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SOMNOFIT Mandibular advancement device
EUDAMEDClass I (EU MDR)
Ref S-02Model Mandibular Advancement devices
by Oscimed SA
Identity
- Trade Name
- SOMNOFIT Mandibular advancement device EUDAMED
- Device Name
- Mandibular advancement devices EUDAMED
- Model / Reference
- Mandibular Advancement devices EUDAMEDS-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640104927006 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
- France 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 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 |
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Manufacturer
- Manufacturer
- Oscimed SA
- EUDAMED SRN
- CH-MF-000009605
- Authorised Representative
- OSCIMED EUROPE SAS FR-AR-000028943
Sources (1)
- EUDAMED 2175bfe6-d7ea-48fa-8596-2bece2cb1f0d 61 fields · synced Jun 18, 2026