shenzhen Caremed Medical Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	SZcaremed	I MDR	EUDAMED record Report an error
Shenzhen Changke Connect Electronics FDA EU representative : Wellkang Ltd (Northern Ireland)	China	NIBP Cuff GCF1200(989803177481)3 refs	I MDR	Website EUDAMED record Report an error
Shenzhen Hopfat Medical Instrument EU representative : Wellkang Ltd (Northern Ireland)	China	HF-B11, HF-B21, HF-B31, HF-B51, HF-B61, HF-B813 refs	IIa MDR	EUDAMED record Report an error
Shenzhen Le Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Patient Monitor PM12B/PM12D2 refs	IIb 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, etc3 refs	I MDR	EUDAMED record Report an error
Shenzhen Narig Bio-Medical Technology FDA EU representative : MedPath GmbH (Germany)	China	Kruidvat Pulse Oximeter FRO-200,FRO-201,FRO-202,FRO-203, FRO-204, FRO-100, FRO-101, FRO-102,FRO-103, FRO-1043 refs	IIa MDR	Website EUDAMED record Report an error
Shenzhen Pango Medical Electronics FDA EU representative : Lotus NL B.V. (Netherlands)	China	Automatyczny cisnieniomierz stacjonarny PG-800A series，PG-800Bseries	IIa MDR	EUDAMED record Report an error
Sleepinnov	France	Haloa93/42	IIa 93/42	Website contact@sleepinnov.com EUDAMED record Report an error
Smarthen	Spain	Moove Enteral Feeding Pump	IIa MDR	Website info@smarthen.com EUDAMED record Report an error
smartQare	Netherlands	viQtor3 refs	IIa MDR	Website EUDAMED record Report an error
Smisson-Cartledge Biomedical FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	ThermaCor® 1200 Rapid Thermal Infusion System and Accessories4 refs	IIa, IIb MDR	EUDAMED record Report an error
Spencer FDA	Italy	ENERGY BORSA TERMOREGOLATA PER RISCALD. INFUSIONI Infusion Bag	IIa MDR	Website EUDAMED record Report an error
Sunny Medical Device (Shenzhen) EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Sunmed™ disposable invasive blood pressure transducer	IIb MDR	EUDAMED record Report an error
Suzhou Engin Bio-medical Electronics EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Tissue saturation oximeters ECO-N17-C25L、ECO-N17-C22L、ECO-N17-C21L、 ECO-N17-D25L、ECO-N17-D22L、ECO-N17-D21L、 ECO-N17-E15L、ECO-N17-E12L、ECO-N17-E11L3 refs	IIa MDR	EUDAMED record Report an error
Suzhou Melodicare Medical Technology FDA EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany)	China	Mintti Vision93/42	IIa 93/42	EUDAMED record Report an error
Sxt - Sistemi Per Telemedicina	Italy	Blunotte 2 MCPA3 refs	IIa MDR	Website info@sxt-telemed.it EUDAMED record Report an error
Syncrophi	Ireland	KEWS30093/42	IIb 93/42	Website Contactus@syncrophi.com EUDAMED record Report an error
Synektik	Poland	SynDose MD	I MDR	Website EUDAMED record Report an error
Tecme FDA EU representative : Emergo Europe B.V. (Netherlands)	Argentina	NEUMOVENT3 refs93/42	IIb 93/42	Website EUDAMED record Report an error
Tema Sinergie	Italy	RAD-INJECT γ RADIOPHARMACEUTICAL PORTABLE INFUSER2 refs93/42	IIb 93/42	Website EUDAMED record Report an error
Temel	Spain	eD-AS Anaesthesia System	IIb MDR	Website EUDAMED record Report an error
TF Health FDA EU representative : Casus Europe B.V. (Netherlands)	United States	Breezing Med B20183 refs	I MDR	info@breezing.co EUDAMED record Report an error
Thornhill Research FDA EU representative : Freyr Regulatory GmbH (Germany)	Canada	Thornhill Research Inc.2 refs93/42	IIb 93/42	Website info@thornhillmedical.com EUDAMED record Report an error
Uscom FDA EU representative : Emergo Europe B.V. (Netherlands)	Australia	BPPLUS-R793/42	IIa 93/42	Website info@uscom.com.au EUDAMED record Report an error
Utahmed FDA EU representative : Utah Medical Products Ltd (Ireland)	United States	Delta-Flow3 refs	IIa MDR	Website EUDAMED record Report an error
Uzumcu	Türkiye	Nurse Call Systems 4130.xx	I MDR	Website EUDAMED record Report an error
Virtus Technology Aps FDA	Denmark	ECMO Gas Sampling Kit VT-11403 refs	I MDR	info@virtusmonitor.com EUDAMED record Report an error
Vitalsigns FDA	Sweden	CPRAIDR	I MDR	Website info@vitalsigns.se EUDAMED record Report an error
Vivardis	France	Nivolis	IIa MDR	Website EUDAMED record Report an error
Vortran FDA EU representative : Europecert UG (haftungsbeschränkt) (Germany)	United States	GO2VENT(6123)	IIb MDR	Website info@vortran.com EUDAMED record Report an error
WILAmed FDA	Germany	WILAflow Elite	IIb MDR	Website info@wilamed.com EUDAMED record Report an error
Withings FDA	France	Withings BPM Connect2 refs	IIa MDR	Website regulatory@withings.com EUDAMED record Report an error
Wooyoungmed FDA EU representative : Obelis s.a. (Belgium)	South Korea	Accumate 120093/42	IIb 93/42	EUDAMED record Report an error
Xiaoniu Health EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Auto CPAP Device AS100A,AS100C,BF20A,BF25A,BF25ST,BF30ST3 refs	IIa MDR	EUDAMED record Report an error
Yahorng FDA EU representative : Kahl Handelsvertretung (Germany)	Taiwan	GARMIN BP707	IIa MDR	Website EUDAMED record Report an error
Zarys	Poland	Zestaw wyrobów medycznych 39 ZWM-039	IIa MDR	Website EUDAMED record Report an error
Zdeer Industrial (Hubei) EU representative : JOYSUN GROUP S.L.U (Spain)	China	zdeer BL50，BL60，BL70，BL80	IIa MDR	EUDAMED record Report an error
Zevex FDA EU representative : Abbott Ireland (Ireland)	United States	FreeGo Enteral Feeding Pump3 refs	IIa MDR	EUDAMED record Report an error
Zhongshan Jinli Electronic Weighing Equipment FDA EU representative : Wellkang Ltd (Northern Ireland)	China	Electronic Blood Pressure Monitor AP8010, AP8020, AP80303 refs	IIa MDR	EUDAMED record Report an error
Alliedmed FDA EU representative : AR Experts B.V. (Netherlands) No model still on the market	India	Allied Meditec 140093/42 (no longer marketed) Allied Meditec 170093/42 (no longer marketed) ALLIED MEDITEC INFUSION WORKSTATION IC20 Infusion Workstation - Allied Meditec IC2093/42 (no longer marketed) ALLIED MEDITEC IP20093/42 (no longer marketed) ALLIED MEDITEC M30193/42 (no longer marketed) 16 others ALLIED MEDITEC M30293/42 (no longer marketed) ALLIED MEDITEC M30393/42 (no longer marketed) ALLIED MEDITEC M700 CMS ALLIED MEDITEC M700CMS93/42 (no longer marketed) ALLIED MEDITEC M70793/42 (no longer marketed) ALLIED MEDITEC M71193/42 (no longer marketed) ALLIED MEDITEC M72293/42 (no longer marketed) ALLIED MEDITEC M74293/42 (no longer marketed) ALLIED MEDITEC M74793/42 (no longer marketed) ALLIED MEDITEC M75193/42 (no longer marketed) ALLIED MEDITEC M75293/42 (no longer marketed) ALLIED MEDITEC M75793/42 (no longer marketed) ALLIED MEDITEC M77193/42 (no longer marketed) ALLIED MEDITEC M77793/42 (no longer marketed) ALLIED MEDITEC M79793/42 (no longer marketed) ALLIED MEDITEC SP20093/42 (no longer marketed) Allied Meditec Vista93/42 (no longer marketed)	IIb 93/42	Website sales@alliedmed.co.in EUDAMED record Report an error
Origin Medical Devices FDA EU representative : Donawa Lifescience Consulting Srl (Italy) No model still on the market	United States	Panther 3 Ventilator93/42 (no longer marketed) Panther 3V ventilator93/42 (no longer marketed) Panther 5 Ventilator93/42 (no longer marketed) Panther 5N Ventilator93/42 (no longer marketed)	IIb 93/42	Website EUDAMED record Report an error
Innokas Yhtymä FDA No model still on the market	Finland	CARESCAPE VC150 Vital Signs Monitor93/42 (no longer marketed)	IIb 93/42	Website prrc@innokasmedical.fi EUDAMED record Report an error
Intersurgical FDA No model still on the market	Italy	Interflow Voxy2 refs (no longer marketed)	IIb MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 2,072

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
APK Technology Co.,Ltd. Present in Europe in other categories	China	APK Nihon Kohden Nihon Kohden Disposable GE-Nellcor HP Kontron	K172981 (2018)
American Diagnostic Corp. Present in Europe in other categories	United States	Diagnostix™ AdviewII™ Adview II Adimals® Advantage™ E-Sphyg™ 3	K962655 (1997)
ICU MEDICAL, INC. Present in Europe in other categories	United States	Medex Portex Pneupac BCI ICU Medical Transpac	K262532 (2026)
Orantech Inc. Present in Europe in other categories	China	ETCO2 Sensor Orantech	K171828 (2018)
LifeSync Corporation	United States	AMC LifeSync Rochester	K071751 (2007)
CURBELL MEDICAL PRODUCTS, INC.	United States	DISP NLCR COMPAT SPO2 SNSR,NON OXMX,N25 DISP NLCR COMPAT SPO2 SNSR,OXMX,MAXN DISP NLCR COMPAT SPO2 SNSR, OXMX,SC-A REUS,PHILIPS SPO2 SNSR,9.5',LG CLAM DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-N DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-A	K182220 (2018)
RASHMAN CORPORATION	United States	Pulse Oximeter Blood Pressure Monitor Aneroids (82 etc.) Aneroid Kits Aneroid (82 etc) Aneroids (82 etc)	K955342 (1996)
TELEFLEX INCORPORATED Present in Europe in other categories	United States	RUSCH HUDSON RCI ARROW GIBECK PILLING	registered
W. A. BAUM CO., INC.	United States	BAUM	registered
Statcorp Medical	United States	Trulink Ultracheck SoftCheck Tru	K152801 (2015)
SUNSET HEALTHCARE SOLUTIONS, INC.	United States	Oxygen Connector/Adapter Respiratory Accessory Nasopharyngeal Airway Oxygen Connector Connector/Adapter Tubing Connectors	registered
Avante	–	Integra SL Integra SP VS02 Integra SL3 Waveline Pro+ Waveline EZ-MAX Waveline Touch+	registered
GRAPHIC CONTROLS ACQUISITION CORP	–	Vermed VersaTrode™ PerformancePlus™ Z-Brand™ ClearScan™ SilveRest™	registered
BOUND TREE MEDICAL, LLC	–	Curaplex Curaplex®	registered
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.	–	Merit Medical® PT12(30CM) PT 84M(210CM) CRITIFLO(TM) TA1017M (3ML/HR) COMP PRLINE MF 100CM RED PT60M(150CM)	registered
Sleepnet Corporation	United States	Ascend Full Face Vented Mask, Small Ascend Full Face Vented Mask, Large Mojo Full Face Mask, Extra Large with Headgear Ascend Full Face Vented Mask System Mojo Full Face Mask, Medium with Headgear Ascend Full Face Vented Mask, Medium	K251847 (2026)
OWENS & MINOR DISTRIBUTION, INC.	–	MediChoice Halyard	registered
SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories	–	Spacelabs Healthcare BleaseFocus 900 Series Ventilator BleaseGenius Spacelabs Ultraview	registered
ATHENA GTX, INC.	United States	Athena GTX Device Management Suite (ADMS) Software WVSM Pro, Wireless Vital Signs Monitor Professional WVSM Wireless Vital Signs Monitor	K233354 (2024)
Philips Medical Systems Hsg	–	ECG Electrodes Care Assist Microstream Advance Adult Oral-Nasal CO2 Filter Line Microstream Advance Pediatric Oral-Nasal CO2 Filter Line Microstream Advance Adult Nasal CO2 Filter Line Microstream Advance Adult-Pediatric Intubated CO2 Filter Line	registered
LUTECH INDUSTRIES INC Present in Europe in other categories	United States	Lutech	K150691 (2015)
PMT CORPORATION	United States	PMT CORPORATION INTERCONNECTION CABLE PMT® CORPORATION	registered
Airlife, Inc.	United States	AirLife™ Airlife Vital Signs™ SuperNO2VA Halyard Gas Sampling Line Vyaire	K834570 (1984)
FLEXICARE MEDICAL LIMITED Present in Europe in other categories	United Kingdom	Neoforce Infant Resuscitation Kit. T-Piece Circuit Infant Resuscitation Kit T-Piece Circuit Infant Resuscitator T-Piece Catheter Access Adapter Infant Resuscitation Kit T-Piece Circuit 1.8m (70") with Anatomical Mask Size 1 Infant Resuscitator T-Piece Circuit with Adjustable PEEP	K201666 (2020)
Oridion Medical 1987 , Ltd.	Israel	Omnistream Microstream Microstream Advance Microstream Luer Surestream Capnostream20p	K200594 (2020)
Ad-Tech Medical Instrument Corporation Present in Europe in other categories	United States	Lightweight CABRIO Cable SIGNUM Connection System Cable Lightweight TECH-ATTACH Cable TECH-ATTACH Connection System Cable TECH-ATTACH Disposable Connector Block FO TECH-ATTACH Connection Cable	registered
ANESTHESIA ASSOCIATES, INC.	United States	AincA® AincA	registered
MED-DYNE, INC.	United States	Med-Dyne	K080112 (2008)
Rudolf Riester GmbH & Co. KG	Germany	ri-fox N, pulse oximeter RVS-100 RVS-100,NIBP(Riester)+SpO2(Riester) + Pred. Temp exacta® metal, black, obese size velcro cuff exacta® metal, black, adult size velcro cuff sanaphon® with stethoscope, child size velcro cuff pull through strap	K190927 (2019)
Conmed Corporation Present in Europe in other categories	United States	CLEARTRACE SOFTRACE CONMED SURETRACE POSITRACE TOTALTRACE	P200004 (2022)
Shenzhen Vistar Medical Supplies Co.,Ltd.	China	Vistarmed ELERA K152468	K152465 (2015)
Intl. Medical, Inc.	United States	BV Medical School Health	K896633 (1990)
METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETI	Türkiye	FMT	registered
Boston Scientific Corp Present in Europe in other categories	United States	LABSYSTEM™ PRO RHYTHMIA HDx™ Cable, SureLink™ Cable, Easy-Mate™ Electrode Cable AVVIGO™+	K260771 (2026)
Carefusion 303, Inc.	United States	Pyxis Pro MedStation BD Pyxis Pyxis BD Pyxis™ Pyxis MedStation BD Alaris™ ETCO2 Module, Model 8300	K243855 (2025)
Ivy Biomedical Systems, Inc. Present in Europe in other categories	United States	Model 7600 Model 7800 Model 7600EP Model 7700 CTM-300 UPMM	K240087 (2024)
MERCURY ENTERPRISES, INC.	–	Neo-Tee T-Piece Resuscitator Neo-Tee T-Piece Resuscitator Circuit Resusa-Tee T-Piece Resuscitator Neo-Tee Tubing Kit Flow-Safe Disposable CPAP System Flow-Safe II Disposable CPAP System	registered
WESTMED, INC.	United States	WaterPAP Pole Clamp Bracket with Tube Guide WaterPAP Pro WaterPAP Neo-Vent Infant T-Piece Resuscitation Circuit, Gas Supply Adaptors/Connectors	K162343 (2016)
Hans Rudolph, Inc.	United States	7600 V MASK 7500 V MASK	K071149 (2008)
Mediaid, Inc.	United States	Reusable Sensor - Pedi Finger Reusable Sensor - Y Reusable Sensor - Ear Reusable Sensor - Adult Finger Reusable Sensor - Soft Adult Reusable Sensor - Soft Pedi	K071642 (2008)
PEDIGO PRODUCTS, INC.	United States	Pedigo Products, Inc.	registered
Amico Diagnostic Incorporated Present in Europe in other categories	United States	Amico Diagnostic Cuff Amico Diagnostic Station Amico Diagnostic Aneroid Amico Diagnostic Wallboard Amico Diagnostic Rollstand	registered
Norav Medical , Ltd. Present in Europe in other categories	Israel	Norav 1200 Series PC-ECG Norav 1200 Series ECG Wireless BT 12 lead resting ECG. Telemetry System. License + Software for up to 7 users 12 lead ECG for rest.	K110463 (2011)
Instrumentation Industries, Inc. Present in Europe in other categories	United States	Pilot Tube Repair Kit Manual Jet Ventilator BE 142-A BE 142 BE 30-142 BE 106 Adult Adapter with Vent	K180510 (2019)
MEDTRONIC PS MEDICAL, INC.	United States	Becker® Exacta™ Duet® Becker	K983799 (1999)
Maguire Enterprises, Inc.	–	MAGUIRE Cable CV200101	registered
PERMA PURE LLC	–	Perma Pure Nafion Dryer	registered
Tekscan, Inc. Present in Europe in other categories	United States	BPMS Evolution Strideway SR Tile Strideway HR Tile Strideway MR Tile HR Walkway VersaTek MatScan Evolution	registered
St Jude Medical	United States	PressureWire™ Wi-Box™ SJM™ myMerlin™ Merlin.net™ QUANTIEN™	K161171 (2016)
DISPO-MED (MALAYSIA) SDN. BHD.	Malaysia	DISPO-MED Dispo-Med Nasal/Oral Dual CO2 Samp.Cannula W/O2,Adult,MLL,Tube 7ft W/Filter Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 7ft Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery,Adult, MLL, Tube 7ft W/Filter Dispo-Med Anaesthetic Gas Sampling Line, MLL, Tube 7ft Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Adult,MLL,Tube 10ft	K143127 (2015)
STRYKER SUSTAINABILITY SOLUTIONS, INC.	United States	Medtronic Baylis Medical NRG Intellanav Ablation Cable	K211140 (2022)
C.M.P. Canadian Medical Products Inc	Canada	C.M.P. Cable C.M.P. Cables	registered
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson SunMark	registered
Leonhard Lang GmbH	United States	S&W Skintact Trace1 Stable Base GE Healthcare	K142803 (2014)
MDF Instruments Medifriend Inc. Present in Europe in other categories	China	MDF®	registered
Analytical Industries, Inc.	United States	Analytical Industries Inc.	K053407 (2006)
RPI	–	PATIENT CABLE - 3 LEAD DN SKIN TEMP PROBE (REUSABLE) PATIENT CABLE - 10 LD FX BN SKIN TEMP PROBE - 10 PATIENT CABLE - 3 LEAD DU PATIENT CABLE-5 LEAD DU	registered
VENTLAB, LLC	United States	Ventlab	K173373 (2018)
R & D Batteries, Inc.	United States	R&D Batteries, Inc.	K141795 (2014)
Dynarex Corporation	United States	Resp-O2 CPAP Tubing 6' ( 1.8 m ) Resp-O2 CPAP Tubing 4' ( 1.2m ) Resp-O2 CPAP Tubing 8' ( 2.4 m ) Resp-O2 Nasal O2 Cannula Cushion Tip Resp-O2 Nasal O2 Cannula Super Soft Touch Resp-O2 Nasal O2 Cannula Standard Tip	registered
INNOVATIVE HEALTH LLC	–	–	registered
NAVILYST MEDICAL, INC.	United States	NAMIC	registered
Pentax of America, Inc. Present in Europe in other categories	United States	ENDOPRO IQ EXTRON ENDOPRO NETWORK CAPTURE WORKSTATION TV ONE ENDOPRO STANDALONEC CAPTURE WORKSTATION	registered
SENSORONICS INCORPORATED	–	Sensoronics Sesoronics	registered
Ventec Life Systems, Inc.	United States	VOCSN High Flow Kit VOCSN Patient Breathing Package VOCSN VOCSN Nurse Call Cable VOCSN Roll Stand VOCSN Patient Air Intake Filters	K162877 (2017)
ADVANCED INSTRUMENTATIONS, INC.	United States	ADVANCED GAS-MACHINE ANESTHESIA ADVANCED VENTILATOR ADVANCED PATIENT MONITOR ADVANCED VITAL SIGNS MONITOR ADVANCED CENTRAL MONITORING STATION ADVANCED INFUSION PUMP	K132077 (2014)
FIAB SPA Present in Europe in other categories	Italy	F3001ECG SENSITHERM MULTI ESOTEST MULTI ADAPTER CABLE	registered
AngioDynamics, Inc.	United States	PulseSpray UniFuse Uni-Fuse+	registered
Rising Eagle Medical LLC	–	MEDALink 9Line	registered
MEDIMAX TECH INC.	–	MediMax Tech	registered
Drive Devilbiss Healthcare	United States	ROSCOE DRIVEMEDICAL Drive Roscoe Medical Carex Health Brands Noridian Healthcare	registered
ALPHA SOURCE INC.	–	ALPHA SOURCE BATTERY	registered
CABLES AND SENSORS, LLC	United States	Masimo Compatible Disposable SpO2 Sensor, Neonate Disposable Cuff, Thigh, Double Hose, BP48 Connector, Box of 5 Wellch Allyn Compatible SOFT-12L FlexiPort Disposable NIBP Cuff, Box of 20 Disposable NIBP Cuffs with BP03 Connector Infant Single Hose, Bag of 10 Welch Allyn Compatible REUSE-13 FlexiPort Reusable NIBP Cuff Neonate #4 Disposable Cuff Slip Double Hose Connector Box of 10	registered
Cardiac Science Corporation	United States	Powerheart AED G3 Pro ECG Monitoring Cable Powerheart® AED G3 Pro AED Powerheart® AED G3 Plus Automatic AED Powerheart® G3 Battery Intellisense Adult Defibrillation Pads, Powerheart® G5 Powerheart® AED G3 Automatic AED	K143714 (2015)
VERIDIAN HEALTHCARE LLC	–	Veridian Zewa Welby SmartHeart Hello Heart Trackstar	registered
Cook, Inc.	United States	CXI Cantata CrossCath TriForce Cook Slip-Cath	K182071 (2019)
GALEMED CORPORATION Present in Europe in other categories	Taiwan	Neb.Plus Durable Straight Connector 7.6M, 4.3F barb Babi.Plus JITTO galemed	K133957 (2014)
Southmedic, Inc.	Canada	Vapofil™ Antispil Quik Fil OxyArm™ Oxy2Mask O2/EtCO2 Capnoxygen®	K222511 (2023)
VYAIRE MEDICAL, INC. Present in Europe in other categories	United States	AirLife™ Vital Signs™ AirLife AirLife™ Adult Oxygen Mask Vinyl, Under the Chin Style Multi-Link™ Broselow	K230915 (2024)
TYROLMED GmbH	–	SWAROMED	registered
Honsun (Nantong) Co., Ltd.	China	SCIAN Welby LotFancy E+R 中性 Dittmann	K262658 (2026)
AirLife Finland Oy Present in Europe in other categories	–	Vital Signs™	registered
IT Dr. Gambert GmbH Present in Europe in other categories	Germany	O2-Sensor	registered
Circadiance, LLC	United States	SleepWeaver Elan - Mask & Headgear - Regular - Beige NeoPAP Cannula - XS SleepWeaver Elan - Mask & Headgear - Small - Beige SleepWeaver Elan - Mask & Headgear - Large - Pink SleepWeaver Elan - Mask & Headgear - Regular - Leopard NeoPAP Customer Trial Pack	K162905 (2017)
STRYKER CORPORATION Present in Europe in other categories	United States	Procedural Oxygen Mask POM EZ-Lite Pedi-POM EZ MM Pedi-POM EZ-Lite Pedi-POM EZ MF POM EZ-Lite MF	K771199 (1977)
BESMED HEALTH BUSINESS CORP. Present in Europe in other categories	Taiwan	PEEP VALVE 20cmH2O Non-Rebreathing Valve with Manometer Port (L Type) PEEP VALVE 12.5cmH2O PEEP VALVE 10cmH2O DISPOSABLE PEEP VALVE 5-20cmH2O, BLUE, ID:30mm PEEP VALVE 2.5cmH2O	K160112 (2016)
Iradimed Corporation	United States	Iradimed	K242752 (2025)
ORICARE INC.	United States	A9800 Anesthesia Workstation V8800 Critical Care Ventilator	K131790 (2014)
GF HEALTH PRODUCTS, INC. Present in Europe in other categories	United States	JOHN BUNN LUMISCOPE LabTron GRAHAM FIELD GAHAM FIELD Grafco	registered
MOBERG RESEARCH INC	United States	Component Neuromonitoring System Component Monitoring System CNS Envision	K080217 (2008)
TRI-ANIM HEALTH SERVICES, INC.	–	Curaplex	registered
Go Medical Industries Pty. , Ltd.	Australia	Flow Control Tubing Springfusor	K910007 (1993)
RAULAND-BORG CORPORATION	–	Responder	registered
HOPKINS UNIFORM COMPANY	–	Hopkins Medical Products® Hopkins Medical Products Handheld Pulse Oximeter	registered
Mortara Instrument, Inc.	United States	Patient Cable X12+ Patient Cable Surveyor S4 Q-Tel RMS Surveyor Patient Cable Quik-Prep	K182297 (2019)
MERIT CABLES INCORPORATED	United States	Patient Leadwire Patient Cable Patient Lead Wire Set Patient Lead Wire Patient Leadwire Set Patient Leadwire Set of 5	K942321 (1994)
Authentic Medical	United States	SureLead	K181089 (2020)
Micro Therapeutics, Inc.	United States	Rebar PhenomTM 17 Catheter RebarTM Echelon PhenomTM 27 Catheter MarksmanTM	K113289 (2012)
Fysicon B.V. Present in Europe in other categories	Netherlands	QMAPP	K241766 (2025)
Summa Therapeutics, LLC	United States	Finesse BTK Multicath	registered

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