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Add-on device: SOMNOtouch™ PSG ambulatory (R&K)
EUDAMEDClass IIa (EU MDR)
Ref TOR191AModel SOMNOtouch RESP
Identity
- Trade Name
- Add-on device: SOMNOtouch™ PSG ambulatory (R&K) EUDAMED
- Model / Reference
- SOMNOtouch RESP EUDAMEDTOR191A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413405343 EUDAMED
- Basic UDI-DI
- 42504134SOMNOtouchRESPZS EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The SOMNOtouch™ RESP is a portable device for recording physiological signals, which serves the physician as a Polygraphy (PG) or Polysomnography (PSG) system to assist in the diagnosis of sleep disorders. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Add-on device: SOMNOtouch™ PSG ambulatory (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 | 42504134SOMNOtouchRESPZS | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED fb3d5b5d-6786-43d9-9e74-95f97c5c069f 61 fields · synced Jul 22, 2026