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SOMNOwatch plus ACTI + 1 channel ECG
EUDAMEDClass IIa (EU MDR)
Ref SOWP330Model SOMNOwatch plus
Identity
- Trade Name
- SOMNOwatch plus ACTI + 1 channel ECG EUDAMED
- Model / Reference
- SOMNOwatch plus EUDAMEDSOWP330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406128 EUDAMED
- Basic UDI-DI
- 42504134SOMNOwatchplusAK EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The SOMNOwatch™ plus is a portable, miniaturized multi-channel measuring system for recording physiological signals on an outpatient basis. The SOMNOwatch™ plus helps the doctor to diagnose sleep disorders. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
SOMNOwatch plus ACTI + 1 channel ECG by SOMNOmedics AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504134SOMNOwatchplusAK | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 90ef08ba-43aa-4d04-beb4-0942e8cc0ee1 61 fields · synced Jul 21, 2026