← Back to catalogue
SOMNOwatch plus ACTI + 1 channel EEG
EUDAMEDClass IIa (EU MDR)
Ref SOWP340Model SOMNOwatch plus
Identity
- Trade Name
- SOMNOwatch plus ACTI + 1 channel EEG EUDAMED
- Model / Reference
- SOMNOwatch plus EUDAMEDSOWP340 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406135 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 EEG 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 5cb44117-5161-4822-9153-42a14989d7aa 61 fields · synced Jul 29, 2026