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Add-on device: SOMNOtouch PSG ambulatory (AASM)
EUDAMEDClass IIa (EU MDR)
Ref TOR190AModel SOMNOtouch RESP
Identity
- Trade Name
- Add-on device: SOMNOtouch PSG ambulatory (AASM) EUDAMED
- Model / Reference
- SOMNOtouch RESP EUDAMEDTOR190A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413405336 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 (AASM) 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 8e885125-b5c2-45f9-ac14-40bb22304717 61 fields · synced Jul 30, 2026