Identity
- Trade Name
- SET ORL EUDAMED
- Device Name
- Assemblage ORL-ODONTOLOGIE STE EUDAMED
- Model / Reference
- 9544_1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661379253625 EUDAMED
- Basic UDI-DI
- 3661379ASS27ORL2ARV EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Les assemblages de la gamme ‘ORL – Odontologie’ sont destinés à : Être utilisés pour la prise en charge des soins dentaires et de la sphère ORL. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Set Orl by Hemodia Sas — Class IIa — 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 | 3661379ASS27ORL2ARV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemodia Sas
- EUDAMED SRN
- FR-PR-000007189
Sources (1)
- EUDAMED a62e2246-1925-44f1-8388-b1a378e1f3b3 61 fields · synced Jun 18, 2026