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SOMNOtouch™ RESP eco
EUDAMEDClass IIa (EU MDR)
Ref TOR050-EModel SOMNOtouchRef TOR100-EModel SOMNOtouch RESP
Identity
- Trade Name
- SOMNOtouch™ RESP eco EUDAMEDSOMNOtouch RESP eco EUDAMED
- Model / Reference
- SOMNOtouch EUDAMEDTOR050-E EUDAMEDSOMNOtouch RESP EUDAMEDTOR100-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413404773 EUDAMED04250413404780 EUDAMED
- Basic UDI-DI
- 42504134PSGSC EUDAMED42504134SOMNOtouchRESPZS EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
SOMNOtouch™ RESP eco 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 | 42504134PSGSC | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 06408eca-6d14-4721-b6f4-d9b870dd3ea8 61 fields · synced Jun 20, 2026
- EUDAMED e5107a68-dd0d-4de8-8942-d1be6fd7c958 61 fields · synced Jun 20, 2026