Identity
- Trade Name
- BISENTINA beige T39 EUDAMED
- Device Name
- VENISE noir T35 EUDAMEDATHENES beige T35 EUDAMED
- Model / Reference
- 8279-39 EUDAMED8460-39 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541046765 EUDAMED03322541082312 EUDAMED
- Basic UDI-DI
- 332254059L7 EUDAMED332254057L3 EUDAMED
- Direct Marketing DI
- 03322541046765 EUDAMED03322541082312 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
Yes
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 T39 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 | 332254059L7 | Class I | Active |
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Manufacturer
- Manufacturer
- Gibaud
- EUDAMED SRN
- FR-MF-000014279
Sources (2)
- EUDAMED ec2ec9dc-5ec4-4df4-8c85-1128febca5dc 61 fields · synced Aug 4, 2026
- EUDAMED 8e20e9f0-4cee-49ce-a562-761cba0aefaf 61 fields · synced May 18, 2026