Manufacturer
Sibel Health
United StatesLegal entities : Sibel Health Inc.
Markets : Germany · United States
Approvals : EU – class IIb · United States (FDA) – 510(k) : 5 · class I, II · latest in 2026 · see on the FDA website
EU representative : MDSS 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 |
|---|---|---|---|---|
| Multi-parameter monitors - hardware accessories | Z1203020280 | IIb MDR | EUDAMED record Report an error |
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