Instruments for functional explorations and therapeutic interventions

Neurology and neurosurgery instruments

EMDN code Z1210

141 manufacturers, 1,252 models including 1,165 on the market, 30 countries

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

Manufacturers registered in Europe (EUDAMED) 141

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
Magstim FDA EU representative : MPS Medical Product Service GmbH (Germany) and 1 other	United Kingdom (ex Northern Ireland), United States	128 Channel Geodesic EEG System (GES) 400 Portable 140128293/42 130303293/42 130306493/42 130312893/42 130425693/42 245 others 140032293/42 140032393/42 140064393/42 140256293/42 142000193/42 147301093/42 147301193/42 147301293/42 153000093/42 153000193/42 197522093/42 197522193/42 197522293/42 256 Channel Geodesic EEG System (GES) 400 Desktop 140256393/42 310200893/42 310200993/42 395701693/42 395701793/42 395701893/42 395702793/42 460078693/42 460078793/42 460141893/42 460171893/42 460284293/42 460399093/42 460399193/42 460815093/42 460818093/42 460927393/42 460975493/42 460975793/42 460975893/42 460978693/42 473000093/42 473001093/42 473002093/42 473003093/42 473004093/42 473005093/42 473010093/42 473011093/42 473012093/42 473013093/42 473014093/42 473015093/42 473016093/42 473017093/42 473018093/42 473019093/42 473020093/42 473100093/42 473101093/42 473102093/42 473103093/42 473104093/42 473105093/42 473110093/42 473111093/42 473112093/42 473113093/42 473114093/42 473115093/42 473116093/42 473117093/42 473118093/42 473119093/42 473120093/42 473204093/42 473205093/42 473210093/42 473211093/42 473212093/42 473213093/42 473214093/42 473215093/42 473218093/42 473219093/42 473220093/42 473300093/42 473301093/42 473302093/42 473303093/42 473304093/42 474300093/42 474300193/42 474301093/42 474301193/42 474302093/42 474302193/42 474303093/42 474303193/42 474304093/42 474304193/42 475000093/42 475000193/42 475001093/42 475001193/42 475002093/42 475002193/42 475003093/42 475003193/42 475004093/42 475004193/42 475005093/42 475005193/42 475011093/42 475012093/42 475013093/42 475014093/42 475015093/42 475016093/42 475017093/42 475100093/42 475100193/42 475101093/42 475101193/42 475102093/42 475102193/42 475103093/42 475103193/42 475104093/42 475104193/42 475105093/42 475105193/42 475110093/42 475111093/42 475112093/42 475113093/42 475114093/42 475115093/42 475116093/42 475117093/42 475200093/42 475200193/42 475201093/42 475201193/42 475202093/42 475202193/42 475203093/42 475203193/42 475204093/42 475204193/42 475205093/42 475205193/42 475210093/42 475211093/42 475212093/42 475213093/42 475214093/42 475215093/42 475216093/42 475217093/42 479000193/42 479001193/42 479002193/42 479003193/42 479100193/42 479101193/42 479102193/42 479103193/42 479200193/42 479201193/42 479202193/42 479203193/42 479204193/42 479300193/42 479301193/42 479302193/42 479303193/42 479304193/42 615004493/42 615004593/42 615305793/42 615305893/42 615422293/42 615633193/42 615636393/42 615636693/42 615975893/42 90mm Remote Control Coil 3192-0093/42 D70mm MT Remote Coil 4949-0093/42 D70mm Remote Control Coil 3190-0093/42 GES 400 Series 128 Channel Geodesic EEG System (GES) 400 Desktop93/42 HCGSN 130 473200093/42 HCGSN 130 473201093/42 HCGSN 130 473202093/42 HCGSN 130 473203093/42 HCGSN 130 473217093/42 HCGSN 130 LTM 473003193/42 HCGSN 130 LTM 473004193/42 HCGSN 130 LTM 473005193/42 HCGSN 130 LTM 473100193/42 HCGSN 130 LTM 473101193/42 HCGSN 130 LTM 473102193/42 HCGSN 130 LTM 473103193/42 HCGSN 130 LTM 473104193/42 HCGSN 130 LTM 473105193/42 HCGSN 130 LTM 473200193/42 HCGSN 130 LTM 473201193/42 HCGSN 130 LTM 473203193/42 HCGSN 130 LTM: 128 ch Adult Medium 56-58 cm 473202193/42 HCGSN 130 LTM: 128 ch Pediatric Large 51-54 cm 473204193/42 HCGSN 130 LTM: 128 ch Pediatric Small 47-51 cm 473205193/42 HCGSN 130 LTM: 256 ch Adult Large 58-61 cm 473301193/42 HCGSN 130 LTM: 256 ch Adult Medium 56-58 473302193/42 HCGSN 130 LTM: 256 ch Adult Small 54-56 cm 473303193/42 HCGSN 130 LTM: 256 ch Adult XL 61-64 cm 4733001Y93/42 HCGSN 130 LTM: 256 ch Pediatric Large 51-54 473304193/42 HCGSN 130 LTM: 32 Channel Adult Large 58-61 cm 473001193/42 HCGSN 130 LTM: 32ch Adult XL 61- 64cm 473000193/42 HCGSN 130: 128 ch Infant 36-37 cm 473216093/42 Horizion MT Remote Coil 4990-0093/42 Horizon 3.0 Inspire Mainframe3 refs Horizon Air Film Coil 4980-0093/42 Horizon E-z Cool Coil (Naz) 5367-0093/42 Horizon E-z Cool Coil 4999-0093/42 Horizon Power Supply Unit (PSU) 4806-0093/42 Magstim 110m Double Cone Coil 4610-0093/42 Magstim 200² UI Controller 3020-0093/42 Magstim 200² Stimulator 3010-0093/42 Magstim BiStim² Connecting Module 3330-0093/42 Magstim BiStim² Controller 3021-0093/42 Magstim D40 Alpha Flat Coil (Coated) 4180-0093/42 Magstim D40a Branding Iron (Coated) Coil 4179-0093/42 Magstim D50 Alpha Flat Coil (Coated) 4186-0093/42 Magstim D50a Branding Iron (Coated) Coil 4185-0093/42 Magstim D60 Alpha Flat Coil (Coated) 4190-0093/42 Magstim D60a Branding Iron (Coated) Coil 4189-0093/42 Magstim D70 Alpha Coil 4150-0093/42 Magstim D70a Branding Iron (Coated) Coil 4510-0093/42 Magstim D70² Coil 4102-0093/42 Magstim Dual Power Supply Module 3014-0093/42 Magstim Plus1 Module 4040-0093/42 Magstim Rapid2 MEP Pod 3526-0093/42 Magstim Rapid2 UI Controller 3022-0093/42 Magstim Single Power Supply Module 3013-0093/42 Mute Sensor 1020-0093/42 (no longer marketed) Neourosign V4 Mute Sensor 4225-0093/42 (no longer marketed) Neurosign 100 Unit 9883-0193/42 (no longer marketed) Neurosign V4 IntraOperative Nerve Monitor 4230-0093/42 (no longer marketed) Neurosign V4 Pre-Amplifier Pod - 4 Channel 4444-0093/42 (no longer marketed) Neurosign V4 Pre-Amplifier Pod - 8 Channel 4448-0093/42 (no longer marketed) Neurosign V4 Stimulator Pod 4440-0093/42 (no longer marketed) Stimulator Pod 9967-0093/42 (no longer marketed)	IIa, IIb MDR, 93/42	Website regulatorymagstim@welcony.com EUDAMED record Report an error
Friendshipmedical FDA EU representative : Friendship Europe ApS (Denmark)	China	Cadwell 302294-000-02093/42 Cadwell 302294-000-04093/42 Cadwell 302294-000-08093/42 Cadwell 302294-000-12093/42 Cadwell 302353-000-04093/42 217 others Cadwell 302353-000-06093/42 Cadwell 302353-000-08093/42 Cadwell 302353-000-10093/42 CadWell 302354-000-06093/42 CadWell 302355-000-06093/42 CadWell 302356-000-06093/42 Cadwell 302357-00093/42 Cadwell 302358-00093/42 CadWell 302359-000-06093/42 CadWell 302360-000-04893/42 CadWell 302360-000-06093/42 CadWell 302360-000-08093/42 CadWell 302360-000-10093/42 Cadwell 302400-00093/42 Cadwell 302401-00093/42 Cadwell 302402-00093/42 Cadwell 302403-00093/42 Cadwell 302404-000-09093/42 Cadwell 302404-000-16093/42 Cadwell 302404-000-20093/42 Cadwell 302405-00093/42 Cadwell 302420-00093/42 Cadwell 302421-00093/42 Cadwell 302422-00093/42 Cadwell 302423-00093/42 Cadwell 302424-00093/42 Cadwell 302425-00093/42 Cadwell 302426-00093/42 Cadwell 302427-00093/42 Cadwell 302427-000-20093/42 Cadwell 302428-00093/42 Cadwell 302429-00093/42 Cadwell 302430-000-09093/42 Cadwell 302430-000-20093/42 Cadwell 302431-00093/42 Cadwell 302820-000-04093/42 Cadwell 302820-000-06093/42 Cadwell 302820-000-08093/42 Cadwell 302820-000-10093/42 Cadwell 302821-000-06093/42 Cadwell 302822-000-04093/42 Cadwell 302822-000-06093/42 Cadwell 302822-000-08093/42 Cadwell 302822-000-10093/42 Cadwell 302823-000-06093/42 Cadwell 302824-000-06093/42 Cadwell 302825-000-04093/42 Cadwell 302825-000-06093/42 CadWell 302825-000-08093/42 CadWell 302825-000-10093/42 CadWell 302826-000-06093/42 CadWell 302827-000-06093/42 Cadwell 302850-000-08093/42 CadWell 302851-000-06093/42 CadWell 302851-000-10093/42 CadWell 302852-000-06093/42 CadWell 302852-000-10093/42 Cadwell 302853-000-06093/42 Cadwell 302853-000-10093/42 Cadwell 302854-000-06093/42 Cadwell 302854-000-10093/42 Friendship Medical3 refs Friendship Medical CCN3 refs Friendship Medical CCS3 refs Friendship Medical CMN3 refs Friendship Medical DECL3 refs Friendship Medical DECL101500-PC93/42 Friendship Medical DECL101500-SC93/42 Friendship Medical DECL101500-TF93/42 Friendship Medical DECL102500-PC93/42 Friendship Medical DEG3 refs Friendship Medical DEG102500-PC93/42 Friendship Medical DES101500-PC93/42 Friendship Medical DES101500-TF93/42 Friendship Medical DES102500-SC93/42 Friendship Medical DES102500-TF93/42 Friendship Medical DRE-T Friendship Medical DRE300093/42 Friendship Medical EW-P1; EW-P2; EW-P1/P23 refs Friendship Medical NE-D1-1000/12/0.493/42 Friendship Medical NE-D1-1500/12/0.493/42 Friendship Medical NE-D1-2000/12/0.493/42 Friendship Medical NE-D1-2500/12/0.493/42 Friendship Medical NE-P-1500/13/0.493/42 Friendship Medical NE-P-1500/17/0.4593/42 Friendship Medical NE-P-1500/23/0.493/42 Friendship Medical NE-P-1500/7/0.493/42 Friendship Medical NE-P-2000/13/0.493/42 Friendship Medical NE-P-2500/23/0.493/42 Friendship Medical NE-S, NE-SS3 refs Friendship Medical NE-S-1500/13/0.493/42 Friendship Medical NE-S-1500/23/0.493/42 Friendship Medical NE-S-1500/6/0.493/42 Friendship Medical NE-S-1500/7/0.3593/42 Friendship Medical NE-S-1500/7/0.493/42 Friendship Medical NE-S-2000/16/0.493/42 Friendship Medical NE-S-2500/13/0.493/42 Friendship Medical NE-S-2500/19/0.493/42 Friendship Medical NE-S-2500/7/0.493/42 Friendship Medical NE-SS-100/13/0.493/42 Friendship Medical NE-SSB Friendship Medical NE-SSB-100/13/0.493/42 Friendship Medical NE-SSB-1500/20/0.4593/42 Friendship Medical NE-T, NE-P3 refs Friendship Medical NE-T-1500/16/0.493/42 Friendship Medical NE-T-1500/20/0.3593/42 Friendship Medical NE-T-1500/7/0.3593/42 Friendship Medical NE-T-2000/15/0.493/42 Friendship Medical NE-T-2000/16/0.493/42 Friendship Medical NE-T-2000/19/0.3593/42 Friendship Medical NE-T-2000/19/0.493/42 Friendship Medical NE-T-2000/25/0.493/42 Friendship Medical NE-T-2500/13/0.493/42 Friendship Medical NE-T-2500/21/0.493/42 Friendship Medical NE-T-2500/23/0.493/42 Friendship Medical NE-T-2500/25/0.493/42 Friendship Medical NE-T-2500/7/0.493/42 Friendship Medical NE-T3-1000/20/0.393/42 Friendship Medical NE-T3-500/13/0.493/42 Friendship Medical NE-T5, NE-P5 Friendship Medical NE-T6, NE-P62 refs Friendship Medical NE-T6-1500/13/0.493/42 Friendship Medical NE-T6-2000/13/0.493/42 Friendship Medical NEBN253093/42 Friendship Medical NEBN253593/42 Friendship Medical NEBN304093/42 Friendship Medical NEBN384593/42 Friendship Medical NEBN505093/42 Friendship Medical NEBN756593/42 Friendship Medical NEC253593/42 Friendship Medical NEC304093/42 Friendship Medical NEC354093/42 Friendship Medical NEC384593/42 Friendship Medical NEC505093/42 Friendship Medical NEC756593/42 Friendship Medical NEM202593/42 Friendship Medical NEM253093/42 Friendship Medical NEM253593/42 Friendship Medical NEM304093/42 Friendship Medical NEM384593/42 Friendship Medical NEM505093/42 Friendship Medical NEM756593/42 Friendship Medical NES-D13 refs Friendship Medical NES-D23 refs Friendship Medical NES-D2-1000/0.693/42 Friendship Medical NES-D2-1200/0.693/42 Friendship Medical NES-D2-2000/0.693/42 Friendship Medical NES-D2-2500/0.693/42 Friendship Medical PNB3 refs Friendship Medical PNBB0.8×2/9093/42 Friendship Medical PNC Friendship Medical PNCB2 refs Friendship Medical PNG3 refs Friendship Medical PNG2.3/16093/42 Friendship Medical PNG2.3/20093/42 Friendship Medical PNG2.3/22093/42 Friendship Medical PNG2.3/29593/42 Friendship Medical PNGB2.3/20093/42 Friendship Medical PNH6 refs Friendship Medical PNH1.2/80×3×100˚93/42 Friendship Medical PNH1.2/80×3×180˚93/42 Friendship Medical PNHG, PNYG Friendship Medical PNHG2.0/30×293/42 Friendship Medical PNHG2.0/80×293/42 Friendship Medical PNM3 refs Friendship Medical PNM0.8/20093/42 Friendship Medical PNN0.25/1393/42 Friendship Medical PNN0.3/1393/42 Friendship Medical PNN0.4/1393/42 Friendship Medical PNT3 refs Friendship Medical PNT0.8/9093/42 Friendship Medical SEAg-C3 refs Friendship Medical SEAg-C-0.7/100/14×2493/42 Friendship Medical SEAg-C-0.7/100/22×3093/42 Friendship Medical SEAg-C-1.5/1500/22X3093/42 Friendship Medical SEAg-J2 refs Friendship Medical SEAg-J-23×3493/42 Friendship Medical SEAg-P-1500/20×2793/42 Friendship Medical SEAg-P-2500/20×2793/42 Friendship Medical SEAg-S3 refs Friendship Medical SEAg-S-0.7/100/15×2093/42 Friendship Medical SEAg-S-0.7/200/15×2093/42 Friendship Medical SEAg-S-0.7/200/20×2793/42 Friendship Medical SEAg-S-100/1093/42 Friendship Medical SEAg-S-1000/2093/42 Friendship Medical SEAg-S-1000/35×5093/42 Friendship Medical SEAg-S-1500/15×2093/42 Friendship Medical SEAg-S-1500/2093/42 Friendship Medical SEAg-S-1500/20×2793/42 Friendship Medical SEAg-S-2000/2093/42 Friendship Medical SEAg-S-2000/35×5093/42 Friendship Medical SEAg-S-2500/15×2093/42 Friendship Medical SEAg-S-2500/20×2793/42 Friendship Medical SEAg-S-2500/35×5093/42 Friendship Medical SEAg-T-1500/2093/42 Friendship Medical SEAg-T-1500/20×2793/42 Friendship Medical SEAg-T-2000/15×2093/42 Friendship Medical SEAg-T-2500/10x1093/42 Friendship Medical SEAg-T-2500/20×2793/42 Friendship Medical SEAg-T; SEAg-P3 refs Friendship Medical SEC-5P/2X0.73 refs Friendship Medical SEC-5P/3C3 refs Friendship Medical SEC-5P/3X0.73 refs Friendship Medical SN1235/0.7593/42 Friendship Medical SN1235/1.093/42 Friendship Medical SN153593/42 Friendship Medical SN156593/42 Friendship Medical SN204093/42 Friendship Medical SN304093/42 Friendship Medical SN306593/42 Friendship Medical SN506593/42 Friendship Medical SNF1340/1.093/42 Friendship Medical SNW1535/1.093/42 Friendship Medical SNW1835/1.093/42 Natus 01750693/42 Natus 01750893/42 Natus 01751293/42	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Taijieweiye EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	Perdenser TJCST0201-2D93/42 Perdenser TJCST0201-3D93/42 Perdenser TJCST0202-2D93/42 Perdenser TJCST0202-3D93/42 Perdenser TJCST0203-2D93/42 109 others Perdenser TJCST0203-3D93/42 Perdenser TJCST0204-2D93/42 Perdenser TJCST0204-3D93/42 Perdenser TJCST0206-2D93/42 Perdenser TJCST0206-3D93/42 Perdenser TJCST0208-2D93/42 Perdenser TJCST0208-3D93/42 Perdenser TJCST0304-2D93/42 Perdenser TJCST0304-3D93/42 Perdenser TJCST0306-2D93/42 Perdenser TJCST0306-3D93/42 Perdenser TJCST0308-2D93/42 Perdenser TJCST0308-3D93/42 Perdenser TJCST0310-2D93/42 Perdenser TJCST0310-3D93/42 Perdenser TJCST0312-2D93/42 Perdenser TJCST0312-3D93/42 Perdenser TJCST0404-2D93/42 Perdenser TJCST0404-3D93/42 Perdenser TJCST0406-2D93/42 Perdenser TJCST0406-3D93/42 Perdenser TJCST0408-2D93/42 Perdenser TJCST0408-3D93/42 Perdenser TJCST0410-2D93/42 Perdenser TJCST0410-3D93/42 Perdenser TJCST0509-2D93/42 Perdenser TJCST0509-3D93/42 Perdenser TJCST0510-2D93/42 Perdenser TJCST0510-3D93/42 Perdenser TJCST0515-2D93/42 Perdenser TJCST0515-3D93/42 Perdenser TJCST0520-2D93/42 Perdenser TJCST0520-3D93/42 Perdenser TJCST0610-2D93/42 Perdenser TJCST0610-3D93/42 Perdenser TJCST0611-2D93/42 Perdenser TJCST0611-3D93/42 Perdenser TJCST0615-2D93/42 Perdenser TJCST0615-3D93/42 Perdenser TJCST0620-2D93/42 Perdenser TJCST0620-3D93/42 Perdenser TJCST0715-2D93/42 Perdenser TJCST0715-3D93/42 Perdenser TJCST0720-2D93/42 Perdenser TJCST0720-3D93/42 Perdenser TJCST0730-2D93/42 Perdenser TJCST0730-3D93/42 Perdenser TJCST0815-2D93/42 Perdenser TJCST0815-3D93/42 Perdenser TJCST0820-2D93/42 Perdenser TJCST0820-3D93/42 Perdenser TJCST0830-2D93/42 Perdenser TJCST0830-3D93/42 Perdenser TJCST0920-2D93/42 Perdenser TJCST0920-3D93/42 Perdenser TJCST0930-2D93/42 Perdenser TJCST0930-3D93/42 Perdenser TJCST1.502-2D93/42 Perdenser TJCST1.502-3D93/42 Perdenser TJCST1.503-2D93/42 Perdenser TJCST1.503-3D93/42 Perdenser TJCST1.504-2D93/42 Perdenser TJCST1.504-3D93/42 Perdenser TJCST1020-2D93/42 Perdenser TJCST1020-3D93/42 Perdenser TJCST1030-2D93/42 Perdenser TJCST1030-3D93/42 Perdenser TJCST1130-2D93/42 Perdenser TJCST1130-3D93/42 Perdenser TJCST1230-2D93/42 Perdenser TJCST1230-3D93/42 Perdenser TJCST1330-2D93/42 Perdenser TJCST1330-3D93/42 Perdenser TJCST1430-2D93/42 Perdenser TJCST1430-3D93/42 Perdenser TJCST1530-2D93/42 Perdenser TJCST1530-3D93/42 Perdenser TJCST1630-2D93/42 Perdenser TJCST1630-3D93/42 Perdenser TJCST1830-2D93/42 Perdenser TJCST1830-3D93/42 Perdenser TJCST2.502-2D93/42 Perdenser TJCST2.502-3D93/42 Perdenser TJCST2.504-2D93/42 Perdenser TJCST2.504-3D93/42 Perdenser TJCST2.506-2D93/42 Perdenser TJCST2.506-3D93/42 Perdenser TJCST2.508-2D93/42 Perdenser TJCST2.508-3D93/42 Perdenser TJCST2030-2D93/42 Perdenser TJCST2030-3D93/42 Perdenser TJCST3.506-2D93/42 Perdenser TJCST3.506-3D93/42 Perdenser TJCST3.508-2D93/42 Perdenser TJCST3.508-3D93/42 Perdenser TJCST3.510-2D93/42 Perdenser TJCST3.510-3D93/42 Perdenser TJCST3.512-2D93/42 Perdenser TJCST3.512-3D93/42 Perdenser TJCST4.506-2D93/42 Perdenser TJCST4.506-3D93/42 Perdenser TJCST4.508-2D93/42 Perdenser TJCST4.508-3D93/42 Perdenser TJCST4.510-2D93/42 Perdenser TJCST4.510-3D93/42 Perdenser TJCST4.512-2D93/42 Perdenser TJCST4.512-3D93/42 Perdenser TJCST4.515-2D93/42 Perdenser TJCST4.515-3D93/42	III 93/42	EUDAMED record Report an error
Aygün Cerrahi Aletler Sanayi ve Ticaret Anonim Şirketi	Türkiye	20.000 RPM MOTOR HANDPIECE M14-801T93/42 40.000 RPM MOTOR HANDPIECE M14-80093/42 90.000 RPM MOTOR HANDPIECE M14-30293/42 90.000 RPM MOTOR HANDPIECE M16-30293/42 ANGLED ATTACHMENT 100 MM M14-23093/42 53 others ANGLED ATTACHMENT 100 MM M16-23093/42 ANGLED ATTACHMENT 150 MM M14-24093/42 ANGLED ATTACHMENT 150 MM M16-24093/42 ANGLED ATTACHMENT 20 MM M14-20093/42 ANGLED ATTACHMENT 20 MM M16-20093/42 ANGLED ATTACHMENT 210 MM M14-25093/42 ANGLED ATTACHMENT 210 MM M16-25093/42 ANGLED ATTACHMENT 40 MM M14-21093/42 ANGLED ATTACHMENT 40 MM M16-21093/42 ANGLED ATTACHMENT 60 MM M14-22093/42 ANGLED ATTACHMENT 60 MM M16-22093/42 CRANIOTOME ATTACHMENT M14-33093/42 CRANIOTOME ATTACHMENT M16-33093/42 CURVED ATTACHMENT M14-83093/42 CURVED ATTACHMENT M16-83093/42 DRILL LIMIT GUIDE M14-33193/42 DRILL LIMIT GUIDE M16-33193/42 FIXED ADULT GUIDE M14-32293/42 FIXED ADULT GUIDE M14-34193/42 FIXED ADULT GUIDE M16-34193/42 FIXED LAMINECTOMY GUIDE M14-32393/42 FIXED LAMINECTOMY GUIDE M14-34293/42 FIXED LAMINECTOMY GUIDE M16-34293/42 FIXED PEDIATRIC GUIDE M14-32193/42 FIXED PEDIATRIC GUIDE M14-34093/42 FIXED PEDIATRIC GUIDE M16-34093/42 FOOT CONTROL MONO PEDAL M6-05893/42 METAL CUTTER ATTACHMENT M14-77093/42 METAL CUTTER ATTACHMENT M16-77093/42 MINI CRANITOME ATTACHMENT M14-31593/42 MINI CRANITOME ATTACHMENT M16-31593/42 MINI DRILL LIMIT GUIDE M14-33793/42 MOTOR CABLE M14-31093/42 PERFORATOR MOTOR HANDPIECE M14-35293/42 PERFORATOR MOTOR HANDPIECE M16-35293/42 POWER CONSOLE M14-40593/42 ROTATIONAL ADULT GUIDE M14-32593/42 ROTATIONAL ADULT GUIDE M14-34793/42 ROTATIONAL ADULT GUIDE M16-34793/42 ROTATIONAL LAMINECTOMY GUIDE M14-32693/42 ROTATIONAL PEDIATRIC GUIDE M14-32493/42 ROTATIONAL PEDIATRIC GUIDE M14-34693/42 ROTATIONAL PEDIATRIC GUIDE M16-34693/42 STRAIGHT ATTACHMENT 100 MM M14-13093/42 STRAIGHT ATTACHMENT 100 MM M16-13093/42 STRAIGHT ATTACHMENT 150 MM M14-16093/42 STRAIGHT ATTACHMENT 150 MM M16-16093/42 STRAIGHT ATTACHMENT 20 MM M14-10093/42 STRAIGHT ATTACHMENT 20 MM M16-10093/42 STRAIGHT ATTACHMENT 40 MM M14-11093/42 STRAIGHT ATTACHMENT 40 MM M16-11093/42 STRAIGHT ATTACHMENT 60 MM M14-12093/42 STRAIGHT ATTACHMENT 60 MM M16-12093/42	IIa 93/42	Website EUDAMED record Report an error
Emd	Hungary	Control unit MultiSmart93/42 Craniotome handpiece MultiSmart93/42 Craniotome head, L11, Fix MultiSmart93/42 Craniotome head, L11, Rotatable MultiSmart93/42 Craniotome head, L15, Fix MultiSmart93/42 42 others Craniotome head, L15, Rotatable MultiSmart93/42 Craniotome head, L25, Fix MultiSmart93/42 Craniotome head, L25, Rotatable MultiSmart93/42 Curved Slim head, L105 MultiSmart93/42 Curved Slim head, L125 MultiSmart93/42 Curved Slim head, L85 MultiSmart93/42 Fluid bottle holder for NSS-110 MultiSmart93/42 Footswitch MultiSmart93/42 Handpiece head MultiSmart93/42 High-speed motor MultiSmart93/42 Instrument tray MultiSmart93/42 Laminotome head, L35, Fix MultiSmart93/42 Laminotome head, L35, Rotatable MultiSmart93/42 Linear Slim head, L105 MultiSmart93/42 Linear Slim head, L125 MultiSmart93/42 Linear Slim head, L85 MultiSmart93/42 Oil spray nozzle MultiSmart93/42 Oiling spray MultiSmart93/42 Perforator handpiece MultiSmart93/42 Rinse-wash device MultiSmart93/42 Slim handpiece, Angled MultiSmart93/42 Standard handpiece, L120 A, Angled MultiSmart93/42 Standard handpiece, L120 S, Straight MultiSmart93/42 Standard handpiece, L170 A, Angled MultiSmart93/42 Standard handpiece, L170 S, Straight MultiSmart93/42 Standard handpiece, L220 A, Angled MultiSmart93/42 Standard handpiece, L220 S, Straight MultiSmart93/42 Standard handpiece, L25 A, Angled MultiSmart93/42 Standard handpiece, L25 S, Straight MultiSmart93/42 Standard handpiece, L45 A, Angled MultiSmart93/42 Standard handpiece, L45 S, Straight MultiSmart93/42 Standard handpiece, L70 A, Angled MultiSmart93/42 Standard handpiece, L70 S, Straight MultiSmart93/42 Standard handpiece, L95 A, Angled MultiSmart93/42 Standard handpiece, L95 S, Straight MultiSmart93/42 Standard irrigation adapter, L120 MultiSmart93/42 Standard irrigation adapter, L170 MultiSmart93/42 Standard irrigation adapter, L220 MultiSmart93/42 Standard irrigation adapter, L25 MultiSmart93/42 Standard irrigation adapter, L45 MultiSmart93/42 Standard irrigation adapter, L70 MultiSmart93/42 Standard irrigation adapter, L95 MultiSmart93/42	IIb 93/42	Website EUDAMED record Report an error
Tonica Elektronik A S FDA	Denmark	Coil C-10093/42 Coil C-B6093/42 Coil C-B7093/42 Coil Cool D-B8093/42 Coil Cool D-B80 A/P93/42 39 others Coil Cool-12593/42 Coil Cool-B3593/42 Coil Cool-B35 HO93/42 Coil Cool-B35 RO93/42 Coil Cool-B6593/42 Coil Cool-B65 A/P93/42 Coil Cool-B65 A/P CO93/42 Coil Cool-B65 A/P RO93/42 Coil Cool-B65 CO93/42 Coil Cool-B65 RO93/42 Coil Cool-B7093/42 Coil Cool-B70 A/P93/42 Coil Cool-D5093/42 Coil D-B8093/42 Coil MC-12593/42 Coil MC-B3593/42 Coil MC-B65-HO-293/42 Coil MC-B65-HO-893/42 Coil MC-B7093/42 Coil MCF-12593/42 Coil MCF-7593/42 Coil MCF-B6593/42 Coil MCF-B7093/42 Coil MMC-14093/42 Coil MMC-140 A/P93/42 Coil MMC-140-II93/42 Coil MMC-9093/42 Coil MRi-B9193/42 Coil MRi-B91 Air Cooled93/42 Coil RT-12093/42 Coil RT-120-II93/42 External Control Program93/42 MagPro Compact93/42 MagPro R202 refs93/42 MagPro R3093/42 MagPro R30 incl. MagOption93/42 MagPro X10093/42 MagPro X100 incl. MagOption93/42 MEP Monitor93/42	IIa 93/42	regulatory@magventure.com EUDAMED record Report an error
Inomed FDA	Germany	Anschlusskabel für Alcis sEEG Elektrode 2600603 refs C2 NerveMonitor C2 4-Kanal-System 50824093/42 C2 NerveMonitor C2 8-Kanal-System 50828093/42 C2 Xplore 50828893/42 Führungsrohr für RF TC Brain Electrode 26059593/42 36 others ISIS Headbox 16 Ch. DIF 50427193/42 ISIS Headbox 16Ch. REF - AEP 50428193/42 ISIS Headbox 16Ch. REF 50426193/42 ISIS Headbox 8Ch. DIF - 8Ch. REF - AEP 50428593/42 ISIS Headbox U8DRD 50427093/42 ISIS Headbox U8DTP 50427593/42 ISIS Headbox U8SRD 50426093/42 ISIS Headbox U8SRD-AEP 50428093/42 ISIS Headbox U8STP-AEP 50426593/42 ISIS MER System Kompakt Komplettsystem 5901023 refs ISIS Neurostimulator 50418093/42 ISIS Neurostimulator Komplettsystem 504185 ISIS System Base Unit 504000 ISIS Xpert Plus System 5040042 refs ISIS Xpress System für individuelle Konfiguration 504006 LG1, RF-Läsionsgenerator, 1 Kanal Stimulation, Kont. und Gepulste RF 26100093/42 LG2, RF-Läsionsgenerator, 2 Kanal Stimulation, Kont. und Gepulste RF 26200093/42 LG2-sEEG, RF-Läsionsgenerator 1 Kanal TC und 1 Kanal sEEG 26300093/42 RF TC Brain Electrode 1x1,5 asymetrisch,Typ:TCBA 011 26051193/42 RF TC Brain Electrode bipolar 1x1,5mm, Typ:TCB012 26051293/42 RF TC Brain Electrode bipolar 2x2mm, Typ:TCB013 26051393/42 RF TC Brain Electrode monopolar 1x1,5mm, Typ:TCU001 26050193/42 RF TC Brain Electrode monopolar 1x3mm,Typ:TCU002 26050293/42 RF TC Brain Electrode monopolar 2x4mm,Typ:TCU003 26050393/42 SUSy Stereotaxiesystem für Keramikring 8080002 refs TC-Schmerz-Elektrode 100mm mit 7-pol. Lemosa-Kupplung 26001093/42 TC-Schmerz-Elektrode 100mm mit inomed SuperLight-Stecker 26001193/42 TC-Schmerz-Elektrode 150mm mit 7-pol. Lemosa-Kupplung 26001593/42 TC-Schmerz-Elektrode 150mm mit SuperLight-Stecker 26001693/42 TC-Schmerz-Elektrode 50mm mit 7-pol. Lemosa-Kupplung 26000593/42 TC-Schmerz-Elektrode 50mm mit inomed SuperLight-Stecker 26000693/42 TC-Trigeminus-Elektrode mit 7-pol. Lemosa-Kupplung 26012693/42 TC-Trigeminus-Elektrode mit inomed SuperLight-Stecker 26012193/42 Thermosonde für Kombi-Elektrode. Art.230777 26056193/42 ZD Befestigungsschiene für offenen Ring 8020102 refs Äußeres Führungsrohr für RF TC Brain Electrode 26059093/42	I, IIa, IIb, III MDR, 93/42	Website info@inomed.com EUDAMED record Report an error
Zethon FDA EU representative : De Soutter Medical Limited (Netherlands)	United Kingdom (ex Northern Ireland)	A-C0793/42 A-C07S93/42 A-C1093/42 A-C10S93/42 A-C12S93/42 33 others A-C1593/42 A-C15S93/42 A-C18S93/42 A-D1493/42 A-M0193/42 C-C0993/42 C-C1093/42 C-D1293/42 ES-C07S93/42 Foot control pedals used in combination with surgical power tools to ream, bur, drill and cut bone3 refs HDS-11193/42 HDS-12193/42 HDS-12293/42 HDS-14393/42 M-D0693/42 P-P0193/42 P-P0293/42 S-C0793/42 S-C07S93/42 S-C0893/42 S-C08S93/42 S-C1093/42 S-C10S93/42 S-C12S93/42 S-C1593/42 S-C15S93/42 S-C18S93/42 S-D0993/42 S-D1493/42 S-D2693/42 S-D3193/42 S-D31S93/42 S-M0393/42	I, IIa, III MDR, 93/42	regulatory@zethon.com EUDAMED record Report an error
Compumedics FDA EU representative : Compumedics EUROPE GmbH (Germany)	Australia	Falcon Docking Cradle Assembly Falcon HST System EU3 refs Falcon HST System93/42 Grael DC Assembly with Cable93/42 Grael EEG - EU3 refs Grael Extension Box93/42 21 others Grael LT System, no software93/42 Grael PSG Package -Grael PG, PSG Starter Kit93/42 Grael PSG System, No software93/42 Grael v2 System with PSG 5 Software93/42 Neuvo System Unit3 refs Okti 128 Ch Ambulatory EEG Recorder Only3 refs Okti 128 Ch Ambulatory EEG System93/42 Okti 128 Ch Wall Mount System93/42 Okti 32 Ch Ambulatory EEG System93/42 Okti 32 Ch Fixed System93/42 Okti 64 Ch Ambulatory EEG System93/42 Okti Ethernet Connection Kit93/42 Respifit Device - Somfit Pro upgrade kit3 refs Somfit Pro System EU93/42 Somfit System Europe93/42 Somfit System Europe (7 electrodes)93/42 Somte PSG v22 refs SynAmps RT System Unit Package + IMECSU-2 SynAmps2/RT3 refs SynAmpsRT 64-Channel Headbox Package93/42 SynAmpsRT Power Unit Package93/42 SynAmpsRT System Unit Package93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Sigmastim FDA EU representative : ICON (LR) Limited (Ireland)	United States	Adjustable Headband ECG Safety Leads (White, Green, Black) ECG Safety Leads IEC (Red, Green, Yellow) ECT Cotton Bite Blocks Size Large ECT Cotton Bite Blocks Size Medium 27 others EEG Green Reference Lead EEG Safety Leads (Brown) EEG Safety Leads (Gray) EEG/EEG Five-Lead Set EMG Safety Leads (Blue) Safety Monitor Cable EEG1/EEG2 Safety Monitor Cable EEG3/EEG4 Sigma Dual Hand-Held Electrode Assembly with Push Button Sigma Dual Hand-Held Electrode Assembly without Push Button Sigma Safety Monitor Cable DOM ECG/EMG Sigma Safety Monitor Cable IEC ECG/EMG Sigma Single Hand-Held Electrode Assembly with Push Button Sigma Single Hand-Held Electrode Assembly without Push Button SigmaStim Sigma 200J SigmaStim Σigma 200J93/42 Two Concave Stimulus Electrodes Two Flat Stimulus Electrodes OMS Cable (no longer marketed) spECTrum Dual Hand-Held w/ Remote (replacement) (no longer marketed) spECTrum Dual Hand-Held w/o Remote (replacement) (no longer marketed) spECTrum EEG/ECG Five-Lead Set (replacement) (no longer marketed) spECTrum EEG/ECG Five-Lead Set-IEC (replacement) (no longer marketed) spECTrum Patient Stimulus Cable (replacement) (no longer marketed) spECTrum Safety Monitor Cable DOM EEG/ECG (replacement) (no longer marketed) spECTrum Safety Monitor Cable IEC EEG/ECG (replacement) (no longer marketed) spECTrum Single Hand-Held w/o Remote (replacement) (no longer marketed) spECTrum Single Hand-Held w/Remote (replacement) (no longer marketed)	I, IIb MDR, 93/42	Website EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	ELECTRIC STEALTH-MIDAS STYLUS LEGEND ELECTRIC MOTOR LEGEND ELECTRIC MOTOR STYLUS LEGEND GOLD TOUCH MOTOR LEGEND PLATINUM MOTOR 13 others LEGEND STEALTH-MIDAS PNEUMATIC MOTOR MIDAS REX MICROSAW5 refs MOTOR LEGEND GOLD MOTOR MR7 PNEUMATIC MOTOR MR7 TOUCH PNEUMATIC MOTOR MR8 ELECTRIC MOTOR MR8 ELECTRIC NAVIGATED S8 MOTOR MR8 ELECTRIC TOUCH MOTOR MR8 PNEUMATIC MOTOR MR8 PNEUMATIC MOTOR NAVIGATED MR8 PNEUMATIC MOTOR TOUCH Nerve Monitoring Equipment NIM4CM01 Nerve Monitoring Patient Interface NIM4CPB1	IIa MDR	EUDAMED record Report an error
electroCore FDA EU representative : MDSS GmbH (Germany)	United States	ECOR gammaCore Sapphire D Evaluation Device Kit 36-month Preprogrammed93/42 ECOR gammaCore Sapphire Device Kit 31-Days2 refs93/42 ECOR gammaCore Sapphire Device Kit 93-days2 refs93/42 ECOR gammaCore Sapphire Refill Card Kit 31-days93/42 ECOR gammaCore Sapphire Refill Card Kit, 93-days93/42 14 others ECOR gammaCore Sapphire SLC 93 Day Evaluation Kit (kit with refill card)93/42 ECOR gammaCore Sapphire SLC Device Kit 31-Days (Kit with refill card)6 refs93/42 ECOR gammaCore Sapphire SLC Device Kit 93-Days (Kit with refill card)5 refs93/42 ECOR gammaCore Sapphire SLC Device Kit, 93 Day (kit with refill card)93/42 ECOR gammaCore Sapphire SLC Refill Card Kit 31-Days4 refs93/42 ECOR gammaCore Sapphire SLC Refill Card Kit 93-Days5 refs93/42 gammaCore Sapphire 31-Day Starter Kit3 refs gammaCore Sapphire SLC EVAL Refill Card Kit gammaCore Sapphire SLC Evaluation Refill Card Kit93/42 gammaCore Sapphire SLC Refill Card Kit, 31 days93/42 ECOR gammaCore Sapphire D Device Kit 36-Month Preprogrammed3 refs93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Device Kit for Evaluation (kit with refill card)93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Evaluation Kit 93-Day ( Kit with refill card)93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Refill Card Evaluation Kit93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Refill Card Evaluation Kit 93-days93/42 (no longer marketed)	IIa MDR, 93/42	Website info@electrocore.com EUDAMED record Report an error
Natus FDA EU representative : Natus Manufacturing Ltd (Ireland)	Canada, United States	Cortical Stimulator Control Unit3 refs EMU40 Battery Pack Enclosure EMU40EX Class I Accessories2 refs EMU40EX with new Natus Base2 refs ErgoJust EMG Cart For Nicolet EDX Lemo Patient call cord 2’3 refs 9 others Natus Base Unit3 refs Natus Quantum Patient Event Button 30 ft. (1.5 m)2 refs Natus Quantum Quantum (Phase II) 64-channel Breakout3 refs NATUS TEMPERATURE PROBE ADAPTER UltraPro S1003 refs Olympic Brainz Monitor(OBM) OBM Viewer CD - V3.1.53 refs Reusable Jumper Linker Cable3 refs Single Use Universal RIP Kit - Abdomen3 refs Trex Ext. Battery Cable3 refs UltraPro UB3 Cart 0223302 refs	I, IIa, IIb MDR	Website EUDAMED record Report an error
SOMNOmedics FDA	Germany	32-channel EEG Headbox for SOMNO HD3 refs 6-channel EEG-Module EEG-Headbox3 refs Add-on device: SOMNOtouch NIBP3 refs Add-on device: SOMNOtouch PSG ambulatory (AASM) SOMNOtouch RESP3 refs Headbox, basic version EEG-Headbox2 refs 8 others JFD5001 SOMNOtouch3 refs JFD7001HD SOMNO HD3 refs NARCOguide, Basic-Version3 refs Sleep Adagio® PG6 refs SOMNO HD EEG 323 refs SOMNOscreen plus EEG 32 BT3 refs SOMNOscreen™ plus SOMNOtouch wireless3 refs	IIa, IIb MDR	Website EUDAMED record Report an error
Nox Medical FDA	Iceland	A1s Recorder APSG1SEU93/42 A1s System NOX-A1S_EUF C1s Kit EU NOX-C1SKIT193/42 Nox A1S SAS kit Nox C1 Access Point NOX-SCOM193/42 3 others Nox C1 Kit NOX-C1KIT193/42 Nox T3s System, EU NOX-T3S_EUF T3s Recorder EU ASDB1SEU93/42	IIa MDR, 93/42	Website support@noxmedical.com EUDAMED record Report an error
Elekta FDA	Sweden	CT-Adapter, Adjustable Leksell Stereotactic System (Class I)3 refs DISPOSABLE INSERTS 4 PCS FirmFix 13 refs FirmFix Ruler Leksell Vantage Stereotactic System (Class I)3 refs FIXATION SCREW 110MM TITANIUM Fixation Screws 20mm-110mm3 refs 2 others Frame G with Straight/Curved Front Leksell Stereotactic System (Class I(m))3 refs Leksell Vantage Arc System (Class Im)	I, IIa MDR	EUDAMED record Report an error
Zimmer FDA	Germany	ContiCure93/42 CoolTone93/42 emFieldPro93/42 FREI-emPact emFieldPro93/42 M-Tec Mag S93/42 2 others MFG-03 (ZField Dual)93/42 StimSure MFG-0393/42	IIa 93/42	Website info@zimmer.de EUDAMED record Report an error
Dr. Langer Medical	Germany	AEP-Link Kabel3 refs AVALANCHE® PLUS3 refs AVALANCHE® XT Neuromonitor3 refs Footswitch2 refs Neurostimulator TWISTER® TC3 refs 1 other Sondenkabel für AVALANCHE®-Headbox & TWISTER® Light, Kabellänge 2,5 m3 refs	I, IIa MDR	Website info@medical-langer.de EUDAMED record Report an error
Soterix Medical FDA EU representative : mdi Europa GmbH (Germany)	United States	1300A93/42 150093/42 160193/42 1601A93/42 200193/42 1 other SNAPpad™ Electrode SMI_SNAPpad_5x5	I, IIa MDR, 93/42	contact@soterixmedical.com EUDAMED record Report an error
Balt Usa FDA EU representative : BALT EXTRUSION SAS (France)	United States	Detachment Cable CBL00293/42 Detachment Controller93/42 Endovascular Embolization Coil134 refs93/42 Neurovascular embolization device209 refs93/42 Peripheral Embolization Device206 refs93/42	I, IIa, IIb, III 93/42	Website PRRC@baltgroup.com EUDAMED record Report an error
Digitimer FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	D18593/42 DS593/42 DS7A93/42 DS7AH93/42 DS7AP93/42	IIa 93/42	Website sales@digitimer.com EUDAMED record Report an error
Eemagine FDA	Germany	eego amplifier EE-xxx3 refs eego ES-220 eego LE-200 neo monitor ES-820 neo monitor LE-800	IIa MDR	Website EUDAMED record Report an error
Luciole Medical EU representative : Veranex Germany GmbH (Germany)	Switzerland	RheoConnect 1.0 Dräger2 refs RheoControl 3.0 RheoLity 2.6 RheoPatch Knob with cable 2.0, 1 meter RheoPatch 2.02 refs RheoSens 20020	I, IIa, III MDR	Website info@luciolemedical.ch EUDAMED record Report an error
Liability Research Production Enterprise Dх-Systems EU representative : Nilas MV GmbH (Germany)	Ukraine	DX BRAINTEST PLUS93/42 DX M-TEST93/42 DX M-TEST ONE93/42 Electroencephalographic computer complexes DX BRAINTEST93/42	IIa 93/42	Website EUDAMED record Report an error
Lifelines FDA EU representative : Incereb Ltd (Ireland)	United Kingdom (ex Northern Ireland)	R402 refs Trackit T43 refs Trackit T4A3 refs Trackit T4A EEG Amplifier93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
MAG & More FDA	Germany	Apollo Stimware 303 refs Apollo TMS Therapy System 100 V3 refs HANS-aCool Stimulation Coils3 refs PowerMAG Clinical 100 (220 V)3 refs	IIa MDR	Website support@magandmore.com EUDAMED record Report an error
Nefmed medikal ürünleri inşaat otomotiv dış ticaret A.Ş	Türkiye	Diamond46 refs93/42 Elmas18 refs93/42 Surgical Motor System15 refs93/42 Twist Drill8 refs93/42	IIa 93/42	Website info@nefmedical.com EUDAMED record Report an error
neuroConn FDA	Germany	DC-STIMULATOR DC-STIMULATOR MOBILE - APCS 30R12103 refs knitted tES-Cap Sponge pads 30R506x	I, IIa MDR	Website info@neurocaregroup.com EUDAMED record Report an error
Neuroelectrics FDA	Spain	Enobio 2093/42 Enobio 3293/42 Enobio 893/42 Kid Neoprene Headcap3 refs	I, IIa MDR, 93/42	Website info@neuroelectrics.com EUDAMED record Report an error
Neurovirtual FDA EU representative : Obelis s.a. (Belgium)	United States	BWIII Basics3 refs BWIII PSG2 refs BWMini EEG BWMini HST3 refs	IIa MDR	Website info@neurovirtual.com EUDAMED record Report an error
Nexstim FDA	Finland	Navigated Brain Stimulation System93/42 NBS 6 Nexstim NBS System 6 NexSpeech93/42 Nexstim Navigated Brain Therapy System93/42	IIa MDR, 93/42	Website info@nexstim.com EUDAMED record Report an error
Raumedic FDA	Germany	Spliceable Tunneling Sleeve CH1293/42 Spliceable Tunneling Sleeve CH893/42 Tunneling KIT CH1293/42 Tunneling KIT CH893/42	IIa 93/42	Website contact@raumedic.com EUDAMED record Report an error
Cometa FDA	Italy	Myowise MWPB Wave Plus Wireless EMG2 refs WaveX2 refs Myon Aktos93/42 (no longer marketed)	I, IIa MDR, 93/42	Website sales@cometasystems.com EUDAMED record Report an error
Cadwell FDA EU representative : AR Experts B.V. (Netherlands)	United States	Arc Zenith Neuro Accessory3 refs Cadwell Guardian IONM3 refs Cadwell Neuro Accessory3 refs	I, IIa MDR	Website info@cadwell.com EUDAMED record Report an error
Contecmed FDA EU representative : Prolinx GmbH (Germany)	China	Digital Brain Electric Activity Mapping KT88 Digital Brain Electric Activity Mapping KT88-240093/42 EMG/EP System CMS6600B, CMS66002 refs	IIa MDR, 93/42	Website pms.qms@contecmed.com EUDAMED record Report an error
Itamar Medical FDA EU representative : Arazy Group GmbH (Germany)	Israel	WatchPAT™ Central Plus Sensor Watch-PAT3003 refs WatchPAT™400 WatchPAT400 WatchPAT™ONE3 refs	IIa MDR	Website customersupportrow@zoll.com EUDAMED record Report an error
Masimo FDA EU representative : MDSS GmbH (Germany)	United States	SedLine2 refs93/42 SedLine Module2 refs93/42 smartSedLineTM Sedatoin Monitor2 refs	IIb MDR, 93/42	Website customerorders@masimo.com EUDAMED record Report an error
MedEvolve EU representative : RS Consultancies (Netherlands)	United Kingdom (ex Northern Ireland)	ME-DRE-130 ME-SBE-150 ME-SCC-150	I MDR	Website EUDAMED record Report an error
Medical Data Technology	Belgium	BRAINNET 4 BRAINNET 5 DREAM	IIa MDR	Website contact@medatec.be EUDAMED record Report an error
Meditech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	EEG Device B-Rec93/42 EEG Device B-Rec2493/42 EEG Device B-Rec3293/42	IIa 93/42	Website sales@meditech.cn EUDAMED record Report an error
Megin FDA	Finland	Elekta Neuromag® TRIUX NM23900N93/42 Elekta Neuromag® TRIUX NM25000N93/42 TRIUX™ neo NM26000N93/42	IIa 93/42	Website qara@megin.fi EUDAMED record Report an error
Micro Therapeutics D B A Ev3 Neurovascular FDA EU representative : Medtronic B.V. (Netherlands)	United States	Artisse Detachment Device Solitaire Cable sets Solitaire Detachment System	I, IIa MDR	EUDAMED record Report an error
Micromed FDA	Italy	BRAIN QUICK93/42 BRAIN QUICK BQS-FLXI-NETP3 refs SD LTM STIM93/42	IIb MDR, 93/42	Website EUDAMED record Report an error
NCCMedical Pte EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Singapore	ExcMT-EEG-F, ExcMT-EEG-E2 refs ExcMT-EMG/EP-F, ExcMT-EMG-F, ExcMT-EMG/EP-D, ExcMT-EMG-D, ExcMT-EMG/EP-C, ExcMT-EMG-C3 refs ExcMT-IONM-HDPro, ExcMT-IONM-HD,ExcMT-IONM-HSPro,ExcMT-IONM-HS3 refs	IIa MDR	EUDAMED record Report an error
Neuromed	France	Evidence EEG613 refs Litebox NM-G034.02-01 Neuron-Spectrum-4/EPM Neuron-Spectrum-52 refs	IIa MDR	Website EUDAMED record Report an error
OT Bioelettronica	Italy	Bruxoff+ Bruxism Monitor Device DUE+ Portable EMG Instrumentation Amplifiers3 refs Novecento+ EMG Instrumentation Amplifiers2 refs	I MDR	Website EUDAMED record Report an error
Somatics FDA EU representative : FBI Medizintechnik GmbH (Germany)	United States	ECT Treatment Cable ECET-P Remote Treatment Handle Thymatron System IV93/42	I, IIb MDR, 93/42	Website sales@thymatron.com EUDAMED record Report an error
Stowood EU representative : Medaptivo EU Ltd. (Ireland)	United Kingdom (ex Northern Ireland)	Stowood Black Flash BF-R93/42 Stowood Black Flash Plus BFP-R93/42 Stowood Black Shadow BS-R93/42	IIa 93/42	Website sales@stowood.co.uk EUDAMED record Report an error
Swlmed	Germany	Helix MDS 103 refs Helix MDS 143 refs Helix MDS 3D3 refs	III MDR	Website EUDAMED record Report an error
Sooma	Finland	ComfoCap, CCL03 refs Sooma DUO DCS6 Sooma tDCS93/42 (no longer marketed)	I, IIa MDR, 93/42	Website regulatory@soomamedical.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott Medical (Belgium)	United States	Dorsal Root Ganglion Stimulation3 refs N/A5 refs	III MDR	EUDAMED record Report an error
Bittium FDA	Finland	Bittium Physior BrainStatus93/42	I, IIa MDR, 93/42	Website EUDAMED record Report an error
BMC Medical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	PolyWatch Portable Sleep Diagnostic System3 refs Portable Sleep Diagnostic System YH-S900B2 refs	IIa MDR	EUDAMED record Report an error
Braebon FDA EU representative : AR Experts B.V. (Netherlands) and 1 other	Canada	MediByte Jr MP-82 refs MediByte MP893/42	IIa MDR, 93/42	Website info@braebon.com EUDAMED record Report an error
Brainnavi FDA EU representative : MDSS GmbH (Germany)	Taiwan	FPSD010193/42 NaoTrac93/42	I, IIb 93/42	Website service@brainnavi.com EUDAMED record Report an error
BTL Industries FDA EU representative : BTL ITALIA S.r.l. (Italy)	United Kingdom (ex Northern Ireland)	EXOMIND EXOMIND applicator BTL-699-AP-M-2	IIa MDR	EUDAMED record Report an error
Burl Concepts EU representative : ICON (LR) Limited (Ireland)	United States	SONAS 100052 SONAS 100172	I, IIa MDR	Website EUDAMED record Report an error
Cerenovus FDA EU representative : DePuy Ireland UC (Ireland)	United States	Connecting Cable2 refs ENPOWER detachment control box	I, IIa MDR	Website EUDAMED_Enquiries@its.jnj.com EUDAMED record Report an error
Checkpoint Surgical FDA EU representative : WMDE B.V. (Netherlands)	United States	Checkpoint Surgical Head & Neck Nerve Stimulator 939493/42 Checkpoint Surgical Nerve Stimulator 909493/42	IIa 93/42	Website Regulatory@checkpointsurgical.com EUDAMED record Report an error
Dirostech FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	MLA-4 URF-3AP(ML)	IIb MDR	Website info@dirostech.com EUDAMED record Report an error
Dr. Fenyves und Gut Deutschland	Germany	MiniScreen Pro Patient Recorder3 refs SleepDoc Porti 10 PSG Neuro Module3 refs	IIa MDR	info@fg-deutschland.de EUDAMED record Report an error
EB Neuro FDA	Italy	NeMus 2 VEP NExT3 refs	IIb MDR	Website info@ebneuro.com EUDAMED record Report an error
Empatica FDA	Italy	EpiMonitor by Empatica iOS Version2 refs EpiMonitor Flamingo pink3 refs	IIa MDR	Website info@empatica.com EUDAMED record Report an error
Esumedics	Germany	esumedics EEG esumedics EEG System	IIb MDR	Website info@esumedics.com EUDAMED record Report an error
FHC FDA EU representative : TERMOBIT PROD SRL (Romania)	United States	Guideline 4000™ 5.0 MT-LPP3 refs microTargeting™ Guideline 4000 LP+™ Cart GL5 Accessories (Cart, breakout box, Lead Adapters)3 refs	I, IIa MDR	Website EUDAMED record Report an error
Gtec FDA	Austria	cortiQ PRO3 refs g.Estim PRO93/42	IIb MDR, 93/42	Website EUDAMED record Report an error
Integralife FDA EU representative : Integra LifeSciences Services (France)	United States	CODMAN CERTAS®2 refs CODMAN®3 refs	I MDR	EUDAMED record Report an error
Mrc Systems Medizintechnische Systeme FDA	Germany	OptiHair23 refs PinPrick PP053 refs	I MDR	Website info@mrc-systems.de EUDAMED record Report an error
Phagenesis FDA EU representative : Veranex Germany GmbH (Germany)	United Kingdom (ex Northern Ireland)	Phagenyx EPSB3 Phagenyx EPSB4	IIa MDR	Website info@phagenesis.com EUDAMED record Report an error
Prolira FDA	Netherlands	DeltaScan Monitor R2 DeltaScan R3	IIa MDR	Website EUDAMED record Report an error
Re5	Denmark	Re5 Neuro Treatment System Re5-NTS Re5 Parkinson Treatment System Re5-PTS	IIa MDR	Website info@re5.com EUDAMED record Report an error
Sibel Sau	Spain	Polígrafo Screen&Go3 refs Sistema Screen&Go3 refs	IIa MDR	Website EUDAMED record Report an error
SIGMA Medizin-Technik	Germany	NEUROWERK EEG NEUROWERK EMG	IIa MDR	EUDAMED record Report an error
Acurable FDA EU representative : Acurable SLU (Spain)	United Kingdom (ex Northern Ireland)	Acurable Limited SA10093/42	IIa 93/42	EUDAMED record Report an error
Aesculap FDA	Germany	ELAN 4 electro drill	IIa MDR	Website eudamed@bbraun.com EUDAMED record Report an error
Alpha Omega Engineering FDA EU representative : Alpha Omega GmbH (Germany)	Israel	CRW Non-XY frame Mechanical Set KIT	I MDR	Website EUDAMED record Report an error
Andon Health FDA EU representative : iHealthLabs Europe SAS (France)	China	TENS AD-212693/42	IIa 93/42	EUDAMED record Report an error
Artinis	Netherlands	MediBrite2 refs	I MDR	Website EUDAMED record Report an error
Aurimod	Austria	VIVO2 refs	IIa MDR, 93/42	Website office@aurimod.com EUDAMED record Report an error
Beneeon (Jiangsu) Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Intraoperative Nerve Monitoring System BN-JCY-2203 refs	IIa MDR	sales@bnycmed.com EUDAMED record Report an error
Bioretina	Türkiye	MG10 MAGNOVISION	IIb MDR	Website EUDAMED record Report an error
Blueback	France	INNER UP IUP-01	I MDR	Website contact@blueback.fr EUDAMED record Report an error
BrainCapture	Denmark	BC-1	IIa MDR	Website info@braincapture.dk EUDAMED record Report an error
Braincare (Beijing) medical device EU representative : NEO HEALTHIES LIMITED (Ireland)	China	SE-A10-L、SE-A10-N、SE-A11-L、SE-A11-N、SE-P10-L、SE-P10-N、SE-P11-L、SE-P11-N	I MDR	Website EUDAMED record Report an error
Brainhero	Austria	Orbit	IIa MDR	Website EUDAMED record Report an error
Brainmaster FDA EU representative : mdi Europa GmbH (Germany)	United States	Atlantis 2EB+ Discovery 203 refs	IIa MDR	Website sales@brainm.com EUDAMED record Report an error
BrainsWay FDA EU representative : Obelis s.a. (Belgium)	Israel	104A All in one service kit TOUCH SCREEN Model 1043 refs	IIb MDR	Website info@brainsway.com EUDAMED record Report an error
Byteflies FDA	Belgium	EpiCare Absence EpiCare@Home3 refs	I MDR	Website hello@byteflies.com EUDAMED record Report an error
Cidelec	France	Hypnea 22 refs	IIa MDR	Website info@cidelec.net EUDAMED record Report an error
ClearPoint Neuro FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	SmartTwist MR Hand Drill NGS-HD-01	I MDR	Website regulatory@clearpointneuro.com EUDAMED record Report an error
DeMeTec	Germany	VAS593/42	IIa 93/42	Website EUDAMED record Report an error
Deymed FDA	Czechia	DuoMAG MP3 refs	IIa MDR	Website regulatory@deymed.com EUDAMED record Report an error
Diers FDA	Germany	DIERS iEMG	I MDR	Website EUDAMED record Report an error
El.En FDA	Italy	STIMUL 1340	IIa MDR	Website info@elen.it EUDAMED record Report an error
FIAB FDA	Italy	Ring electrode F8903/13 refs	I MDR	Website quality@fiab.it EUDAMED record Report an error
General ASDE	Spain	ASDE Driver Test N-845	I MDR	Website EUDAMED record Report an error
HippoScreen Neurotech FDA EU representative : Luana Med. B.V. (Netherlands)	Taiwan	8-CH Electroencephalography Amplifier EAmp-0001	IIa MDR	EUDAMED record Report an error
InfraScan FDA EU representative : QbD RepS BV (Belgium)	United States	Infrascanner 20002 refs	IIa MDR	Website support@infrascanner.com EUDAMED record Report an error
Institut Du Cerveau Et De La Moelle Epiniere	France	TraumaCare	I MDR	Website EUDAMED record Report an error
Ionclinics	Spain	Home tDCS EPTEV01	IIa MDR	Website info@ionclinics.com EUDAMED record Report an error
Kaneka FDA EU representative : Kaneka Medical Europe N.V. (Belgium)	Japan	ELECTRO DETACH GENERATOR v42 refs	IIb MDR, 93/42	Website EUDAMED record Report an error
Kilde &	Denmark	Kilde Medic Biothesiometer2 refs	I MDR	Website EUDAMED record Report an error
Micromar FDA EU representative : Emergo Europe B.V. (Netherlands)	Brazil	EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm3 refs	IIa MDR	Website EUDAMED record Report an error
Mindmore	Sweden	Mindmore	IIa MDR	Website info@mindmore.com EUDAMED record Report an error
Monitortechnik FDA	Germany	Braintrend Module3 refs	IIb MDR	info@monitortechnik.de EUDAMED record Report an error
Nakanishi FDA EU representative : NSK Europe GmbH (Germany)	Japan	P200-PER93/42	IIa 93/42	Website EUDAMED record Report an error
Neuro Event Labs FDA	Finland	Nelli93/42	I 93/42	Website contact@neuroeventlabs.com EUDAMED record Report an error
Neurolief FDA EU representative : MDSS GmbH (Germany)	Israel	Relivion MG RLV3	IIa MDR	Website EUDAMED record Report an error
Neurotronics FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	United States	Sphinx PMU7102 refs93/42	IIa 93/42	Website quality@neurotronics.com EUDAMED record Report an error
Neurovisionmedical FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Neurovision Medical Products Inc.2 refs	IIa MDR	EUDAMED record Report an error
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	Japan	EEG Amplifier Unit JE-940A3 refs	IIa MDR	Website information@db.nkc.co.jp EUDAMED record Report an error
Nuraleve EU representative : Obelis s.a. (Belgium)	Canada	SmartStim M1000	IIa MDR	Website regulatory.affairs@nuraleve.com EUDAMED record Report an error
Okuvision	Germany	OkuStim 2	IIa MDR	Website info@okuvision.de EUDAMED record Report an error
Onera FDA	Netherlands	ONERA STS I14 refs93/42	IIa 93/42	Website info@onerahealth.com EUDAMED record Report an error
Qviti	Poland	nurostym tESm93/42	IIa 93/42	Website EUDAMED record Report an error
Recbioengineering	Italy	BAM M022 refs	I MDR	Website EUDAMED record Report an error
Remed FDA EU representative : Obelis s.a. (Belgium)	South Korea	BrainStim, TAMAS, ALTMS3 refs	IIb MDR	EUDAMED record Report an error
Renishaw Mayfield FDA	France	neuromate stereotactic system	IIb MDR	EUDAMED record Report an error
Rhythmlink FDA EU representative : mdi Europa GmbH (Germany)	United States	2.3mm Tapered Ball Tip Stimulating Probe3 refs	IIa MDR	Website quality@rhythmlink.com EUDAMED record Report an error
Shanghai NCC Electronic EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Cynapse IONM System IONM-HDPro, IONM-HD, IONM-HSPro, IONM-HS3 refs	IIb MDR	EUDAMED record Report an error
Shapemem FDA EU representative : MedR-AR Services B.V. (Netherlands)	United States	TrelliX Detachment Controller TDC-193/42	IIa 93/42	info@shapemem.com EUDAMED record Report an error
Shenzhen Delica Medical Equipment FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Electroencephalograph (EEG) EEG-810293/42	IIa 93/42	quality@delicasz.com EUDAMED record Report an error
Sinfomed	Germany	orthoS8 (2-Channel), orthoS8 (4-Channel), orthoS8 (6-Channel), orthoS8 (8-Channel)3 refs	I MDR	Website EUDAMED record Report an error
Somno Engineering	France	SLEEPSCAN	IIa MDR	Website EUDAMED record Report an error
Storz Medical FDA EU representative : STORZ MEDICAL Deutschland GmbH (Germany)	Switzerland	NEUROLITH93/42	IIb 93/42	Website info@storzmedical.com EUDAMED record Report an error
Syneika	France	SYNEIKA ONE93/42	IIb 93/42	Website contact@syneika.com EUDAMED record Report an error
Tovacompany FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	T.O.V.A. 9 System93/42	I 93/42	Website regulatory@tovacompany.com EUDAMED record Report an error
Vibrosense	Sweden	VibroSense Meter II	I MDR	Website info@vibrosense.com EUDAMED record Report an error
Vygon FDA	Italy	PLEXYGON	IIa MDR	Website info-it@vygon.com EUDAMED record Report an error
Wallaby Medical FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Avenir Coil System 10USC010013 refs	III MDR	EUDAMED record Report an error
Ybrain FDA EU representative : KTR Europe GmbH (Germany)	South Korea	Ybrain Inc. YDS-301N93/42	IIa 93/42	Website ra@ybrain.com EUDAMED record Report an error
Yellowriders	Netherlands	Karman Line	I MDR	Website EUDAMED record Report an error
Yiruide EU representative : Wellkang Ltd (Northern Ireland)	China	NS 1000 magnetic stimulator NS 1000, NS 1000A, NS 1000B3 refs	IIb MDR	Website EUDAMED record Report an error
YLAH EU representative : VISAMED GmbH (Germany)	Switzerland	ylah for Depression, Anxiety & Addiction	I MDR	Website info@ylah.ch EUDAMED record Report an error
Zeiss FDA	Germany	OPMI Lumera i	I MDR	Website EUDAMED record Report an error
Μεντιγουει Εισαγωγη & Εμπορια Ιατρικων Νοσοκομειοακων Μηχανηματων Μ. Ε.Π.Ε	Greece	NEURO-PR-01	III MDR	Website EUDAMED record Report an error
Mecta FDA EU representative : ICON (LR) Limited (Ireland) No model still on the market	United States	Adjustable Headband (no longer marketed) ECG Safety Leads (White, Green, Black) (no longer marketed) ECG Safety Leads IEC (Red, Green, Yellow) (no longer marketed) ECT Cotton Bite Blocks Size Large (no longer marketed) ECT Cotton Bite Blocks Size Medium (no longer marketed) 33 others EEG Green Reference Lead (no longer marketed) EEG Safety Leads (Brown) (no longer marketed) EEG Safety Leads (Gray) (no longer marketed) EEG/ECG Five-Lead Set (no longer marketed) EEG/ECG Five-Lead Set-IEC (no longer marketed) EEG/EEG Five-Lead Set (no longer marketed) EMG Safety Leads (Blue) (no longer marketed) MECTA Sigma 200 J93/42 (no longer marketed) OMS Cable (no longer marketed) Safety Monitor Cable EEG1/EEG2 (no longer marketed) Safety Monitor Cable EEG3/EEG4 (no longer marketed) Sigma Dual Hand-Held Electrode Assembly with Push Button (no longer marketed) Sigma Dual Hand-Held Electrode Assembly without Push Button (no longer marketed) Sigma EMR Software (no longer marketed) Sigma Patient Stimulus Cable (no longer marketed) Sigma Safety Monitor Cable DOM ECG/EMG (no longer marketed) Sigma Safety Monitor Cable IEC ECG/EMG (no longer marketed) Sigma Single Hand-Held Electrode Assembly with Push Button (no longer marketed) Sigma Single Hand-Held Electrode Assembly without Push Button (no longer marketed) spECTrum 4000CEM93/42 (no longer marketed) spECTrum 4000CEQ93/42 (no longer marketed) spECTrum 5000CEM93/42 (no longer marketed) spECTrum 5000CEQ93/42 (no longer marketed) spECTrum Dual Hand-Helds with Remote (no longer marketed) spECTrum Dual Hand-Helds without Remote (no longer marketed) spECTrum EMR Software (no longer marketed) spECTrum Patient Stimulus Cable (no longer marketed) spECTrum Safety Monitor Cable DOM EEG/ECG (no longer marketed) spECTrum Safety Monitor Cable IEC EEG/ECG (no longer marketed) spECTrum Single Hand-Held with Remote (no longer marketed) spECTrum Single Hand-Held without Remote (no longer marketed) Two Concave Stimulus Electrodes (no longer marketed) Two Flat Stimulus Electrodes (no longer marketed)	I, IIb MDR, 93/42	Website info@mectacorp.com EUDAMED record Report an error
Respironics FDA EU representative : Respironics Deutschland GmbH & Co.KG (Germany) No model still on the market	United States	"Alice PDx ECG Yoke Cable, Intl "93/42 (no longer marketed) Alice 5 International Base Unit Only 101723093/42 (no longer marketed) Alice 5 International Headbox 101723193/42 (no longer marketed) Alice LE System INTL Alice 5 and Alice LE Polysomnography Systems93/42 (no longer marketed) Alice Night One, Wireless, Ukraine93/42 (no longer marketed) 16 others Alice NightOne Non-Wireless, Warranty, INTL93/42 (no longer marketed) Alice NightOne System Intl, Wireless, Rental93/42 (no longer marketed) Alice NightOne Wireless Device, INTL93/42 (no longer marketed) Alice NightOne Wireless, Warranty ,INTL93/42 (no longer marketed) Alice NightOne, Non-Wireless Device, INTL93/42 (no longer marketed) Alice NightOne, Wireless, Masimo, INTL93/42 (no longer marketed) Alice PDx Core System without Sensors, INTL93/42 (no longer marketed) ALICE PDx Diagnostic System International, Rental93/42 (no longer marketed) Alice PDx ECG Yoke, INTL93/42 (no longer marketed) Alice PDx ExG Yoke, INTL93/42 (no longer marketed) ALICE PDX Portable Sleep Diagnostic System International93/42 (no longer marketed) Alice PDx Sleep Diagnostic System, INTL93/42 (no longer marketed) Alice PDx Unit Only, Warranty Exchange, INTL93/42 (no longer marketed) Cable, ExG Yoke, Alice PDx, Intl. Rental93/42 (no longer marketed) Recert, Alice NightOne Intl93/42 (no longer marketed) Recert, Alice NightOne Intl Wireless93/42 (no longer marketed)	IIa 93/42	eudamed@philips.com EUDAMED record Report an error
Cerenion No model still on the market	Finland	C-Trend(R) 1.0.0.093/42 (no longer marketed)	IIb 93/42	Website info@cerenion.com EUDAMED record Report an error
Charco Neurotech EU representative : European Healthcare & Device Solutions Ltd. (Ireland) No model still on the market	United Kingdom (ex Northern Ireland)	CUE1 for Parkinson's3 refs (no longer marketed)	I MDR	Website info@charconeurotech.com EUDAMED record Report an error
Dadeh Gostaran Dena EU representative : Eska Diagnostics Kft (Hungary) No model still on the market	Iran	ECT Mouth Guard (Disposable Bite Block) GAG-1 (no longer marketed)	I MDR	Website info@dgdena.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) 884

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
Micro Therapeutics, Inc.	United States	Axium™ Detachable Coil System Axium™ Prime Detachable Coil System AxiumTM Axium Prime Detachable Coil System Axium Detachable Coil System Axium PrimeTM	K090046 (2009)
MicroVention, Inc.	United States	V-Trak HydroSoft Helical MicroPlex Helical Soft HydroFill Helical HydroCoil Helical MicroPlex Helical Regular	K223050 (2022)
STRYKER CORPORATION Present in Europe in other categories	United States	Maestro CORE STRYKER RemB Shaver System BPX	K211490 (2021)
Nuvasive, Inc. Present in Europe in other categories	United States	ReLine PULSE MaXcess NVM5 Armada MAS PLIF	K112717 (2012)
DE SOUTTER MEDICAL LIMITED	United Kingdom	De Soutter Medical	registered
Technomed Engineering B.V.	–	Neurosign V4 Technomed Europe Neuroradium Inomed Cadwell Neuroguard	registered
Penumbra, Inc.	United States	Penumbra Coil 400 LP Coil System RUBY Coil Swift Coil System POD POD Packing	K250079 (2025)
Bien-Air Surgery SA Present in Europe in other categories	Switzerland	Bur PM2 80K Steel TD Ø1.1x5 St Bur PM2-95 80K Diam C Ø6.0 St Bur PM2-70 80K Diam Ø4.0 St Bur PM2-70 80K FC Ø2.0 St Bur PM2-95 80K Diam Ø1.0 St Bur PM2-70 80K FC Ø2.5 St	K221184 (2022)
Synthes GmbH Present in Europe in other categories	United States	MatrixMIDFACE Matrix RapidSorb KINCISE™	K093361 (2010)
Peter Lazic GmbH	Germany	LAZIC	K180757 (2019)
MicroPort NeuroTech (Shanghai) Co., Ltd.	China	Numen Numen Helia NumenFR	K260351 (2026)
PMT CORPORATION	United States	DEPTHALON® DEPTHALON ACCUNAV® PMT® CORPORATION - SPHENOIDAL sEEG DEPTHALON® sEEG DEPTHALON	K151790 (2016)
Shanghai Wallaby Medical Technologies Co., Inc.	–	Avenir Avenir Mega Coil System	registered
Cook, Inc.	United States	Hilal MReye Tornado Nester MicroNester Retracta	K160219 (2016)
Ad-Tech Medical Instrument Corporation Present in Europe in other categories	United States	FREMAP Electrode Spinal Electrode Kit Spencer Probe Depth Electrode Macro Depth Electrode Sphenoidal Electrode Set Anchor Bolt Kit, LSB Style	K223269 (2023)
S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD	–	Sleepsense Embla Grass Natus Neurovirtual Clevemed	registered
Spes Medica Srl Present in Europe in other categories	Italy	IOM Stimulator Probes Dragonfly Laryngeal Surface Electrodes Spes Medica Subdermal Needle Electrodes Disposable EMG needle electrodes	K192603 (2019)
Medicon eG. Chirurgiemechaniker-Genossenschaft	–	Medicon	registered
Advanced Brain Monitoring, Inc. Present in Europe in other categories	United States	X-Series X-Series, X8 Sleep Profiler PSG2 Sleep Profiler X8	K152040 (2015)
Karl Storz GmbH & Co. KG Present in Europe in other categories	Germany	n.a. UNIDRIVE DrillCut-X	registered
XLTEK	Canada	Natus Xltek Embla	K014147 (2002)
Stryker Leibinger GmbH & Co. KG Present in Europe in other categories	Germany	Stryker VariSpeed DELTA Universal Neuro 2, Universal Neuro 3 UNIVERSAL 2	registered
BIOMET MICROFIXATION, INC Present in Europe in other categories	United States	IQ SYSTEM 1.5MM SYSTEM ZDRIVE™ 2.0MM SYSTEM TraumaOne SYSTEM "1.5MM" SYSTEM TWIST DRILL	K223199 (2022)
Boston Scientific Corp Present in Europe in other categories	United States	Bead Block™ LC Bead 100-300 LC Bead M1 70-150 Bead Block 700-900 LC Bead 300-500 Bead Block 900-1200	K261488 (2026)
LifeSync Corporation	United States	MULTIFLOW ULTRAFLOW Horizon™ Rochester SurePoint™ UltraPoint	registered
adeor Medical AG	Germany	VELOCITY ALPHA ™ HiCUT Burs HiCUT Micro saw PMT Drill Cutter Meridian Perforator	K253772 (2026)
Bio Protech, Inc. Present in Europe in other categories	United States	Bio Protech PROEMG	K152984 (2016)
GE Healthcare Finland Oy Present in Europe in other categories	Finland	CARESCAPE PORTRAIT AAB01 CARESCAPE B850 CARESCAPE B450 PORTRAIT HSWXB CARESCAPE B650	K191322 (2020)
DIAGNOSYS LLC Present in Europe in other categories	United States	Espion Envoy Mini-OLED ColorDome Desktop Ganzfeld Stimulator ColorBurst Handheld Stimulator EER Stimulator and Amplifier ColorFlash Handheld Stimulator	K221471 (2022)
IMEDICOM CO., LTD. Present in Europe in other categories	South Korea	ZAGUAR	registered
IMPULSE MEDICAL TECHNOLOGIES, INC.	–	The Electrode Store MedCare Visions DPNCheck	registered
Mectron S.P.A. Present in Europe in other categories	Italy	MECTRON	registered
ALPHATEC SPINE, INC.	United States	SafeOp SafeOp 3 Arcus General Instruments Sigma	K252842 (2026)
Medos International Sàrl Present in Europe in other categories	Switzerland	SENTIO ORBIT GALAXY ORBIT GALAXY XTRASOFT	K220040 (2022)
MEDIMAX TECH INC.	–	MediMax Tech	registered
Dixi Medical	France	–	K202087 (2021)
W & H Dentalwerk Bürmoos GmbH Present in Europe in other categories	Austria	Piezomed Pro Accessory SpeedControl SC1 (M-UK1023) Piezomed Pro M-PH350 AMADEO M-UK1023 S-11 AMADEO M-UK1015	registered
Neuronetics, Inc.	United States	NeuroStar Advanced Therapy System TrakStar Patient Data Management System Software NeuroStar Headrest NeuroStar Head Support System, Domestic NeuroStar System Software NeuroStar TMS Therapy System	K231926 (2024)
Nox Medical ehf.	Iceland	Nox C1 Kit Nox C1 Access Point Nox A1 Starter Sensor Kit, Adult Nox A1 Starter Sensor Kit, Pediatric Nox A1® EEG 5 Lead Gold Electrode Cable Nox A1s System	K260585 (2026)
Biomet Orthopedics, LLC Present in Europe in other categories	United States	HAMMR™ CURVTEK CARTRIDGE CURVTEK EYE NEEDLE HALL STYLE MICRO-SAGITTAL Super MaxCutter™ X FIX	registered
Phasor Health, LLC	United States	PHASOR	K252060 (2025)
medical bees GmbH	Germany	Skull Pin pediatric Skull Pin adults MF head support system Connecting arm MF head support system table connection MF- Key of the table adapter Head support system with neck support	K250423 (2025)
Biosphere Medical, S.A. Present in Europe in other categories	France	Embosphere® QuadraSphere® QuadraSphere Q2™ EmboGold® EmboCube® Torpedo™	K250971 (2025)
Temena GmbH	United States	Temena	K990100 (2000)
Ambu A/S Present in Europe in other categories	Denmark	SleepmateCannuTherm Thermistor - Alice 3 SleepmateCannuTherm Thermocouple - 90 cm SleepmateThermistor AirFlow - 90 cm SleepmateResp. Effort System, Double Buckle - Cadwell Airflow Thermistor 78 inSleepmate SleepmateOne Channel Thermistor, Infant (Cable, Interface & 10 sensors	K093825 (2010)
MEDTRONIC PS MEDICAL, INC.	United States	Midas Rex MR8	registered
SONTEC INSTRUMENTS, INC.	United States	WIRE/PIN CUTTER WIRE END CUTTER PIN CUTTER WIRE CUTTER PARALLEL WIRE EXTRACTION PLIERS REPLACEMENT TUNGSTEN CARBIDE BLADES	registered
MOBERG RESEARCH INC	United States	Component Neuromonitoring System Component Monitoring System CNS Envision	K192572 (2019)
Noras Mri Products GmbH Present in Europe in other categories	Germany	NORAS OR HEAD COIL Top Array Siemens 3T OR Head Holder LUCY with HeadCoilSet Philips 3T OR Head Holder LUCY with HeadCoilSet Philips 1.5T Head Frame LUCY Base Plate Set Getinge A0, Getinge B0, Mizuho Tray for Operation Parts LUCY	registered
NEURALYNX, INC.	United States	ATLAS MICROMED JB INTERFACE ATLAS-HS-36-CHET-D18 ATLAS-HS-36-CHET-A9 ATLAS Cart BNC Adapter Plate Global Reference Module 4 Pegasus Software License 128ch	K110967 (2011)
NOVO SURGICAL, INC.	–	Novo Surgical Novosurgical Novo Surgical Inc. Novo Surgical Inc	registered
STERIS Corporation Present in Europe in other categories	United States	V. Mueller Snowden-Pencer	registered
Chalgren Enterprises, Inc.	United States	Chalgren	K982950 (1999)
GSOURCE LLC	United States	gSource	registered
TELEFLEX INCORPORATED Present in Europe in other categories	United States	KMEDIC PILLING OPTISPHERE GEL-BEAD GEL-BLOCK	registered
Embla Systems	Canada	Xltek Natus Embla Systems Embla	K180001 (2019)
PRECISION BIOMETRICS INC	United States	MyoVision Wirefree System MyoVision Software USB 2.0 Cable (WireFree) SERIES-5 MyoVision ScanVision Power Supply for WireFree Flexlite Charging Cable	K123399 (2013)
Avalign Technologies, Inc.	United States	Millennium Avalign	registered
Gyrus Acmi, Inc. Present in Europe in other categories	United States	DIEGO Diego Elite Gyrus ACMI Celeris	K212650 (2022)
MIZUHO CORPORATION Present in Europe in other categories	United States	Multipurpose Head Frame Radiolucent Head Frame Frame Unit Hand Rest L Table Attachment for 3080, Outside Cotton Plate Adjustor	K955012 (1996)
Micro-Aire Surgical Instruments, Inc. Present in Europe in other categories	United States	MicroAire®	K904949 (1990)
Conmed Corporation Present in Europe in other categories	United States	CONMED 24K Thorne Chuck ERGO ADVANTAGE POWERPRO	registered
AMBLER SURGICAL CORP.	–	Ambler Surgical Ambler Value Line	registered
Celonova Biosciences, Inc.	United States	Embozene Microspheres (Color-Advanced) Embozene Microspheres (Opaque) ONCOZENE Microspheres	K141209 (2014)
KOROS U.S.A., INC.	United States	Dilator Tube Set, Single Use, Sterile Nerve Stimulator Probe Anterior Distraction Screws Neuromonitoring Wire with Clip Disposable XL Dilator Tube Large Dilator Tube	registered
BLACKROCK MICROSYSTEMS, LLC	United States	Blackrock NeuroPort Biopotential Signal Processing System Digital NeuroPort Biopotential Signal Processing System NeuroPlex E128 Sterile NeuroPlex E128 NeuroPort Inserter Assembly NeuroPort Electrode (SIROF)	K202174 (2021)
NEUROELECTRICS BARCELONA SL	–	Enobio Dx	registered
NEUROSOFT, OOO	–	Neuro-IOM Focus MEGA-TMS Neuron-Spectrum Neuron-Spectrum-AM CloudTMS Edge	registered
Canyon Medical, Inc. Present in Europe in other categories	China	Polyvinyl Alcohol Embolic Microspheres	K250209 (2025)
Ge Medical Systems Information Technologies Present in Europe in other categories	United States	Portrait CSSXB Portrait CVAXB B125M CARESCAPE ONE B155M B105M	K962781 (1997)
Kirwan Surgical Products, Inc.	United States	Kirwan	K100912 (2010)
Acra Cut, Inc.	United States	Cranial Blade Disposable low speed Wire Pass Drill Disposable Cranial Perforator ACRA-CUT Acra-Cut Reusable Cranial Perforator	K032970 (2003)
PRO-DEX, INC.	United States	KLS E-Coupling Adapter Zimmer Biomet Straight Collet Atlas Pro Driver Battery Pack, Sterile Battery Pack, Single Use, PDCMF, Tadiran Matrix Pro II J-latch collet Matrix Pro II Driver	registered
A. Schweickhardt GmbH & Co. KG	–	SCHWERT	registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories	United States	Bovie Symmetry Surgical MOORE Symmetry Surgical HUDSON Symmetry Surgical Symmetry Hercules Symmetry Wire	registered
ELLIQUENCE, LLC Present in Europe in other categories	United States	Tungsten Carbide Burr Diamond Burr Surgi-Max Drill Support Tube Surgi-Max Drill System Angled Handpiece	registered
Cleveland Medical Devices, Inc.	United States	Premium Study Kit ReadyRip Belt SleepView Starter Kit Sapphire Study Kit SleepView	registered
Varian Medical Systems, Inc. Present in Europe in other categories	United States	ONCOZENE 40um Oncozene 3mL - US Embozene Color Advance 1300um Embozene 1mL Colored - US Embozene Color Advance 900um Embozene 1mL Colored - US Embozene Color Advance 40um Embozene 1mL Colored - US Embozene Color Advance 1300um Embozene 2mL Colored - US Embozene Color Advance 700um Embozene 1mL Colored - US	K242608 (2025)
Myotronics-Noromed, Inc.	United States	K7 Evaluation System-ESG MES 9000 Dynamic EMG K7 Evaluation System-CMS K7 Evaluation System-EMG Myotronics 6145 Duotrodes Norotrode 20	K003287 (2000)
BLACKROCK NEUROMED, LLC	United States	JB CERVELLO 32 CERVELLO 32 CERVELLO 32 W CERVELLO 64 W CERVELLO 64 JB CERVELLO 64	K122196 (2013)
Intelligent Hearing Systems Present in Europe in other categories	United States	Visual Stimulation Box Universal Smart Box SmartEP Software USB to Electrical Stimulation Box Cable Electrical Stimulator Probe Electrical Stimulation Box	K052060 (2005)
Med Saver, Inc.	–	MSI Precision Specialty Instruments	registered
Medidata Solutions, Inc.	–	BioStamp nPoint™ BioStamp® BioStamp® nPoint	registered
ORTHO-MED, INC.	United States	ORTHOMED	registered
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION	–	Sliding Suture Cutter Trim Cord Suture Cutter Knotless flush cutter Suture Cutter 2mm Suture cutter 2.0	registered
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.	United States	AED-SLT KIT AED-SLT PUMP AED-SLT DYONICS-STOP AED-SLT STRYKER SMALL JOINT-STOP AED-SLT MEDTRONIC-STOP AED-SLT CONMED LINVATEC-STOP	registered
Neuroone Medical Technologies Corp.	United States	EVO sEEG Electrode OneRF Ablation System EVO Cable Assembly	K222404 (2022)
Power Dental U.S.A. Inc.	United States	Power Dental USA Power Dental U.S.A., Inc.	registered
Edan Instruments, Inc. Present in Europe in other categories	China	Patient Monitor Telemetry Transmitter	registered
TECOMET INC.	United States	Tecomet	registered
Globus Medical, Inc. Present in Europe in other categories	United States	VERZERA	registered
Surgify Medical OY	Finland	Surgify Halo 5.4 mm 4.0 mm Long Extendable Short	K253627 (2026)
Zeto, Inc.	United States	Zeto ONE Display Unit Zeto ONE Head Unit - Regular Zeto ONE Head Unit - Small Zeto All-in-One Medical Grade PC Zeto Extension Unit Zeto TTL Extension Unit	K260455 (2026)
Gimmi GmbH Present in Europe in other categories	Netherlands	Gimmi	registered
Smith & Nephew, Inc. Present in Europe in other categories	United States	ACCURIS CHS TRIGEN VLP MINI-MOD Peri-loc	registered
Watermark Medical, Inc.	United States	ARES 610 Home Sleep Test Accessories - 10 pack ARES 620 Home Sleep Test Accessories - 10 pack ARES 620 Unicorder System ARES 610 Home Sleep Test Accessories - 50 Pack ARES620 Secure Sleep Test Accessories - 10 pack ARES 610 Unicorder System	K160499 (2017)
Aga Medical Corp.	United States	AMPLATZER™	K113658 (2012)
Devroye Instruments Belgium	Belgium	WAW HYBRID TORNADO PUNCH 1.05 WAW HYBRID TORNADO PUNCH 1.00 WAW HYBRID TORNADO PUNCH 1.10 WAW HYBRID TORNADO PUNCH 0.90 WAW HYBRID TORNADO PUNCH 1.20 WAW HYBRID TORNADO PUNCH 0.80	registered
HAPPY HEALTH, INC.	United States	Happy Health	K242224 (2025)
M F Equipamentos Medicos Ltda Epp	–	Neurovirtual	registered

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