Manufacturer
Sleepiz
SwitzerlandLegal entities : Sleepiz AG
Markets : Germany · United States
Approvals : EU – class IIa · United States (FDA) – 510(k) : 3 · class II · latest in 2026 · see on the FDA website
EU representative : MED-RAS GmbH Regulatory Affairs Service (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 |
|---|---|---|---|---|
| Vital signs monitoring instruments - hardware accessories | Z12030280 | IIa MDR | EUDAMED record Report an error | |
| Multi-disciplinary telemetry systems | Z129011 | IIa MDR | EUDAMED record Report an error | |
| Vital signs monitoring instruments - medical device software | Z12030292 | IIa MDR | EUDAMED record Report an error | |
| Vital signs monitoring instruments - software accessories | Z12030282 | IIa MDR | EUDAMED record Report an error |
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