Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsPolysomnography instruments
Polysomnography instruments - hardware accessories
EMDN code Z12100580
Manufacturers registered in Europe (EUDAMED) 12
- 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) 9
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 |
|---|---|---|---|
| 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 | registered |
| Myotronics-Noromed, Inc. | United States | K7 Evaluation System-ESG MES 9000 Dynamic EMG K7 Evaluation System-CMS MES 9000 Muscle Tester K7 Evaluation System-EMG Monotrode 101 | K003287 (2000) |
| Bio-Research Associates, Inc. | United States | M-Scan BioPAK BioEMG | K130158 (2013) |
| HHS SYSTEMS, INC. | United States | HindexRV | registered |
| BTS SPA Present in Europe in other categories | Italy | TEETHAN | K161716 (2016) |
| Bioresearch | United States | – | registered |
| Electronic Waveform Laboratory, Inc. | United States | – | K862121 (1987) |
| Innokas Yhtyma Oy Present in Europe in other categories | Finland | – | registered |
| JIANGYIN SINBON ELECTRONICS CO LTD | China | – | registered |
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