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Model 1xl Black 41
EUDAMEDClass I (EU MDR)
Ref FD0107Model MODEL 1 - MODEL W - MODEL H
Identity
- Trade Name
- MODEL 1XL BLACK 41 EUDAMED
- Device Name
- MODEL 1 (BLACK, BLUE, GREY, LIGHT GREY, LILAC, WHITE) - MODEL W (ANTHRACITE, SAND) - MODEL H (BLACK, OPEN GREY, SABOT, SLIPPER) EUDAMED
- Model / Reference
- MODEL 1 - MODEL W - MODEL H EUDAMEDFD0107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057639746627 EUDAMED
- Basic UDI-DI
- 805763974FD0NB EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Model 1xl Black 41 by Well Walking S.r.l. — 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 | 805763974FD0NB | Class I | Active |
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Manufacturer
- Manufacturer
- Well Walking S.r.l.
- EUDAMED SRN
- IT-MF-000037941
Sources (1)
- EUDAMED 9e2631b5-1a33-4aa8-b207-266a2461e115 61 fields · synced Oct 7, 2026