Identity
- Trade Name
- Orthèse poignet pouce T1D EUDAMED
- Device Name
- ORTESI POLSO POLLICE DX JUNIOR EUDAMED
- Model / Reference
- 6609-1D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541022684 EUDAMED
- Basic UDI-DI
- 332254031KH EUDAMED
- Direct Marketing DI
- 03322541022684 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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
Orthèse poignet pouce T1D 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 | 332254031KH | Class I | Active |
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Manufacturer
- Manufacturer
- Gibaud
- EUDAMED SRN
- FR-MF-000014279
Sources (1)
- EUDAMED 7d9e3a6d-9cea-444a-8f39-23495a5317fc 61 fields · synced Jul 8, 2026