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Model H Black 45
EUDAMEDClass I (EU MDR)
Ref FH0101Model MODEL 1 - MODEL W - MODEL H
Identity
- Trade Name
- MODEL H BLACK 45 EUDAMED
- Device Name
- MODEL 1 (BLACK, BLUE, GREY, LIGHT GREY, LILAC) - MODEL W (ANTHRACITE, SAND) - MODEL H (BLACK, OPEN GREY) EUDAMED
- Model / Reference
- MODEL 1 - MODEL W - MODEL H EUDAMEDFH0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057639745712 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 H Black 45 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 1a262b11-576a-4e8f-a709-653fd0165fa8 61 fields · synced Oct 8, 2026