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SOMNOwatch™ eco blue
EUDAMEDClass IIa (EU MDR)
Ref SOWE050-BModel SOMNOwatchRef SOWE200Model SOMNOwatch eco
Identity
- Trade Name
- SOMNOwatch™ eco blue EUDAMEDSOMNOwatch eco Blue EUDAMED
- Model / Reference
- SOMNOwatch EUDAMEDSOWE050-B EUDAMEDSOMNOwatch eco EUDAMEDSOWE200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406364 EUDAMED04250413406418 EUDAMED
- Basic UDI-DI
- 42504134SOWPLK EUDAMED42504134SOMNOwatcheco9A EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SOMNOwatch™ eco blue 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 | 42504134SOWPLK | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED e9be7dbe-abe2-4850-8c17-51490d1deae4 61 fields · synced Jul 25, 2026
- EUDAMED 39e82340-1e7f-431b-aa4c-6a2b76d710ee 61 fields · synced Jul 25, 2026