Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instruments
Nervous system monitoring systems
EMDN code Z121002
Manufacturers registered in Europe (EUDAMED) 14
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 181
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 |
|---|---|---|---|
| Nuvasive, Inc. Present in Europe in other categories | United States | ReLine PULSE MaXcess NVM5 Armada MAS PLIF | K112717 (2012) |
| Technomed Engineering B.V. | – | Neurosign V4 Technomed Europe Neuroradium Inomed Cadwell Neuroguard | registered |
| Rhythmlink International, LLC Present in Europe in other categories | United States | Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC Rhythmlink | K200984 (2020) |
| Neurovision Medical Products, Inc. Present in Europe in other categories | United States | Dragonfly® Nerveana® Nerveana+® Nerveäna+® Nerveana | K121931 (2012) |
| 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) |
| Spes Medica Srl Present in Europe in other categories | Italy | IOM Stimulator Probes Dragonfly Laryngeal Surface Electrodes Spes Medica Subdermal Needle Electrodes | K192603 (2019) |
| LifeSync Corporation | United States | Horizon™ Rochester SurePoint™ | registered |
| IMPULSE MEDICAL TECHNOLOGIES, INC. | – | The Electrode Store MedCare Visions DPNCheck | registered |
| ALPHATEC SPINE, INC. | United States | SafeOp SafeOp 3 Arcus General Instruments Sigma | registered |
| Bio Protech, Inc. Present in Europe in other categories | United States | Bio Protech PROEMG | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | ULTRA-DRIVE TOOL Ultra-Drive® Tool ULTRA DRIVE III HANDPIECE ULTRA DRIVE III CONSOLE ULTRA DRIVE IRRIGATION ULTRA-DRIVE® | registered |
| MEDIMAX TECH INC. | – | MediMax Tech | registered |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | NATUS NEUROLOGY Natus | registered |
| Temena GmbH | United States | Temena | K990100 (2000) |
| Ambu A/S Present in Europe in other categories | Denmark | Neuroline MonopolarNeurology Needle Electrodes Ambu Subdermal CorkscrewSingle Patient Probes Ambu Bipolar ProbeSingle Patient Probes Ambu Monopolar ProbeSingle Patient Probes 202257-000 Needle, Mono Kit Ambu CA CE Ambu Concentric ProbeSingle Patient Probes | K071185 (2007) |
| Kirwan Surgical Products, Inc. | United States | Kirwan | K100912 (2010) |
| Spineguard S.A. Present in Europe in other categories | France | PediGuard DSG Connect CANNULATED PEDIGUARD PEDIGUARD CLASSIC PEDIGUARD CURV PEDIGUARD CLASSIC | registered |
| Diopsys, Inc. Present in Europe in other categories | United States | Diopsys® | K101763 (2011) |
| 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 |
| Lkc Technologies, Inc. | United States | RETeval™ UTAS | K142567 (2015) |
| Ad-Tech Medical Instrument Corporation Present in Europe in other categories | United States | FREMAP Electrode Spinal Electrode Kit | K152769 (2016) |
| STRYKER CORPORATION Present in Europe in other categories | United States | ES2 SPINAL SYSTEM AVS ARIA | K140400 (2014) |
| Chalgren Enterprises, Inc. | United States | Chalgren | K923665 (1992) |
| Medos International Sàrl Present in Europe in other categories | Switzerland | SENTIO | registered |
| Roland Consult Stasche & Finger GmbH Present in Europe in other categories | – | RETI-port/scan 21 alpha plus RETI-port/scan 21 beta plus RETI-port/scan 21 alpha RETI-port/scan 21 delta plus RETI-port/scan 21 gamma plus RETI-port/scan 21 gamma | registered |
| Checkpoint Surgical, Inc. Present in Europe in other categories | United States | Guardian Intraoperative Lead, Medium Checkpoint Gemini Checkpoint Head & Neck Guardian Intraoperative Lead, Small Guardian Probe Extension, 12 cm Guardian Probe Extension, 4 cm | K212355 (2021) |
| HAPPY HEALTH, INC. | United States | Happy Health | registered |
| Impeto Medical Present in Europe in other categories | United States | SUDOSCAN | K141872 (2014) |
| 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 | registered |
| Wr Medical Electronics Co. Present in Europe in other categories | United States | Surgical Probe Monopolar Silverstein Facial Nerve Stimulator Remote Probe Hilger Dual Stim Surgical Probe, Monopolar w/Protected Plug Hilger Dual-Stimulator Remote Probe Silverstein Facial Nerve Stimulator | K063560 (2007) |
| Allotrope Medical Inc. | United States | StimSite | K200886 (2020) |
| NATUS MANUFACTURING LIMITED Present in Europe in other categories | Ireland | Grass | registered |
| MICROMED SPA Present in Europe in other categories | United States | Micromed | K211974 (2021) |
| QX WORLD LTD | Hungary | QUEX S QUEX ED | registered |
| SGM d.o.o. | – | Corkscrew Electrode Corkscew Electrode | registered |
| XLTEK | Canada | Natus | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Bovie | registered |
| INVOTEC INTERNATIONAL, INC. | United States | Invotec Single Channel Electrode Invotec Dual Channel Electrode | K122040 (2013) |
| Intelligent Hearing Systems Present in Europe in other categories | United States | Visual Stimulation Box Universal Smart Box SmartEP Software | registered |
| Kego Corporation | Canada | KING Disposable Subdermal Corkscrew Needle Electrode | registered |
| Laborie Medical Technologies Canada ULC | – | Dorado KT Cart with Evox (120V) Aquarius TT with Evox Dorado KT Cart with Evox (240V) | registered |
| Northgate Technologies, Inc. | United States | StimSite Signal Box StimSite AM-VY1 Adapter StimSite Activation Card | registered |
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K933491 (1993) |
| Ld Technology, LLC Present in Europe in other categories | United States | ANS1 Software SweatC | K152216 (2015) |
| Lifelines , Ltd. Present in Europe in other categories | United Kingdom | Lifelines Photic Stimulator | K101691 (2010) |
| METROVISION Present in Europe in other categories | France | Vision Monitor - MonCvONE Vision Monitor - MonPackONE | K212936 (2022) |
| NEUROSOFT, OOO | – | Neuro-IOM Focus | registered |
| Neo Medical SA | Switzerland | NeuroTrace | registered |
| SPINAL ELEMENTS, INC. | United States | IO-FLEX | registered |
| SpineArt SA Present in Europe in other categories | Switzerland | OTELO INSTRUMENTATION | registered |
| ANSCHEL TECHNOLOGY INC. | United States | SightSaverMini | K113785 (2012) |
| BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETI | – | Bioscope Neuromonitor Device | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Epineuron Technologies Inc. | Canada | Evala nerve stimulator | K253536 (2026) |
| FREMSLIFE SRL | – | FREMSLIFE | registered |
| ITOVI, LLC | – | iTOVi | registered |
| International Health Tech | United States | BioScan | registered |
| KONAN MEDICAL USA, INC. Present in Europe in other categories | Japan | – | registered |
| Medeia, Inc. Present in Europe in other categories | United States | SudoCheck | K150804 (2015) |
| NEUROTRON MEDICAL, INC. | United States | Brevio | K012069 (2001) |
| Pacira Pharmaceuticals, Inc. | United States | iovera Smart Tip | registered |
| WITHINGS Present in Europe in other categories | France | Withings® | registered |
| Zyto Technologies, Inc. | United States | ZYTO Hand Cradle | K111308 (2011) |
| AD Supply Group Limited | United Kingdom | – | registered |
| ADM TRONICS UNLIMITED, INC. | United States | – | registered |
| ALPHATEC HOLDINGS, INC. | United States | – | registered |
| ARCH Medical Solutions - Olive Branch | United States | – | registered |
| ARCH Medical Solutions - Seabrook | United States | – | registered |
| ATL Technology LLC | United States | – | registered |
| Arch Medical Solutions | United States | – | registered |
| Ardiem Medical, inc. | United States | – | registered |
| Arrow International LLC (subsidiary of Teleflex Incorporated Present in Europe in other categories | United States | – | registered |
| Avalign Delivery Systems Division | United States | – | registered |
| Avalign Instruments & Implants | United States | – | registered |
| BEE Medic GmbH Present in Europe in other categories | Germany | – | registered |
| BEYONICS INTERNATIONAL PTE. LTD. | Singapore | – | registered |
| BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRK | Türkiye | – | registered |
| Betts Precision | United States | – | registered |
| Bionen S.A.S. Present in Europe in other categories | United States | – | registered |
| Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | Türkiye | – | K233001 (2024) |
| Bradshaw Medical, Inc. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COMPUMEDICS LIMITED Present in Europe in other categories | Australia | – | registered |
| Canadian Hospital Specialties Limited | Canada | – | registered |
| Chemigraphic Ltd | United Kingdom | – | registered |
| Cirtec Medical Corporation | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Cryptych Pty, Ltd. | Australia | – | K200705 (2020) |
| Culver Tool & Engineering LLC dba SpiTrex CTE | United States | – | registered |
| Daehan Medical Systems Co., Ltd. | South Korea | – | K161566 (2016) |
| Demcon Production B.V. | Netherlands | – | registered |
| Ducommun LaBarge Technologies | United States | – | registered |
| ELMED INCORPORATED | United States | – | registered |
| EVER PPE INC | United States | – | registered |
| Engineered Medical Systems | United States | – | registered |
| Engineering CPR Inc. | Canada | – | registered |
| Euclide Care | France | – | registered |
| Exxelia Micropen | United States | – | registered |
| FIBEROPTICS TECHNOLOGY, INC. | United States | – | registered |
| FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD | China | – | registered |
The 100 most active manufacturers are shown, out of 181.
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