Manufacturer
Neurotronics
United StatesLegal entities : Neurotronics, LLC
Markets : Germany · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 11 · class II · latest in 2026 · see on the FDA website
EU representative : NIHON KOHDEN EUROPE GmbH (Germany)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Polysomnography instruments - hardware accessories | Z12100580 | I MDR | EUDAMED record Report an error | |
| Polysomnography instruments - medical device software | Z12100592 | IIa 93/42 | EUDAMED record Report an error | |
| Polysomnographs | Z12100501 |
|
IIa 93/42 | EUDAMED record Report an error |
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