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SOMNOscreen plus PSG+ Tele (BT) R&K
EUDAMEDClass IIa (EU MDR)
Ref SBT202Model SOMNOscreen plus
Identity
- Trade Name
- SOMNOscreen plus PSG+ Tele (BT) R&K EUDAMED
- Model / Reference
- SOMNOscreen plus EUDAMEDSBT202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413409013 EUDAMED
- Basic UDI-DI
- 42504134SOMNOscreenplusEQ EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The SOMNOscreen™ plus is a portable device for continuous recording of physiological signals. It can serve the physician as a polysomnography (PSG) system to assist in the diagnosis of sleep disorders. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
SOMNOscreen plus PSG+ Tele (BT) R&K 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 | 42504134SOMNOscreenplusEQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 3beb3d00-dda4-43d1-b4d8-ea5a2e81621f 61 fields · synced Jun 19, 2026