← Back to catalogue
SOMNOFIT-B Mandibular advancement device
EUDAMEDClass I (EU MDR)
Ref S-05Model Mandibular Advancement devices
by Oscimed SA
Identity
- Trade Name
- SOMNOFIT-B Mandibular advancement device EUDAMED
- Device Name
- Mandibular advancement devices EUDAMED
- Model / Reference
- Mandibular Advancement devices EUDAMEDS-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640104927037 EUDAMED
- Basic UDI-DI
- 764010492SOMNOFIT8U EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER 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
SOMNOFIT-B Mandibular advancement device by Oscimed SA — 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 | 764010492SOMNOFIT8U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oscimed SA
- EUDAMED SRN
- CH-MF-000009605
- Authorised Representative
- OSCIMED EUROPE SAS FR-AR-000028943
Sources (1)
- EUDAMED 154eba3d-6dd4-4eec-b4eb-9a7747d05b88 61 fields · synced Aug 4, 2026