Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsPeripheral or central neuro stimulation and assessment instruments
Peripheral or central neuro stimulation and assessment instruments - consumables
EMDN code Z12101185
Manufacturers registered in Europe (EUDAMED) 9
- 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.
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) 48
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 |
|---|---|---|---|
| Technomed Engineering B.V. | – | Technomed Europe Cadwell Neurosign V4 Neuroguard Natus Neuroradium | registered |
| Rhythmlink International, LLC Present in Europe in other categories | United States | Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC Rhythmlink | K200984 (2020) |
| Xi'an Friendship Medical Electronics Co.,Ltd. Present in Europe in other categories | China | Friendship Medical Cadwell Natus | registered |
| 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 |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | NATUS NEUROLOGY Natus | registered |
| Temena GmbH | United States | Temena | K990100 (2000) |
| ALPHATEC SPINE, INC. | United States | SafeOp SafeOp 3 | registered |
| 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) |
| 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 |
| Chalgren Enterprises, Inc. | United States | Chalgren | K896370 (1989) |
| NATUS MANUFACTURING LIMITED Present in Europe in other categories | Ireland | Grass | registered |
| SGM d.o.o. | – | Corkscrew Electrode Corkscew Electrode | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | AVS ARIA | registered |
| Kego Corporation | Canada | KING Disposable Subdermal Corkscrew Needle Electrode | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| ALPHATEC HOLDINGS, INC. | United States | – | registered |
| Arrow International LLC (subsidiary of Teleflex Incorporated Present in Europe in other categories | United States | – | registered |
| Bionen S.A.S. Present in Europe in other categories | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Daehan Medical Systems Co., Ltd. | South Korea | – | K161566 (2016) |
| Euclide Care | France | – | registered |
| Gereonics, Inc. | United States | – | registered |
| Ives Eeg Solutions, Inc. | Canada | – | K062880 (2006) |
| Lincotek Medical LLC Present in Europe in other categories | United States | – | registered |
| MacKay Manufacturing, Inc. | United States | – | registered |
| Natus Medical Incorporated Present in Europe in other categories | United States | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| Remington Medical, Inc. | United States | – | registered |
| Rhenus SE & Co. KG | Germany | – | registered |
| SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI | Türkiye | – | registered |
| SHENZHEN LAUNCH ELECTRICAL CO., LTD Present in Europe in other categories | China | – | registered |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| SteriPack Medical Poland Sp. z o.o. | Poland | – | registered |
| Suzhou Haishen Medical Device Associates Co., Ltd. Present in Europe in other categories | China | – | K232581 (2023) |
| TEDAN SURGICAL INNOVATIONS, L.L.C. Present in Europe in other categories | United States | – | K231691 (2023) |
| THE CRETEX COMPANIES, INC. | United States | – | registered |
| The Electrode Store, Inc. | United States | – | K020910 (2002) |
| VEENAK INTERNATIONAL LIMITED | United Kingdom | – | registered |
| VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. | Türkiye | – | registered |
| sfm medical devices GmbH | Germany | – | registered |
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