Identity
- Trade Name
- TIVOLI bleu T44 EUDAMED
- Device Name
- ATHENES beige T35 EUDAMED
- Model / Reference
- 8337-44 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541060662 EUDAMED
- Basic UDI-DI
- 332254057L3 EUDAMED
- Direct Marketing DI
- 03322541060662 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
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
TIVOLI bleu T44 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 (1)
- EUDAMED 549948a2-b405-4845-b558-b846cc4f5ea0 61 fields · synced Jun 19, 2026