Identity
- Trade Name
- SOMNOscreen™ plus EUDAMEDSOMNOscreen plus FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- SOMNOscreen EUDAMEDSSP704 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SSP704 FDA UDI
- Primary DI / UDI-DI
- 04250413400195 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134SSCPKB EUDAMED
- 510(k) Number
- K081485 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
SOMNOscreen™ plus by SOMNOmedics AG — Class IIa — 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 | 42504134SSCPKB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED be6e460b-faca-4157-8a81-42a6a2968b5e 61 fields · synced Jul 11, 2026
- FDA UDI 0c40c4ef-c1ef-4e24-bbc1-8839daae1f55 34 fields · synced May 29, 2026