Identity
- Trade Name
- SANABRUX EUDAMED
- Device Name
- Dental protector for bruxism EUDAMED
- Model / Reference
- Bruxism devices EUDAMEDS-BRX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640104927501 EUDAMED
- Basic UDI-DI
- 764010492DENTALPROTECT2Z EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Sanabrux 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 | 764010492DENTALPROTECT2Z | 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 bde5f764-8a60-46d6-96eb-786e67c0541c 61 fields · synced Jun 18, 2026