Instruments for functional explorations and therapeutic interventions

Various instruments for functional exploration and therapeutic interventions

EMDN code Z1290

188 manufacturers, 548 models including 546 on the market, 28 countries

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

Manufacturers registered in Europe (EUDAMED) 188

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
Designs for Vision FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	4902-3003-1012 4929-3003-1002 4929-3003-1012 4932-3000-1002 Adapter, USB Switchcraft 4912-0000-0011 79 others Battery Pod Kit,Wireless-3 Pod 4906-0000-3001 Bracket Assy, Extension Arm & Infinity TS 4908-0023-0000 Bracket Assy, Orascoptic ROH Elite/Ergo Edge 4708-0026-0000 Bracket Assy, Universal 4908-0004-0000 Bracket Assy, Yeoman “T” Mount 4908-0010-0000 Bracket Assy, Zeiss 4708-0018-0000 Cable Assy, LED Micro Left 4911-0000-0022 Cable Assy, LED Nano 4’5” w/Ty-Wrap Right 4901-0001-1122 Charger&Cord,3C 4709-0000-3019 Clip, Belt 4911-0002-0029 Common Platform, LED Daylight Dental Complete 4914-0000-0005 Cradle Assy, Wireless 4906-0000-0004 Foot Pedal Assy, Shield 4002-0001-0048 General Headlight GLS Hdset LED TwinBeam DV 4709-2000-0001 Headband Assy DVT Mount 4709-3000-0005 Holster, Power Pack Universal 0030-4912-0001 LED Classic DayLite Charger Universal 4912-0000-2019 LED DayLite 4.5 Cable Assy Right 4702-0001-0022 LED DayLite Battery Pod Assy 4906-0000-0001 LED DayLite Dental UltraMini HDi Complete 4902-3003-1002 LED DayLite Dental UltraMini HDi IR Basic 4932-3003-1012 LED DayLite Dental UltraMini HDi IR Complete 4932-3003-1002 LED DayLite HDi Optical Assy 4702-3000-0001 LED DayLite HDi Optical Assy 4702-3002-0001 LED DayLite HDi Ultramini HDi XQE/XRE Complete 4902-3002-0001 LED DayLite Micro Basic Common Platform 4911-0001-0005 LED DayLite Micro Cable Assy Right 4911-0001-0022 LED DayLite Micro Complete Common Platform 4911-0000-0005 LED DayLite Micro HDi Basic 4902-3002-1012 LED DayLite Micro HDi IR Basic 4932-3000-1012 LED DayLite Micro Standard Imaging Basic 4929-0000-0000 LED DayLite Micro Standard Imaging Complete 4929-0002-0000 LED DayLite NanoCam 4K Camera assembly only 4003-3004-0004 LED DayLite NanoCam GO Camera Complete 4003-3080-0004 LED DayLite NanoCam HD Camera Complete 4003-3000-0000 LED DayLite NanoCam HDi Headlight Complete 4003-3000-1002 LED DayLite Powerpack Assy 4914-0000-0001 LED DayLite REVEAL FC 9500-0000-0000 LED DayLite Surgical Charger + Cord 2C 4709-0000-2019 LED DayLite Surgical Complete Common Platform 4912-0000-0005 LED DayLite Surgical PowerPack Assy with Holster 4912-0001-0000 LED DayLite Surgical TwinBeam DV HDi Complete 4709-3000-1002 LED DayLite Surgical Ultra Mini HDi-Optical Assy 4902-3002-0021 LED DayLite Surgical Ultra Mini Headlight Assy 4902-0000-0002 LED DayLite Surgical UltraMini HDi Basic 4902-3000-1012 LED DayLite Surgical UltraMini HDi Complete 4902-3000-1002 LED DayLite Surgical UltraMini PS HDi Complete 4902-3001-1002 LED DayLite Surgical USB DayLite HDi Complete 4702-3000-1002 LED DayLite Ultra Mini CSV Standard Imaging Assy 4929-3002-0002 LED DayLite UltraMini CSV Standard Headlight Assy 4929-3000-0002 LED DayLite Ultramini Nano Dental Headlight Assy 4901-0000-0002 LED DayLite WireLess 4906-0000-0000 LED DayLite Wireless Battery 10440 350 mAh 4907-0000-1018 LED DayLite Wireless Battery 10440 350 mAh 4912-0000-0001 LED DayLite WireLess HDi IR 4916-3000-0000 LED DayLite Wireless HDi IR Optical Assy 4916-3001-0003 LED DayLite WireLess Mini 4907-0000-0000 LED DayLite Wireless Mini Cradle Assy 4907-0000-0004 LED DayLite WireLess Mini HDi 4907-0004-0000 LED DayLite Wireless Mini HDi Optical Assy 4907-0004-0002 LED DayLite Wireless Optical Assy 4906-0001-0003 LED NanoCam Go Surg UltraMini HDi Complete 4902-3180-1002 LED TriBeam DayLite Plus 4913-3002-0002 LED TriBram DayLite Yellow 4480-3000-1002 LED Wireless System Mini HDi 4907-0004-0000 Loupe/Light Combo CFG-LL-CB NanoCam 4K Complete with DayLite HDi 4702-3004-1002 NanoCam 4K Complete with Panoramic Spot PS Surgical HDi 4902-3004-1002 NanoCam 4K System without LED Headlight 4003-3004-0000 NanoCam Go Complete with Panoramic Spot PS Surgical HDi 4902-3080-1002 NanoCam Go System without LED Headlight 4003-3080-0000 Optical Assy, LED DayLite T-mount 4708-0008-0002 Optical Assy, Wireless Mini 4907-0001-0003 Plug & Cord, Japan 4706-0000-0037 Plug & Cord, U .K (English Fused) 4706-0000-0034 Plug Cord European 4706-0000-0030 PowerPack DayLite Micro 4911-0000-0001 TwinBeam HDi CXL Complete 4709-3005-1002	I MDR	Website EUDAMED record Report an error
Hpcosmos FDA	Germany	COSMED T170 DE 3p sportmed treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p)93/42 COSMED T170 DE MED treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 COSMED T170 DE sportmed treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 COSMED T200 M treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 COSMED T200 S treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 58 others COSMED T250 MR treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 250CE 170/65 treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 LE 300CE 170/65 treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 LE 500CE 170/65 treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 LE 580CE 200/75 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 580CE 200/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 590CE 200/100 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 590CE 200/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 600CE 250/75 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 600CE 250/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 650CE 250/100 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 650CE 250/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 680CE 250/125 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 690CE 300/75 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 690CE 300/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 700CE 300/100 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 700CE 300/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 LE 720CE 300/125 R treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 locomotion 190/65 DE med treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 locomotion® 150/50 DE med treadmill h/p/cosmos 150/50 (locomotion)93/42 locomotion® 190/65 3p DE med treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p)93/42 locomotion® 190/65 3p E med treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p)93/42 locomotion® 190/65 E med treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 mercury® med OEM treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 mercury® med treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 mercury® med treadmill h/p/cosmos 150/50 G7 (pluto, mercury)3 refs pluto med treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 pluto® ef med treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 pluto® lt med OEM treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 pluto® lt med treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 pluto® med OEM treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 pulsar lt med treadmill h/p/cosmos 170-190/65 MCU63 refs pulsar lt treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 pulsar® lt 3p treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p)93/42 quasar lt med treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 quasar med treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 quasar® med 3p treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p)93/42 saturn® 250/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 250/100r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 250/125r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 250/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 250/75r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 300/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 300/100r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 300/125r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 300/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 saturn® 300/75r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 stellar med treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 stellar® lt med treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 stratos® med treadmill h/p/cosmos 150/50 (pluto, mercury)93/42 torqualizer® 1200 med2 refs treadmill h/p/cosmos 150/50 (pluto, mercury)13 refs93/42 treadmill h/p/cosmos 170-190/65 (quasar, pulsar)93/42 treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p)93/42 venus® 200/100 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 venus® 200/100r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 venus® 200/75 treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42 venus® 200/75r treadmill h/p/cosmos 200-300/75-125 (venus, saturn)93/42	IIa, IIb MDR, 93/42	Website regulatory.affairs@hpcosmos.com EUDAMED record Report an error
Micare FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	E500 E500 (L) E500/500 E700 (L) E700 SINGLE CEILING LED SURGICAL LIGHT 41 others E700/500 E700/700 E700G JD1000G JD1000L EXAMINATION LIGHT JD1100 JD1100L JD1200J JD1200L JD1300G JD1300J JD1300L JD1400G JD1400J JD1400L JD1500 JD1500G JD1500J JD1500L JD1600J JD1600L JD1700G JD1700J JD1700L JD1800 JD1800G JD1800J JD1800L JD1900G JD1900J JD1900L JD2000 JD2100 JD2200 JD2300 JD2400 JD2500 JD2600 JD2700 JD2800 JD2900	I MDR	info@micare.cn EUDAMED record Report an error
Arcmed	Türkiye	Double-Arm Motorized Anesthesia Pendant PND-MC-A93/42 Double-Arm Motorized General Purpose Pendant PND-MC-G93/42 Double-Arm Motorized Surgical Pendant PND-MC-C93/42 Double-Arm Non-Motorized Anesthesia Pendant PND-CM-A93/42 Double-Arm Non-Motorized Anesthesia Pendant PND-CM-C93/42 12 others Double-Arm Non-Motorized General Purpose Pendant PND-CM-G93/42 Non-Motorized Anesthesia Pendant PND-M-A93/42 Non-Motorized General-Purpose Pendant PND-M-G93/42 Non-Motorized Surgical Pendant PND-M-C93/42 Single-Arm Motorized Anesthesia Pendant PND-MT-A93/42 Single-Arm Motorized General Purpose Pendant PND-MT-G93/42 Single-Arm Motorized Surgical Pendant PND-MT-C93/42 Single-Arm Non-Motorized Anesthesia Pendant PND-TM-A93/42 Single-Arm Non-Motorized General Purpose Pendant PND-TM-G93/42 Single-Arm Non-Motorized Surgical Pendant PND-TM-C93/42 Vertical Anesthesia Pendant PND-V-A93/42 Vertical Surgical Pendant PND-V-C93/42	IIb 93/42	Website EUDAMED record Report an error
CAO Group FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Monet + Curing Laser 001-00123 Monet Curing Laser 001-00105 Monet Curing Laser 2mm Aperture Monet Curing Laser 4mm Aperture Monet Curing Laser 6mm Aperture 7 others Monet Curing Laser Aperture Multi-Pack Monet Curing Laser Attenuator Aperture Monet Curing Laser Barrier Sleeve Monet Curing Laser Battery Charger Monet Curing Laser Battery Pack Monet Curing Laser Power Supply Monet Curing Laser Shield Cap2 refs	I MDR	Website info@caogroup.com EUDAMED record Report an error
Natus FDA EU representative : Natus Manufacturing Ltd (Ireland)	Canada, Denmark	1077 Madsen Accuscreen3 refs Algo 3i 0107263 refs Echo SCreen III Accessories 0110103 refs Flexicouplers 0114453 refs Flexicouplers and Jelly Tab Sensors 20 PKG/60 Count Tab Electrode Package3 refs 5 others LED Photic Stim Plus Roll Stand (50 Hz) - 220V LED Photic Stim w/o Stand (50 Hz) - 220V3 refs Madsen Alpha3 refs OAE EarTips OAE EAR TIP3 refs Protektor32 Pods and Pod Kit P32 ACQ Pod combine kit3 refs Protektor32 Visual Stim LED Goggles	I, IIa MDR	Website EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	Ceiling Pendant D54 refs Ceiling Pendant D693/42 Ceiling Pendant D793/42 Ceiling Pendant D893/42 LED Surgical Light L693/42 5 others LED Surgical Light L6A93/42 LED Surgical Light L6B93/42 LED Surgical Light L6SC93/42 LED Surgical Light L6SCA93/42 LED Surgical Light L6SCB93/42	I, IIb MDR, 93/42	EUDAMED record Report an error
Heine FDA	Germany	EL3 LED Finoff 2,5 V LOUPEL.2 F.HR/HRP+MPACK MINI mini-c D-008.73.109 mini-e D-008.73.103 4 others mini-f D-008.73.110 ML4 LED Polarisation filter P2 for LoupeLights/MicroLights2 refs Yellow filter for LoupeLights/MicroLights2 refs	I MDR	Website info@heine.com EUDAMED record Report an error
MTG	Germany	Cura-H93/42 Cura-V93/42 Integra93/42 Ligno-H93/42 Ligno-V93/42 3 others Optima93/42 Verso93/42 Verso-OP93/42	IIb 93/42	Website info@mtg-gmbh.de EUDAMED record Report an error
Lewinmed EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Creport 3000 Creport 3500 Creport 3700 Creport 3900 Creport 5500 2 others Creport3000(A) Creprot 5000	I MDR	Website EUDAMED record Report an error
Univet Loupes FDA	Italy	DELIGHT WIRELESS EOS 2.0 EOS NEXT EOS WIRELESS A LYNX 1 other LYNXPRO	I MDR	EUDAMED record Report an error
Donga EU representative : mdi Europa GmbH (Germany)	South Korea	CLS-S7 FX-V1 FX-V3 V1 SMART V1 SMART MINI	I MDR	Website EUDAMED record Report an error
Dongguan Q & S Electronic Manufacturing EU representative : MedNet EC-REP GmbH (Germany)	China	Beurer TL100-(BEG005)93/42 Beurer TL50-(BEG007)93/42 Beurer TL70-(BEG006)93/42 TLW001-(LM1700)93/42 TLW002-(FW400)93/42	IIa 93/42	Website EUDAMED record Report an error
Hefei Mt Medical FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	CR,CR-1,CR-2,CR-3,CR-4,CR-5,CR-6,CR-7,CR-8,CR-9,CR-10,CR-11,CR-12,CR-11,CR-12,CR-13,CR-14,CR-15,CR-16,CR-17,CR-18,CR-19,CR-20，CR-21,CR-22,CR-23,CR-24,CR-25，CR-26,CR-27,CR-28,CR-29,CR-30,CR-31,CR-32,CR-33,CR-34 MT-EL01A，MT-EL01B，MT-EL01C，MT-EL02A，MT-EL02B，MT-EL02C，MT-EL03A，MT-EL03B,MT-EL03C,MT-EL04，MT-EL05A，MT-EL05B，MT-EL05C，MT-EL06A,MT-EL06B,MT-EL06C，MT-EL07A，MT-EL07B，etc.3 refs MT-OEB01,MT-OEB02,MT-OEB03,MT-OEB04,MT-OEB05,MT-OEB06,MT-OEB07,MT-OEB08,MT-OEB09,MT-OEB10,MT-OEB11,MT-OEB12,MT-OEB13,MT-OEB14,MT-OEB15,MT-OEB16,MT-OEB17, etc.3 refs Operation Lamp MT-SL500D3 refs YDE700/500,YDE700/700,YDE500/500,YDE700,YDE500,YDE500D,YDE700/500 A,YDE700/700 A,YDE500/500 A,YDE700 A,YDE500 A,YDE500D A， etc3 refs	I MDR	info@xn--mtmedical-w79d.com EUDAMED record Report an error
ITD FDA	Germany	Flexion-port 300 Schwenkarm ITD-Profil lf-port mf-port KN.2036.991 modul-port rm-port	I MDR	Website sales@itd-cart.com EUDAMED record Report an error
Alliage S/A Indústrias Médico Odontológica FDA EU representative : ELS SOLUTIONS GDIA - UNIPESSOAL LDA. (Portugal)	Brazil	Dental Light Persus LED Dental Light SIRIUS G8 SENS 5 LEDS Dental Light SIRIUS G8 SENSOR 3 LEDS Dental Light SIRIUS G8 SENSOR 5 (3X2) LEDS	I MDR	Website EUDAMED record Report an error
Karlstorz FDA	Germany	Headlights2 refs Lamp heads2 refs Lamp heads, fiber optic3 refs Sockets3 refs	I MDR	Website regulatory@karlstorz.com EUDAMED record Report an error
Long Island Technology Group FDA EU representative : Obelis s.a. (Belgium)	United States	AtoN™ Fiber Optic Headlight P003200 Bristol P0026002 refs Daymark P0030602 refs Dover P0025002 refs	I MDR	Website EUDAMED record Report an error
Neitz FDA EU representative : MDSS GmbH (Germany)	Japan	NSI-X 100 mm Type 120V NSI-X 100 mm Type 230V NSI-X 80 mm Type 120V NSI-X 80 mm Type 230V	I MDR	Website EUDAMED record Report an error
Normagrup	Spain	ARDYS3 refs ARDYS-PLUS3 refs NEOS3 refs UCI-OVAL	IIb MDR	Website eudamed@normagrup.com EUDAMED record Report an error
Ordisi	Spain	FLH2131 FLH-23 refs FLH311 FLH-33 refs IG-100C3 refs L21-25P3 refs	I MDR	Website EUDAMED record Report an error
Tedisel	Spain	ABITUS3 refs B-ABITUS3 refs B-ADONIS3 refs SICA93/42	I, IIb MDR, 93/42	Website info@tedisel.com EUDAMED record Report an error
Baxter FDA	Germany	FCS 300 Electro Cube FCS 500 Ceiling Carrier HL Solo/TanPrep3 refs FCS 700 Ceiling Supply Unit Solo/TanPrep2 refs	I, IIb MDR	Website EUDAMED record Report an error
Bryant FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	BD RH2 - Surgical Binoculars – Reusable BD2 Ignis Halo BR19	I MDR	Website EUDAMED record Report an error
Dentmate FDA EU representative : KOMAS Medical Technology GmbH (Germany)	Taiwan	Examination Light LUMINDEX 3 Examination Light LUMINDEX 3 Plaque Headlight	I MDR	Website info@dentmate.com.tw EUDAMED record Report an error
Dong Guan Gang Mei Optical FDA EU representative : INDIAN EYEWEAR MADRID S.L. (Spain)	China	VOVCT24C1 VOVJR 19 C1 VOVJR 20 C1	I MDR	EUDAMED record Report an error
E-Swin FDA	France	E>075 D006AF001A12A93/42 E>One Clinic Evolution93/42 WE>O93/42	IIa 93/42	Website contact@e-swin.com EUDAMED record Report an error
Good Doctors FDA EU representative : Good Doctors Germany GmbH (Germany)	South Korea	Dr's Light CL-DL10 Dr's Light PRIME CL-DP40 Drs Light Claver CL-DC20	I MDR	EUDAMED record Report an error
Hospital Technical Solutions	Romania	HOSPICARE CPU CPUA93/42 HOSPICARE UT UTO1393/42 HOSPILUX LDL1293/42	IIb 93/42	Website EUDAMED record Report an error
I.C.LERCHER-Solutions FDA	Germany	ALU-CURVED - LED-LIGHT3 refs DIA-STICK Set2 refs STROBO-LIGHT Set	I MDR	info@icl-s.de EUDAMED record Report an error
Motek Medical FDA	Netherlands	C-Mill VR+ VR+ 300 x 100cm with BWS CAREN Extended – Installed in pit, 250cm Projection Screen, standard speed treadmill2 refs GRAIL with 250cm high projection screen	I MDR	Website EUDAMED record Report an error
Nomics	Belgium	Brizzy NS12193/42 Brizzy+ NS12693/42 Somnolter NS11393/42	IIa 93/42	Website sales@nomicscare.com EUDAMED record Report an error
Rolence FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Taiwan	Dental Curing Light 1000E 1000E, 1800E2 refs Dental Curing Light Q-4 Dental Curing Light Q-6, Q6-NLG	I MDR	Website EUDAMED record Report an error
Technogym	Italy	EASY ACCESS KIT SKILLRUN REV A0001483 RUN REV DFKRAA0 SKILLRUN REV DJJRAQ0	I, IIa MDR	prrc@technogym.com EUDAMED record Report an error
THD FDA	Italy	THD LED SOURCE USB THD PEN-LIGHT THD PORTABLE LIGHT	I MDR	regulatory@thdlab.com EUDAMED record Report an error
Welch Allyn FDA EU representative : Welch Allyn Limited (Ireland)	United States	Green Series 300 General Exam Light 9010673 refs KleenSpec 9010703 refs Single-Use Sheath for Exam Light 9010142 refs	I MDR	Website EUDAMED record Report an error
Alltion FDA EU representative : Obelis s.a. (Belgium)	China	AEL-100F AHL-50	I MDR	Website sales@alltion.com EUDAMED record Report an error
Altomed FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Damato Illuminators A9520A93/42 Damato Illuminators A9520AC93/42	I 93/42	EUDAMED record Report an error
Atena Lux	Italy	AIRWALL CALL3 refs ARMONIA G3 refs	I, IIa MDR	Website info@atenalux.com EUDAMED record Report an error
Bittium FDA	Finland	Bittium APV202 refs Respiro 1 RIP Belt Patch3 refs	I, IIa MDR	Website EUDAMED record Report an error
Derungs EU representative : Derungs Medical GmbH (Germany)	Switzerland	AMALIA 2 B S83 refs OPTICLUX Hand 10-1 DL3 refs	I MDR	Website mailbox@derungs.swiss EUDAMED record Report an error
Dewimed FDA	Germany	DEWILUX 130 LED LC,130.000lx,4.900K,Ra96 Lightfield d10 (1m): 150-280mm, 3-pole, LED Lifetime 50.000hrs3 refs SET DEWILUX 130 LED lamp, 130 KLUX consisiting of:3 refs	I MDR	Website info@dewimed.de EUDAMED record Report an error
Dixion	Germany	DIXION Convelar 1605 LED DIXION Convelar 1607 LED	I MDR	Website info@dixion.de EUDAMED record Report an error
Dr. Fenyves und Gut Deutschland	Germany	MiniScreen Plus PL Viollier Patient Recorder3 refs PolyX Schlafdiagnose-System (LM)3 refs	IIa MDR	info@fg-deutschland.de EUDAMED record Report an error
Fazzini	Italy	DIAGNOSTIC LAMP3 refs MEDICAL AIDS GR1013 refs	I MDR	Website INFO@FAZZINI.IT EUDAMED record Report an error
Glamox	Norway	C61 MEDICAL-R3 refs C61 MEDICAL-S3 refs	I MDR	Website info@glamox.com EUDAMED record Report an error
Hilbro Instruments FDA EU representative : ANTEX MEDI SOLUTION (Germany)	Pakistan	Fiber Optic Light carrier for 32-110-52 60.0010.012 refs Headlights	I MDR	sales@hilbro-instruments.com EUDAMED record Report an error
Lifeward FDA EU representative : Obelis s.a. (Belgium)	Israel	Anti-Gravity Treadmill Neo+ Antigravity Treadmill Neo	I MDR	Website EUDAMED record Report an error
Lode FDA	Netherlands	Excalibur Sport Excalibur Sport PFM	I MDR	Website EUDAMED record Report an error
Lomar	Italy	Aura compact3 refs Combi Gas3 refs	I, IIb MDR	Website EUDAMED record Report an error
LumaDent FDA EU representative : Brilitas Pharmaceuticals EU OÜ (Estonia)	United States	airLUX Headlight Package PRE-ALX2 refs ProLUX Headlight Package: Best Value PRE-PLX-BV	I MDR	Website EUDAMED record Report an error
Luxamed FDA	Germany	5-feet stand for LED examination lamp, white, short3 refs Diagnostic penlight LED, black3 refs	I MDR	Website info@luxamed.de EUDAMED record Report an error
Maquet (Suzhou) EU representative : MAQUET GmbH (Germany)	China	M-SHIFT2 refs MODUEVO3 refs	I, IIa MDR	EUDAMED record Report an error
Mdfinstruments FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	MDF611 MDF631	I MDR	Website EUDAMED record Report an error
Meden	Poland	AXELERO I Cardio JZM Panel 2000 H,N,P,K	I, IIb MDR	Website eudamed@meden.com.pl EUDAMED record Report an error
Medical Data Technology	Belgium	DREAMSCAN 2 P82 refs	IIa MDR	Website contact@medatec.be EUDAMED record Report an error
Metrex Research EU representative : KERR ITALIA SRL (Italy)	United States	Loupe3 refs Spark Headlight3 refs	I MDR	Website EUDAMED record Report an error
Nopa FDA	Germany	nopa Kaltlichtquelle3 refs nopa Leuchte3 refs	I MDR	Website info@nopa.de EUDAMED record Report an error
Omicron-Laserage Laserprodukte	Germany	PDT665.2-200093/42 PDT665.4-200093/42	IIb 93/42	Website mail@omicron-laser.de EUDAMED record Report an error
Opt Surgisystems	Italy	TAK AQUILA GAS SOSPESA Pensili per sala operatoria e terapia intensiva3 refs TAK AQUILA Testaletto3 refs	IIb MDR	Website EUDAMED record Report an error
Optergo	Sweden	DeLight Battery unit 4.0 DeLight ProgBeam	I MDR	Website EUDAMED record Report an error
orangedental	Germany	spot-on cordfree spot-on nxt	I MDR	Website info@orangedental.de EUDAMED record Report an error
RDS	France	MultiSense® MK 1.0 MultiSense® PRODUCT	IIa MDR	EUDAMED record Report an error
Runner FDA	Italy	REHARUNNER 02/70 PC RUN2011/TR-PC3 refs RUN1400/T RUN700/T3 refs	IIa MDR	Website EUDAMED record Report an error
Saikangmedical FDA EU representative : Everbiz GmbH (Germany) and 1 other	China	AInno X222 refs SK-L201,SK-L202,SK-L204,SK-L205,SK-L206,SK-L207,SK-L208,SK-L210,SK-L212,SK-L213,SK-L260,SK-L261,SK-L262,SK-L274,SK-L275,SK-L276,SK-L226,SK-L278,SK-L227,SK-L275-M,SK-L203,SK-L323,SK-L316,SK-L317,SK-L318,SK-L319,SK-L320,SK-L321,SK-L322,SK-L325,etc3 refs	I MDR	Website EUDAMED record Report an error
Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny	Poland	Bieżnia ERT-200 Cykloergometr ERM-200	IIa MDR	Website EUDAMED record Report an error
Sifary FDA EU representative : Caretechion GmbH (Germany)	China	SOFTOUCH Lux-SFT2 refs Wireless Z, Wireless Z+2 refs	I MDR	Website info@sifary.com EUDAMED record Report an error
Vermeiren	Belgium	Kim Nathalie	I MDR	compliance@vermeiren.be EUDAMED record Report an error
Woodway FDA EU representative : Woodway GmbH (Germany)	United States	4Front Med Boost 2 CORE2 refs	I MDR	EUDAMED record Report an error
Xianju Zhengjie Medical Instrument EU representative : REP Europe GmbH (Germany)	China	MEDICAL PENDANT DYT-SB, DYT-DB, DYT-MZ, DYT-SQJ, DYT-DQJ, DYT-YY, DYT-ICU, JYT-MZ, JYT-SB, JYT-DB, JYT-SQJ, JYT-DQJ,JYT-YY, JYT-ICU OPERATING LIGHT	I MDR	admin@cnxjyc.com EUDAMED record Report an error
Ablymed	Norway	LYNG One	I MDR	Website info@ablymed.com EUDAMED record Report an error
Adamosrl	Italy	LAMP003 Examination Lamp3 refs	I MDR	Website info@adamosrl.com EUDAMED record Report an error
Admetec EU representative : Obelis s.a. (Belgium)	Israel	Flamingo Light and camera3 refs	I MDR	EUDAMED record Report an error
Aeonmed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Medical Supply Units CP6400/CP6500/CP8300/CP8400/CP85003 refs	IIa MDR	Website EUDAMED record Report an error
Aesculap FDA	Germany	Aesculap	I MDR	Website eudamed@bbraun.com EUDAMED record Report an error
Aidite FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Power light ADT-SWWLY390	IIa MDR	info@aidite.com EUDAMED record Report an error
Aiesi	Italy	LAMPADA DA VISITA LED SU STATIVO CON RUOTE	I MDR	COMMERCIALE@AIESI.IT EUDAMED record Report an error
Amcaremed EU representative : MedPath GmbH (Germany)	China	BED HEAD UNITS NTC300	I MDR	info@amcaremed.com EUDAMED record Report an error
Anping Guardian Medical Equipment FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Penlight AZ-PL	I MDR	Website info@splint.cn EUDAMED record Report an error
Aquakinetics Bewegung Im Wasser	Germany	Aquarider	I MDR	Website info@aqua-kinetics.de EUDAMED record Report an error
Atom Medical FDA EU representative : Emergo Europe B.V. (Netherlands)	Japan	InfaLite	I MDR	Website infoEU@atomed.co.jp EUDAMED record Report an error
Azistaindustries EU representative : Obelis s.a. (Belgium)	India	iScanBreast, AZM-011	I MDR	Website EUDAMED record Report an error
Bee-Light Solutions Spółka Z Ograniczoną Odpowiedzialnością	Poland	Wyrób Medyczny - ROSE N-ML MED ISO MPRM SH DALI IP65 CRI95 S 940 81 1200x300 ROSE MED2 refs	I MDR	EUDAMED record Report an error
Berchtold	Germany	Chromophare 08858250000749SL	I MDR	EUDAMED record Report an error
Better medical technology FDA EU representative : Lotus NL B.V. (Netherlands)	China	BT310A ,BT681E-500,BT681E-500/700	I MDR	Website sale1@better-med.com EUDAMED record Report an error
Biodex Medical Systems EU representative : Emergo Europe B.V. (Netherlands)	United States	GAIT TRAINER III, 230V3 refs	I MDR	EUDAMED record Report an error
Bionix FDA EU representative : Obelis s.a. (Belgium)	United States	Light Source	I MDR	Website EUDAMED record Report an error
Bistos FDA EU representative : Obelis s.a. (Belgium)	South Korea	BT-410A2 refs	I MDR	Website EUDAMED record Report an error
BODY PRODUCTS RELAX Pharma und Kosmetik	Germany	Diagnostikleuchte	I MDR	Website info@body-products.de EUDAMED record Report an error
Calmedica	France	memoMatrix	IIa MDR	Website contactus@calmedica.com EUDAMED record Report an error
Cardiomedeurope	Greece	Treadmill CMT2058	I MDR	Website EUDAMED record Report an error
ChoiceTech EU representative : AR Experts B.V. (Netherlands)	South Korea	BiLumiX® Gen.33 refs	I MDR	sales@choicetech.kr EUDAMED record Report an error
Circius Pharma FDA	Sweden	Tinearity G13 refs	IIa MDR	Website info@circiuspharma.com EUDAMED record Report an error
Conmed FDA EU representative : MDSS GmbH (Germany)	United States	CONMED3 refs	I MDR	Website CustomerExperience@conmed.com EUDAMED record Report an error
Diers FDA	Germany	DIERS pedogait	I MDR	Website EUDAMED record Report an error
Dongguan Kaiser Technology FDA EU representative : MedNet EC-REP GmbH (Germany)	China	LS20004 refs93/42	IIa 93/42	EUDAMED record Report an error
Duearity FDA	Sweden	Tinearity G13 refs	IIa MDR	Website EUDAMED record Report an error
Dufner Instrumente FDA	Germany	Handle for laryngeal mirror $30-30050-003 refs	I MDR	Website info@dufner-tuttlingen.de EUDAMED record Report an error
Dzmedicalesrl	Italy	GIRASOLE TESTALETTO3 refs	IIb MDR	Website info@dzmedicalesrl.com EUDAMED record Report an error
Enova Illumination FDA EU representative : Advena Limited (Malta)	United States	Enova Illumination6 refs	I MDR	support@enovaillumination.com EUDAMED record Report an error
Enraf-Nonius FDA	Netherlands	EN-Motion3 refs	I MDR	Website info@enraf-nonius.nl EUDAMED record Report an error
Eufoton FDA	Italy	HEADVIEW	I MDR	Website info@eufoton.it EUDAMED record Report an error
Eurosets FDA	Italy	SPRINK LED LIGHT	I MDR	Website EUDAMED record Report an error
EUSA Global FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	PORTALED LED020/4	I MDR	Website EUDAMED record Report an error
eveia	France	Pédalier EVEIA Medical3 refs	I MDR	Website EUDAMED record Report an error
ExamVision FDA	Denmark	ExamVision Light System Essential One3 refs	I MDR	Website Compliance@ExamVision.com EUDAMED record Report an error
Ezygain	France	EMA	I MDR	contact@ezygain.com EUDAMED record Report an error
Firefly Global FDA EU representative : MDSS GmbH (Germany)	United States	ES201	I MDR	Website sales@fireflyglobal.com EUDAMED record Report an error
Foshan SOCO Precision Instrument FDA EU representative : Lotus NL B.V. (Netherlands)	China	SCML05	I MDR	Website EUDAMED record Report an error
Framiral	France	Boule Optocinétique Stimulopt Framiral	I MDR	Website contact@framiral.fr EUDAMED record Report an error
Full Vision FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Trackmaster3 refs	I MDR	EUDAMED record Report an error
Ganshorn FDA	Germany	SanaBike 1000 Ergometer3 refs	I MDR	Website info@ganshorn.de EUDAMED record Report an error
Geister FDA	Germany	Kopflicht3 refs	I MDR	Website EUDAMED record Report an error
GM Instruments FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Accoson Examination Light2 refs	I MDR	Website EUDAMED record Report an error
Goldenall FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	GA100S/GA80S/GA60S/GA100/GA80/GA60/GA20/ AERO GSP8/AERO SP8/AERO S8/AERO GP8/AERO P8/AERO P8R/AERO 8/AERO 8R/AERO GSP5 etc3 refs	I MDR	EUDAMED record Report an error
Guangxi Visualtech S&T EU representative : Eunitor GmbH (Germany)	China	Medical LED light source ZLED-85001A、ZLED-60001A2 refs	I MDR	EUDAMED record Report an error
Guangzhou Ajax Medical Equipment FDA EU representative : MedNet EC-REP GmbH (Germany)	China	LED dental light Orion, Hubble, Hubble II, Amber, Amber II, Pebble, Pebble II, Leo, Libra3 refs	I MDR	EUDAMED record Report an error
Gulden Ophthalmics FDA EU representative : QbD RepS BV (Belgium)	United States	Color Fixation Sticks3 refs	I MDR	Website info@guldenophthalmics.com EUDAMED record Report an error
Hangzhou Hawk Optical Electronic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hand Light Source Set LED2 refs	I MDR	Website EUDAMED record Report an error
Hiprove EU representative : Caretechion GmbH (Germany)	China	PENLIGHT (Examination Light) HP-PL01	I MDR	Website EUDAMED record Report an error
Hospital & Homecare Medical Device China EU representative : SUNGO Europe B.V. (Netherlands)	China	G7-5 G7-6 G7-9 MG10031 MG10032 MG10033 (single connection,double connection,triple connection)	I MDR	sales6@aline-medical.com EUDAMED record Report an error
Inspital FDA	Germany	DOUBLE JOINT PENDANT FX40.05, FX40.10V, FX40.10S, FX40.15M, FX40.15D, FX40.20D, FX40.25M, SR10.22, SR10.32, SR10.33, FX41.03, FX41.07, FX40.15, FX40.10, FX40.20V, FX40.20, FX40.25, FX40.25M3 refs	I MDR	Website info@inspital.com EUDAMED record Report an error
Kimetec FDA	Germany	CBC Penlight LED3 refs	I MDR	Website info@kimetec.de EUDAMED record Report an error
Kirchner & Wilhelm FDA	Germany	Binokularlupe 2,5 x 420 mm für LED-Kopfleuchte Magnifiers, operating2 refs	I MDR	Website info@kawemed.de EUDAMED record Report an error
Klsmartin FDA	Germany	KLS Martin3 refs	I MDR	Website vigilance@klsmartin.com EUDAMED record Report an error
L. Molteni & C. dei F.lli Alitti - Società di Esercizio -	Italy	VULNOLIGHT 4.0	IIa MDR	Website EUDAMED record Report an error
L.M. Medical Division	Italy	ALVO CALLISTO Hanging units for the operating room and intensive care Bed head units3 refs	IIb MDR	Website info@lmmedicaldivision.com EUDAMED record Report an error
Lifelines FDA EU representative : Incereb Ltd (Ireland)	United Kingdom (ex Northern Ireland)	Photic Stimulator2 refs	I MDR	Website EUDAMED record Report an error
Luminous Global EU representative : be-on-market GmbH (Germany)	United States	Luminous Pro-Series Pink Luminous Breast2 refs	I MDR	EUDAMED record Report an error
Luxiona	Poland	AGAT CLEAN ISO NO FRAME LED CRI95 7200 SLMR EDD IP65 940 KRG5DK / 600X600	I MDR	Website EUDAMED record Report an error
Medfruition FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Dental Operating Light LEDlight Plus3 refs	I MDR	EUDAMED record Report an error
Medipia-Laa EU representative : AR Experts B.V. (Netherlands)	South Korea	NK LED Light	I MDR	EUDAMED record Report an error
MediTop FDA	Netherlands	Entermed Enterview III3 refs	I MDR	Website EUDAMED record Report an error
Meyosis	Türkiye	Ceiling Mounted Surgical Light MYS-STE13 refs	I MDR	Website info@meyosis.com EUDAMED record Report an error
Micro Intelligent Technology (Hunan) EU representative : Everbiz GmbH (Germany)	China	ARGOS LED-4000	I MDR	EUDAMED record Report an error
MicroPAD	Italy	GL2+2 refs	I MDR	Website info@micropad.it EUDAMED record Report an error
Minam Optics EU representative : AR Experts B.V. (Netherlands)	South Korea	LED Light	I MDR	Website EUDAMED record Report an error
Mnt Tıbbi Malzemeler San Tic Şti	Türkiye	MNT Alin Led Pro (Light Source)	I MDR	Website EUDAMED record Report an error
Morettispa	Italy	LAMPADA DIAG. TASC. C/P.ABB. C/PILE BIA. SANITARI3 refs	I MDR	Website info@morettispa.com EUDAMED record Report an error
Mrc Systems Medizintechnische Systeme FDA	Germany	MR Light LED MRCAM-LED2 refs	I MDR	Website info@mrc-systems.de EUDAMED record Report an error
Nanjing Ludao Medical Technology EU representative : Everbiz GmbH (Germany)	China	operating lamp LD-Z200-12A, LD-Z200-12B, LD-Z200-12C, LD-Z300-24A, LD-Z300-24B, LD-Z300-24C, LD-Z400-36A, LD-Z400-36B, LD-Z400-36C, LD-Z500-48A, LD-Z500-48B, LD-Z500-48C.	I MDR	EUDAMED record Report an error
NICO FDA EU representative : Atlantico Systems, Ltd. (Ireland)	United States	NICO Myriad SPECTRA2 refs	I MDR	Website info@NICOneuro.com EUDAMED record Report an error
Optomic FDA	Spain	OP-HL CAM3 refs	I MDR	Website prrc@optomic.com EUDAMED record Report an error
Orthoheal FDA EU representative : AF Pharma Service Europe SL (Spain)	India	RizyCure2 refs	I MDR	Website contact@orthoheal.com EUDAMED record Report an error
Otopront FDA	Germany	LED Headlight otopront	I MDR	Website info@otopront.de EUDAMED record Report an error
PENTAX Medical FDA EU representative : PENTAX Europe GmbH (Germany)	Japan	PENTAX LED Light Source BS-LL1 See UDI-DI information for model names2 refs	I MDR	Website info.emea@pentaxmedical.com EUDAMED record Report an error
Philips FDA	Germany	VitalSky system93/42	IIa 93/42	eudamed@philips.com EUDAMED record Report an error
Praxis Medical Network	Italy	PEDALIERA PER RIABILITAZIONE DOPPIA FUNZIONE IN ACCIAIO CROMATO PEDALIERE PMN3 refs	I MDR	Website info@praxismedicalnetwork.com EUDAMED record Report an error
Premis	Netherlands	Premis Medical B.V.	I MDR	Website EUDAMED record Report an error
President Dental	Germany	ZENOLITE- Curing light-5 programme Max Power 2700 mW	I MDR	Website info@presidentdental.com EUDAMED record Report an error
RAM	Italy	TREADMILL ATHLETE 870C RAM TREADMILL3 refs	I MDR	EUDAMED record Report an error
REDA Instrumente FDA	Germany	Lichtquelle / Light source3 refs	I MDR	Website EUDAMED record Report an error
Reha-Stim Medtec FDA	Germany	GT II	IIa MDR	Website EUDAMED record Report an error
Rexuma	Sweden	BHU93/42	IIa 93/42	Website info@rexuma.se EUDAMED record Report an error
Ripisrl	Italy	DYMOV® ORTHO INSOLE3 refs	I MDR	info@ripisrl.it EUDAMED record Report an error
Ruian Sunnyworld International Trade FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	PENLIGHT SW-PL01,SW-PL07,SW-PL16, SW-45,SWPL48,SW-PL49, SW-PL783 refs	I MDR	rashengweide@outlook.com EUDAMED record Report an error
Sapi Med FDA	Italy	Adaptor A.03513 refs	I MDR	Website EUDAMED record Report an error
Schiller Healthcare India EU representative : SCHILLER MEDICAL (France)	India	MUSTANG V2	I MDR	Website EUDAMED record Report an error
Schyns	Germany	Q1003 refs	IIb MDR	Website info@schyns.de EUDAMED record Report an error
Sedatelec FDA	France	Premio 40 Light	I MDR	Website EUDAMED record Report an error
Sefam	France	PolyLink	I MDR	Website regulatoryaffairs@sefam-medical.com EUDAMED record Report an error
Shanghai Flower Medical Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	FL700/700,+C2:C37 FL700/500, FL500/500, FL700/ FL500, FZ700/700, FZ700/500, FZ500/500, FZ700 FZ500, FL720/720, FL720/520, FL520/520, FL520 FL720, FLSX6+6FLK5+3, FLK5, FLk3, FLXYC3/3 FLXYC3, FKWY-L4, FKWY-H4, FKWY-L5, FKWY-H5 FLM1700, etc2 refs	I MDR	sales007@flower-med.com EUDAMED record Report an error
Shanghai No.2 Medical College Duhang Medical Equipment Factory EU representative : SUNGO Europe B.V. (Netherlands)	China	DL-LED,DL-LED-A6/6(X),DL-LED-A6/5(X),DL-LED-A5/5(X),DL-LED-A6(X),DL-LED-A5(X),DL-LED-B6(X),DL-LED-B5(X), DL-LED-A6/6(L1), DL-LED-A6/5(L1), DL-LED-A5/5(L1), etc3 refs	I MDR	EUDAMED record Report an error
Sibel Sau	Spain	Adhesivos de sujeción	I MDR	Website EUDAMED record Report an error
Sleepiz FDA EU representative : MED-RAS GmbH Regulatory Affairs Service (Germany)	Switzerland	Sleepiz One+ Connect	IIa MDR	Website info@sleepiz.com EUDAMED record Report an error
Softlinkmed EU representative : Eunitor GmbH (Germany)	China	LED light source IS200002 refs	I MDR	marketing@softlinkmed.com EUDAMED record Report an error
Specore Med-Tech EU representative : Share info GmbH (Germany)	China	LED Dental Lamp LDL-KY013 refs	I MDR	EUDAMED record Report an error
Spectrum Medical FDA EU representative : Spectrum Medical S.r.l. (Italy)	United Kingdom (ex Northern Ireland)	Quantum Light - SAP12 refs	I MDR	Website regulatory@spectrummedical.com EUDAMED record Report an error
Spes Medica FDA	Italy	VLED3 refs	I MDR	Website info@spesmedica.com EUDAMED record Report an error
SternMed	Germany	SternMed GmbH Lumax 25 / Lumax 15 / Lumax 5 / Lumax 3/ Lumax 3M / Lumax 1M3 refs	I MDR	Website info@sternmed.de EUDAMED record Report an error
Sucesores De Manuel García	Spain	PEDALIER DE EJERCICIOS DE REHABILITACIÓN / REHABILITATION PEDAL EXERCISER	I MDR	Website EUDAMED record Report an error
Sunoptictech FDA EU representative : AJW Technology Consulting GmbH (Germany)	United States	Fiber Optic Cables and Accessories (Adapters)	I MDR	EUDAMED record Report an error
Surtex Instruments FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United Kingdom (ex Northern Ireland)	Clar Head Light Complete With Transformer Power Source 6 Volts 50554459DIAGNOSIA1290046F3 refs	I MDR	Website info@surtex-instruments.co.uk EUDAMED record Report an error
Taktvoll FDA EU representative : MedPath GmbH (Germany)	China	Medical Examination Light LED-5000	I MDR	Website EUDAMED record Report an error
Techmed	Poland	Kaseton elektryczno-gazowy ISA 90002 refs	IIb MDR	EUDAMED record Report an error
Toruscare	Poland	Alnno XL11 Medical pendant3 refs	I MDR	EUDAMED record Report an error
Tur-Med Hastane Malz San Tic Şti	Türkiye	EXAMINATION LAMP TM-F 6013	I MDR	Website info@turmedonline.com EUDAMED record Report an error
TZ Medical FDA EU representative : CEpartner4U (Netherlands)	United States	TruBrite	I MDR	Website info@tzmedical.com EUDAMED record Report an error
Vivo Surgical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Singapore	KLARO In Vivo Surgical Lighting 555-01-0193/42	IIa 93/42	Website regulatory@vivo-surgical.com EUDAMED record Report an error
Vorotek FDA EU representative : Emergo Europe B.V. (Netherlands)	Australia	VorOtek L Scope HeadBand Model with 42cm Working Distance3 refs	I MDR	Website office@vorotek.com.au EUDAMED record Report an error
Warrenwell EU representative : MedPath GmbH (Germany)	China	WARRENWELL Surgical light9 refs	I MDR	EUDAMED record Report an error
Weihai Wego Qiquan Medical Equipment EU representative : Everbiz GmbH (Germany)	China	Medical Bridge/Ceiling Pendant WG-DTQ, WG-DTQS, WG-DTA, WG-DTC, WG-DTEA , WG-DTEC, WG-DTM, WG-DTAO, WG-DTI, WG-DTPW, WG-DTHS3 refs	I MDR	EUDAMED record Report an error
Wieth Medical Systems e.K	Germany	CURVCONTROL DeLight 5.03 refs	I MDR	Website EUDAMED record Report an error
Zeiss FDA	Germany	Headlamp	I MDR	Website EUDAMED record Report an error
Zumax Medical FDA EU representative : MedNet EC-REP GmbH (Germany)	China	EL70102 refs	I MDR	sales@zumaxmedical.com EUDAMED record Report an error
Özden Tip Tibbi̇ Ci̇haz Ve Malzemeler Gida Teksti̇l Ti̇c Şti̇	Türkiye	AGREMON3 refs	I MDR	info@ozdentip.com EUDAMED record Report an error
Ascent Meditech EU representative : Mars Medical (Germany) No model still on the market	India	Flamingo Exercise Cycle OC-21772 refs (no longer marketed)	I MDR	Website regulatory@ascentmeditech.com EUDAMED record Report an error
Imaginecare No model still on the market	Sweden	ImagineCare93/42 (no longer marketed)	I 93/42	Website regulatory@imaginecare.com 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) 349

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
Osstem Implant Co., Ltd. Present in Europe in other categories	South Korea	122 Taper Drill Taper Drill OneGuide Taper Drill Bone Compaction Drill Twist Drill 123 Twist Drill	registered
Neobiotech. co., ltd	South Korea	Neobiotech Implant System	registered
DIO Corporation	South Korea	DIOnavi. Straight Drill DIO Straight Drill FTN Tapered Drill DIOnavi. Initial Drill DIOnavi. Abutment Profile Drill DIOnavi. Profile Drill	registered
Ossvis Co., Ltd.	South Korea	Step Drill Twist Drill Round Drill Point Drill Guide Full Step Drill Trimming Drill	registered
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)	–	Magic Drill Magic Tap Drill Magic Guide Pin Magic Depth Drill Surgical Guide Final Drill Magic Guide Pin SET	registered
Izenimplant Co., Ltd.	South Korea	ZENEX Guide Twist Drill Step Drill Taper Drill ZENEX Guide Initial Drill Twist Drill Bone Profiler	registered
Jota AG	Switzerland	JOTA C246.FG.012	registered
EDENTA ETABLISSEMENT Present in Europe in other categories	Liechtenstein	EDENTA	registered
KEYSTONE DENTAL, INC.	United States	Restore Prima Genesis Stage-1 Genesis ACTIVE Prima Plus	registered
ARUM DENTISTRY Co., Ltd. Present in Europe in other categories	South Korea	Step Drill Final Drill Guide Step Drill Guide Final Drill Guide Initial Drill Sinus Crestal Drill	registered
Truabutment Korea Co.,Ltd	South Korea	Final Drill Initial Drill Pilot Drill TruGUIDE Twist Drill Surgical Drill Point Drill	registered
Shinhung MST Co., Ltd.	South Korea	Surgical Kit ever GUIDE KIT S-Guide Kit evertis Sinus Kit Short Drill Kit	registered
Cowellmedi Co.,Ltd Present in Europe in other categories	South Korea	Dental Surgical Drill Countersink	registered
Surgikor, LLC	United States	Final Drill Straight Drill with Stopper without Irrigation Straight Twist Drill Counter Sink Drill Lance Drill Pilot Drill	registered
SNUCONE Co.,LTD. Present in Europe in other categories	South Korea	GUIDE TWIST STOPPER DRILL STOPPER TWIST DRILL GUIDE TWIST STOPPER DRILL (Narrow) TWIST DRILL GUIDE TWIST DRILL STOPPER PILOT DRILL	registered
United Dental Changzhou	China	Bondent	registered
Ritter Implants GmbH & Co. KG Present in Europe in other categories	United States	Ritter Implants Dental System	registered
POINTIMPLANT Co., Ltd. Present in Europe in other categories	South Korea	Final Drill Initial Drill Cortical Drill Bone Profile Drill Fixture Tap Drill Sidecut Drill	registered
LOOCID LLC	–	Loocid BCP	registered
Chengdu Besmile Medical Technology Co., Ltd. Present in Europe in other categories	China	Drill Driver	registered
BIO CONCEPT Co., Ltd.	China	Trephine Drill Bone Profiler SR Drill Mini Screw Removal Drill BV Guide Drill,Φ3.5mm/Φ5.7mm,L8.5mm Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,Guided	registered
PALTOP ADVANCED DENTAL SOLUTIONS LTD Present in Europe in other categories	United States	Paltop	registered
MIG TOOLS INDUSTRIA E COMERCIO LTDA	–	Migtools	registered
WARANTEC.Co.,Ltd Present in Europe in other categories	South Korea	Step Drill Tap Drill Bone Collecting Drill Final Drill Trephine Drill Sinus Drill	registered
RIVERPOINT MEDICAL, LLC	United States	MedLED Chrome MedLED Spectra MedLED MaxLite Elite MedLED Face Shield MedLED Classic	registered
Peter Brasseler Holdings, LLC	United States	Brasseler USA	registered
NORIS MEDICAL LTD	Israel	EZguide Stop Drill Dental Drill Diamond Burr Drill Stopper Fixation screw Countersink Drill	registered
Bioplate, Inc.	United States	Bioplate®	registered
ZimVie US Corp LLC	United States	Driva™ Tapered Screw-Vent® Driva® Spline® Pilot Eztetic®	registered
OCO BIOMEDICAL INC	United States	Drill Stop Guided Surgery Final Drill Pilot Drill Osteotomy Former Drill Stop for Pilot Drill CRESTAL FORMER	registered
ACE SURGICAL SUPPLY CO., INC.	United States	ACE TRI-CAM Dental Implant System miniMark Dental Implant System TRICAM Dental Implant System	registered
Diaswiss SA Present in Europe in other categories	Switzerland	Peeso 32mm 110, pu: 6 pcs rootEX plug 2,0 mm pu: 6 pcs rootEX drill 0,8 mm, pu: 6 pcs Gates 25mm 090 rootEX drill short shank 1,8 mm, pu: 6 Peeso 32 mm 070, pu: 6 pcs	registered
Dentatus AB	Sweden	Helix Conical Reamers Helix Classic Reamers Classic Standard Reamers Surtex Conical / Tapered Reamers Luscent	registered
Biotem Co., ltd	South Korea	Biotem Bone Pen Drill	registered
DENTIN IMPLANTS TECHNOLOGIES LTD	Israel	DRILL BIT CONICAL DRILL TREPHINE DRILL DRILL SET COUNTERSINK DRILL MARKING DRILL	registered
COLTENE/WHALEDENT INC Present in Europe in other categories	United States	ParaPost ParaPost XT Kodex ParaPost XP ParaPost Taper Lux Max	registered
DiaDent Group International	South Korea	DIA-X FILE GATE DRILLS PEESO REAMERS DIA-KONDENSOR	registered
BLACK & BLACK SURGICAL, INC. Present in Europe in other categories	United States	Black & Black Surgical Black & Black Surgical, Inc.	registered
SONTEC INSTRUMENTS, INC.	United States	LOUPE CARRIER HIGH RESOLUTION BINOCULAR LOUPES SET LED LOUPE LIGHT XHL XENON HALOGEN BULB OPTIVISOR BINOCULAR MAGNIFIER MINI 3000 COMBINATION SET	registered
MANI, INC.	–	MANI PEESO REAMERS MANI GATES DRILLS	registered
MARINA MEDICAL INSTRUMENTS, INC.	United States	Marina Medical	registered
NTI - Kahla GmbH Rotary Dental Instruments	Germany	NTI	registered
NOGA MEDICAL PRODUCTS LTD	Israel	Drill ø5.50mm External Irrigation Drill ø2.50mm External Irrigation Short Drill ø2.50mm External Irrigation Step Drills with Integral Stopper Dia.2.4 L10mm Step drill ø2.80/2.3mm Short Drill ø4.50mm External Irrigation	registered
TULSA DENTAL PRODUCTS LLC	United States	Hedstroem Rotary File WaveOne Rotary File	K954790 (1996)
Power Dental U.S.A. Inc.	United States	Power Dental USA	registered
RHEIN 83 SRL	Italy	INVASIVE ACCESSORIES AND INSTRUMENTS	registered
ESSENTIAL DENTAL SYSTEMS, INC.	United States	Essential Countersink Drill EZ-Fill Bi-Directional Spiral Essential Primary Reamer Essential Gates Glidden Drills Essential Secondary Drill Flexi-Post Fiber & Flexi-Flange Fiber	registered
Suncoast Dental, Inc	United States	Brasseler Brassler Universal Screw Removal Kit	registered
Jedmed Instrument Co.	United States	JEDMED	registered
HENRY SCHEIN, INC. Present in Europe in other categories	United States	Henry Schein	registered
Megagen Implant Co. Ltd Present in Europe in other categories	South Korea	Diamond Drill Root Membrane Kit Shaping Drill Lindermann Drill Finishing Drill	registered
IQ DENTAL SUPPLY LLC	–	IQ Dental	registered
SCOTT'S DENTAL SUPPLY L.L.C.	–	SCOTT'S SELECT GATES DRILLS 6/pk 32mm # 4 SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 3 SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 4 SCOTT'S SELECT PEESO REAMERS 6/pk 32mm # 1-6 ASST SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 1-6 ASST SCOTT'S SELECT GATES DRILLS 6/pk 32mm # 2	registered
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION	–	Trephine burrs ø3x4mm Countersink 5mm/6mm Conical Drill for implant ø6mm Trephine burrs ø4x5mm Drill stopper ø2.0mm L 13 Drill ø3.80mm External Irrigation	registered
UNIQA DENTAL LTD	Israel	–	registered
Achimhai Medical Corporation	–	Nexplant	registered
DENTACK IMPLANTS LTD	–	Twist Drill D=3.20mm,L=7.5mm Twist Drill D=2.80mm,L=6.5mm Twist Drill D=2.80mm,L=5.5mm Twist Drill D=3.80mm,L=8.5mm Twist Drill D=3.65mm,L=8.5mm Twist Drill D=3.20mm,L=5.5mm	registered
OVERFIBERS SRL	Italy	Endontic Drill # 2 Polygon Drill # 1 Endontic Drill # 1 Cylindrical Drill # 1,0 Conical Drill # Small Cylindrical Drill # 1,6	registered
RZ-Medizintechnik GmbH Present in Europe in other categories	Germany	RZ Medizintechnik GmbH Guiding Wire Guide Wire	registered
Ilumi Sciences, Inc.	United States	iLumi	registered
FKG Dentaire Sàrl	Switzerland	PEESO GATES XS GATES	registered
BR Surgical, LLC	–	BR Surgical, LLC	registered
SWEDEN & MARTINA SPA	Italy	DIAMOND BUR PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. PREPARATION DRILLS KIT FOR B.O.P.T.	registered
E. Hahnenkratt GmbH Present in Europe in other categories	Germany	Hahnenkratt	registered
RECHERCHES TECHNIQUES DENTAIRES	–	D.T. LIGHT-POST ILLUSION X-RO INTROKIT MACRO-LOCK FINISHING DRILL 5 MACRO-LOCK STARTER DRILL 1 D.T. LIGHT-POST FINISHING DRILL 1 MACRO-LOCK FINISHING DRILL 3 D.T. LIGHT-POST FINISHING DRILL 3	registered
Young Innovations, Inc.	United States	Johnson-Promident Defend	registered
DENTECH CORPORATION	United States	DENTECH	registered
Gebr. Brasseler GmbH & Co. KG	Germany	KOMET Intraoral dental drill for root posts	registered
Neoss AB	Sweden	Neoss Implant System	registered
Produits dentaires S.A.	Switzerland	PEESO REAMERS RA, N°2 PEESO REAMERS RA, N°3 Drill-A-Post - N°2 PEESO REAMERS RA, N°6 Drill-A-Post - N°1 Drill-A-Post - N°1 - Rack of 6 pieces	registered
TAIYO CORPORATION Present in Europe in other categories	–	OPELAIII Protected Special Package OPELAIII Standard Package OPELAIII COOLMAX® Comfort Inner Pads OPELAIII calibration kit OPELAIII Dedicated AC Adapter OPELAIII Main Unit	registered
BIOLOREN SRL	Italy	VIVID POST DRILL VIVID POST WHITE VIVID POST TRANSLUCENT	registered
Dental Health Products Inc	–	Health-Tec/DHP Gates Glidden Drills	registered
The Atlanta Dental Supply Company	–	Advance Dental Products	registered
Med Saver, Inc.	–	MSI Precision Specialty Instruments	registered
SAFCO DENTAL SUPPLY CO.	United States	Safco Gates Glidden Drills	registered
PREMIER DENTAL PRODUCTS COMPANY	United States	Premier GATES Premier PEESO drills	registered
Directa AB	Sweden	Sendoline	registered
Medical Illumination International Inc.	United States	IsoLED Plus+ LED HL IsoLED Mini LED HL IsoLED II LED HL Magnum LED HL	registered
Dentscare Ltda	Brazil	Whitepost System	registered
SPORT MEDICAL TECHNOLOGY INC. Present in Europe in other categories	United States	Gait Trainer 3 Reactive Step Trainer 115V	registered
US ENDODONTICS, LLC	United States	EdgeGates™	registered
NOVO SURGICAL, INC.	–	Novo Surgical Inc. Novo Surgical	registered
Avalign Technologies, Inc.	United States	Millennium Avalign	registered
OSUNG MND Co., Ltd.	South Korea	OSUNG MND	registered
PRACTICON, INC.	United States	TTL Easy Size 2.5X Loupes Red TTL Easy Size 3.0X Loupes Red TTL Easy Size 2.5X Loupes Silver TTL Easy Size 3.0X Loupes Silver TTL Easy Size 2.5X Loupes Black TTL Easy Size 3.0X Loupes Black	registered
Alphadent NV	–	CEKA & PRECI-LINE ATTACHMENTS	registered
BENCO DENTAL SUPPLY CO.	–	BENCO	registered
DARBY DENTAL SUPPLY, LLC	–	Darby Dental Supply, LLC	registered
PATTERSON DENTAL SUPPLY, INC.	United States	Patterson	registered
VOCO GmbH Present in Europe in other categories	Germany	Rebilda Post	registered
COHO BIOMEDICAL TECHNOLOGY CO., LTD.	–	Zibone	registered
GSOURCE LLC	United States	gSource	registered
Preat Corporation	–	Preat Preat Implant Prosthetics O-Ring Perma Ret	registered
ELMED INCORPORATED	United States	ELMED ELMED INCORPORATED	registered
FAIRFAX MEDICAL PRODUCTS LIMITED Present in Europe in other categories	United Kingdom	Stabilok drill Stabident	registered
MORIA SA Present in Europe in other categories	France	MORIA	registered
STERIS Corporation Present in Europe in other categories	United States	V. Mueller	registered
UNIVERSAL SHAPERS LLC	–	Universal Shapers	registered
ABRASIVE TECHNOLOGY, INC.	United States	Two Striper	registered

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