← Back to catalogue
SOMNOwatch plus Dockingstation
EUDAMEDFDA UDIClass I (EU MDR)
Ref SOW106Model Docking station
Identity
- Trade Name
- SOMNOwatch plus Dockingstation EUDAMEDSOMNOwatch plus Docking Station FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Model / Reference
- Docking station EUDAMEDSOW106 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413401666 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134DS-SOW7V EUDAMED
- 510(k) Number
- K081485 FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
SOMNOwatch plus Dockingstation by SOMNOmedics AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504134DS-SOW7V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 8fe708a7-881e-4f42-8af6-3dcf9f35853e 61 fields · synced Jun 18, 2026
- FDA UDI 750817e0-517c-4401-ae79-44368f5e9e05 33 fields · synced May 30, 2026