Identity
- Trade Name
- MALLEOGIB articulée T1 EUDAMED
- Device Name
- Orthèse stab cheville GIBORTHO EUDAMED
- Model / Reference
- 6585-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541011176 EUDAMED
- Basic UDI-DI
- 332254048L2 EUDAMED
- Direct Marketing DI
- 03322541011176 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES 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
MALLEOGIB articulée T1 by Gibaud — 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 | 332254048L2 | Class I | Active |
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Manufacturer
- Manufacturer
- Gibaud
- EUDAMED SRN
- FR-MF-000014279
Sources (1)
- EUDAMED d37ce0ab-a208-4e62-8289-36d69ad2a2d4 61 fields · synced Jun 18, 2026