Identity
- Trade Name
- Maxillo-Facial Surgery EUDAMED
- Device Name
- MAX (Maxillo-Facial Surgery) EUDAMED
- Model / Reference
- MAX 02 EUDAMEDSYN-MAX02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834176 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP017ZG EUDAMED
- EMDN Code
- P0199 PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL - OTHERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Provides sterile tools for facial reconstructive or corrective surgeries. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Maxillo-Facial Surgery by SYNDEO Medical — 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 | 5065021834SYNPP017ZG | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED f0a80cc1-c0aa-4f35-9859-839c80cd309a 61 fields · synced Jun 18, 2026