Identity
- Trade Name
- LEVITHA noir T35 EUDAMED
- Device Name
- ATHENES beige T35 EUDAMED
- Model / Reference
- 8303-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541053022 EUDAMED
- Basic UDI-DI
- 332254057L3 EUDAMED
- Direct Marketing DI
- 03322541053022 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
LEVITHA noir T35 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gibaud
- EUDAMED SRN
- FR-MF-000014279
Sources (1)
- EUDAMED 1c4ea73e-52fa-4b0a-bf9b-172021a92b6a 61 fields · synced Jun 18, 2026