← Back to catalogue
Application Mount SOMNOtouch RESP
EUDAMEDClass I (EU MDR)
Ref TOS811Model Mounting belt
Identity
- Trade Name
- Application Mount SOMNOtouch RESP EUDAMED
- Model / Reference
- Mounting belt EUDAMEDTOS811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413404230 EUDAMED
- Basic UDI-DI
- 42504134Gurt-AHA6 EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Application 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 (1)
- EUDAMED 3ec74310-a3cc-46ac-89dc-0decd7f1c8e1 61 fields · synced Jul 15, 2026