Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instruments
Peripheral or central neuro stimulation and assessment instruments
EMDN code Z121011
Manufacturers registered in Europe (EUDAMED) 43
- 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.
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Other manufacturers known in the United States (FDA) 124
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 |
|---|---|---|---|
| PMT CORPORATION | United States | DEPTHALON® DEPTHALON ACCUNAV® PMT® CORPORATION - SPHENOIDAL sEEG DEPTHALON® sEEG DEPTHALON | K151790 (2016) |
| Alpha Omega Engineering , Ltd. Present in Europe in other categories | Israel | NeuroProbe Sterile electrode's cable Cannula Sterile LeadConfirm Sterile neuroprobe Sterile cannula | K250601 (2025) |
| Technomed Engineering B.V. | – | Technomed Europe Cadwell Neurosign V4 Neuroguard Natus Neuroradium | registered |
| Ad-Tech Medical Instrument Corporation Present in Europe in other categories | United States | Spencer Probe Depth Electrode Macro Depth Electrode Sphenoidal Electrode Set Anchor Bolt Kit, LSB Style Depth Electrode Spinal Electrode Kit | K223269 (2023) |
| Xi'an Friendship Medical Electronics Co.,Ltd. Present in Europe in other categories | China | Friendship Medical Cadwell Natus | registered |
| Dixi Medical | France | – | K202087 (2021) |
| 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) |
| LifeSync Corporation | United States | Horizon™ Rochester SurePoint™ | registered |
| Spes Medica Srl Present in Europe in other categories | Italy | Spes Medica Subdermal Needle Electrodes | K192603 (2019) |
| Bio Protech, Inc. Present in Europe in other categories | United States | Bio Protech PROEMG | registered |
| IMPULSE MEDICAL TECHNOLOGIES, INC. | – | The Electrode Store MedCare Visions | registered |
| Neurovision Medical Products, Inc. Present in Europe in other categories | United States | Nerveana® Dragonfly® Nerveana+® Nerveäna+® Cobra® | registered |
| MEDIMAX TECH INC. | – | MediMax Tech | registered |
| Temena GmbH | United States | Temena | K990100 (2000) |
| ALPHATEC SPINE, INC. | United States | SafeOp SafeOp 3 | registered |
| Neuroone Medical Technologies Corp. | United States | EVO sEEG Electrode OneRF Ablation System EVO Cable Assembly | K222404 (2022) |
| 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) |
| Control Solutions, Inc. | United States | CS6101 Interferential Kit CS6101-2 Interferential Stimulator CS3101-TL2 Interferential Stimulator Leadwire Set for CS6101 Stimulator CS6101-1 Interferential Stimulator CS6101-3 Interferential Stimulator | registered |
| 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 |
| NEUROSOFT, OOO | – | CloudTMS Edge Neurosoft CloudTMS CloudTMS for OCD CloudTMS Edge for OCD CoudTMS Edge for OCD | registered |
| BLACKROCK MICROSYSTEMS, LLC | United States | NeuroPort Inserter Assembly NeuroPort Electrode (SIROF) NeuroPort Electrode NeuroPort Array Assembly | K110010 (2011) |
| Shenzhen Yingzhi Technology Co.,Ltd. | – | Ultimate rTMS TMS Coil Cooler Trolley | registered |
| Shenzhen roundwhale technology co. LTD. Present in Europe in other categories | China | ROOVJOY | registered |
| Chalgren Enterprises, Inc. | United States | Chalgren | K896370 (1989) |
| Neuroqore, Inc. | United States | NQ TMS Applicator Arm NQ TMS Applicator NQ TMS NQ TMS Coil Cooler | K232688 (2023) |
| SGM d.o.o. | – | Corkscrew Electrode Corkscew Electrode | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | AVS ARIA | registered |
| Diros Technology, Inc. Present in Europe in other categories | Canada | OWL | registered |
| Kego Corporation | Canada | KING Disposable Subdermal Corkscrew Needle Electrode | registered |
| Magnus Medical, Inc. | United States | SAINT | K220177 (2022) |
| OWEN MUMFORD USA INCORPORATED Present in Europe in other categories | United Kingdom | Neuropen Neuropen Monofilaments 10g Neurotips | registered |
| AXIOBIONICS | United States | EMPI Continuum OOFS Pace XL Stimulator | registered |
| DARCO INTERNATIONAL, INC. Present in Europe in other categories | United States | DARCO® Foot Filament DARCO® Monofilament Tester | registered |
| Fotona D.O.O. Present in Europe in other categories | Slovenia | QuantumStar, StarFormer StarFormer | K241785 (2025) |
| MEDIPIN LIMITED | United Kingdom | Medipin | registered |
| Neuromodulatory Devices & Applications | United States | Ampa One System | K251210 (2025) |
| BAILEY INSTRUMENTS LTD | United Kingdom | Bailey Retractable Monofilament 10g | registered |
| Inmode MD , Ltd. | Israel | Tone Applicator | registered |
| YOSTRA LABS PRIVATE LIMITED | India | NEURO TOUCH | registered |
| Zeta Surgical, Inc. | United States | Zeta TMS Navigation System | K261471 (2026) |
| 15445361 Canada Inc. | Canada | – | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| ALIMED, INC. | United States | – | registered |
| ALPHATEC HOLDINGS, INC. | United States | – | registered |
| AMC GLOBAL (CAMBODIA) CO., LTD | Cambodia | – | registered |
| Arrow International LLC (subsidiary of Teleflex Incorporated Present in Europe in other categories | United States | – | registered |
| Asp Global, LLC | United States | – | registered |
| BTL Industries FZE | United Arab Emirates | – | registered |
| Beijing Sinovation Medical Technology Co., Ltd. | China | – | K250363 (2025) |
| Bionen S.A.S. Present in Europe in other categories | United States | – | registered |
| Brain Science Tools B.V. | Netherlands | – | registered |
| Brain Ultimate, Inc. | United States | – | K261228 (2026) |
| Brainways , Ltd. | Israel | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Cirtec Medical Corporation | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| D&K Engineering | United States | – | registered |
| DOMICO MED-DEVICE, LLC | United States | – | registered |
| Daehan Medical Systems Co., Ltd. | South Korea | – | K161566 (2016) |
| Dongguan KIO Electronic Materials Co., Ltd | China | – | registered |
| Eemagine Medical Imaging Solutions GmbH Present in Europe in other categories | Germany | – | registered |
| Euclide Care | France | – | registered |
| FABRICATION ENT., INC. | United States | – | registered |
| FISHER-WALLACE LABORATORIES Inc | United States | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Fidelity BioPharma Co. | United States | – | K260396 (2026) |
| Gereonics, Inc. | United States | – | registered |
| Guangzhou Goldsun Electronic CO. Ltd | China | – | registered |
| HOBIAN S.R.L. | Romania | – | registered |
| Ice Neurosystems, Inc. | United States | – | K222706 (2022) |
| Innopex Limited | Canada | – | registered |
| Innovative Medical Manufacturing Co. | United States | – | registered |
| Ives Eeg Solutions, Inc. | Canada | – | K062880 (2006) |
| Lincotek Medical LLC Present in Europe in other categories | United States | – | registered |
| MIZRA MEDICAL LTD. | Israel | – | registered |
| MacKay Manufacturing, Inc. | United States | – | registered |
| MagVenture A/S | Denmark | – | registered |
| Makromed, Inc. | United States | – | registered |
| Mastars Industries CO., LTD | China | – | registered |
| Medical Monofilament Manufacturing | United States | – | K143068 (2015) |
| Microprobes For Life Science, Inc. Dba Neuron | United States | – | K162459 (2017) |
| Molex, Inc. | United States | – | registered |
| NEUROMODULATORY DEVICES & APPLICATIONS (NMDA), INC | United States | – | registered |
| NORTH COAST MEDICAL, INC. Present in Europe in other categories | United States | – | registered |
| Neuralace Medical, Inc. | United States | – | K233364 (2024) |
| Neurosoft, Inc. | United States | – | registered |
| NingBo Castle Medical Import & Export Co.,Ltd | China | – | registered |
| NingBo NingYuan Import&Export Co.,Ltd. | China | – | registered |
| ORTA MEDICAL LTD | Israel | – | registered |
| One Life Sciences, Inc. | United States | – | registered |
| Paul E. Danchell A/S | Denmark | – | registered |
| Perfect Group Corp. Ltd. | China | – | registered |
| Performance Health Supply Present in Europe in other categories | United States | – | registered |
| Precera Medical Inc | United States | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| QXMedical, LLC | United States | – | registered |
| RICHARDSON PRODUCTS, INC. | United States | – | registered |
| RUIAN SUNNYWORLD INTERNATIONAL TRADE CO.,LTD Present in Europe in other categories | China | – | registered |
| Remington Medical, Inc. | United States | – | registered |
The 100 most active manufacturers are shown, out of 124.
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