← Back to catalogue
Body Mount SOMNOtouch RESP
EUDAMEDClass I (EU MDR)
Ref TOS810Model Mounting beltRef TOR110RModel SOMNOtouch RESP
Identity
- Trade Name
- Body Mount SOMNOtouch RESP EUDAMEDSOMNOtouch RESP EUDAMED
- Model / Reference
- Mounting belt EUDAMEDTOS810 EUDAMEDSOMNOtouch RESP EUDAMEDTOR110R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413404285 EUDAMED04250413407194 EUDAMED
- Basic UDI-DI
- 42504134Gurt-AHA6 EUDAMED42504134SOMNOtouchRESPZS EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDZ12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Body Mount SOMNOtouch RESP by SOMNOmedics AG — Class I — 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 | 42504134Gurt-AHA6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 11c07ee3-d419-40e0-a88d-dacdaa652b55 61 fields · synced Aug 4, 2026
- EUDAMED ef74978d-35e2-455f-884c-c5df0ac6fad1 61 fields · synced Jul 17, 2026