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 - hardware accessories
EMDN code Z12101180
Manufacturers registered in Europe (EUDAMED) 11
- 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) 20
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 |
|---|---|---|---|
| Neuronetics, Inc. | United States | NeuroStar Advanced Therapy System TrakStar Patient Data Management System Software NeuroStar Headrest SenStar Treatment Link NeuroStar System Software SenStar Connect Treatment Link | K231350 (2023) |
| NEUROSOFT, OOO | – | CloudTMS for OCD CloudTMS Edge for OCD CoudTMS Edge for OCD CloudTMS | registered |
| Brainsway , Ltd. Present in Europe in other categories | Israel | Deep Transcranial Magnetic Stimulation (DTMS) System | K183303 (2019) |
| Mag & More GmbH Present in Europe in other categories | Germany | Apollo Light TMS Therapy System Apollo TMS Therapy System Apollo TMS Pro | registered |
| Nexstim Oyj Present in Europe in other categories | Finland | Nexstim NBS System | registered |
| BTL Industries, Inc. Present in Europe in other categories | United States | – | K230657 (2024) |
| Brain Ultimate, Inc. | United States | – | K243459 (2025) |
| Brainways , Ltd. | Israel | – | registered |
| D&K Engineering | United States | – | registered |
| DOMICO MED-DEVICE, LLC | United States | – | registered |
| MagVenture A/S | Denmark | – | registered |
| Mastars Industries CO., LTD | China | – | registered |
| Molex, Inc. | United States | – | registered |
| Neurosoft, Inc. | United States | – | registered |
| Nexstim Plc Present in Europe in other categories | Finland | – | registered |
| Shenzhen Yingchi Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Spartronics Strongsville Inc. | United States | – | registered |
| Teleemg, LLC | United States | – | K233742 (2023) |
| The Magstim Company , Ltd. Present in Europe in other categories | United Kingdom | – | registered |
| yiwu inwell craft&gift co.,ltd | China | – | registered |
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