Identity
- Trade Name
- BISENTINA BEIGE T36 EUDAMED
- Device Name
- ATHENES beige T35 EUDAMEDVENISE noir T35 EUDAMED
- Model / Reference
- 8460-36 EUDAMED8279-36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541082282 EUDAMED03322541046734 EUDAMED
- Basic UDI-DI
- 332254057L3 EUDAMED332254059L7 EUDAMED
- Direct Marketing DI
- 03322541082282 EUDAMED03322541046734 EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES 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
EUDAMEDEUDAMED
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
Bisentina Beige T36 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 | 332254057L3 | Class I | Active |
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Manufacturer
- Manufacturer
- Gibaud
- EUDAMED SRN
- FR-MF-000014279
Sources (2)
- EUDAMED 941c365a-c221-4605-bf8a-9f5ec1faace2 61 fields · synced Sep 17, 2026
- EUDAMED ca130e27-155c-41e3-856a-b3066ecff3c1 61 fields · synced May 18, 2026