Identity
- Trade Name
- DELPHES noir T36 EUDAMED
- Device Name
- ATHENES beige T35 EUDAMED
- Model / Reference
- 8214-36 EUDAMED8435-36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541026354 EUDAMED03322541079190 EUDAMED
- Basic UDI-DI
- 332254057L3 EUDAMED
- Direct Marketing DI
- 03322541026354 EUDAMED03322541079190 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
DELPHES noir 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 cfebc77c-0375-4f89-b602-8c392c082067 61 fields · synced Jul 30, 2026
- EUDAMED 187f4503-2a10-4d97-9a69-6541d1c399a1 61 fields · synced May 17, 2026