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Neoprene Ankle Support With Heel Lock Small
EUDAMEDClass I (EU MDR)
Ref FT-SN-022-S(1)Model FORTUNA –NEOPRENE ANKLE SUPPORT WITH HEEL LOCK
Identity
- Trade Name
- NEOPRENE ANKLE SUPPORT WITH HEEL LOCK SMALL EUDAMED
- Device Name
- FORTUNA –NEOPRENE ANKLE SUPPORT WITH HEEL LOCK EUDAMED
- Model / Reference
- FORTUNA –NEOPRENE ANKLE SUPPORT WITH HEEL LOCK EUDAMEDFT-SN-022-S(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422196 EUDAMED
- Basic UDI-DI
- 506098242FT-SN-022-025VW EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Neoprene Ankle Support With Heel Lock Small by Fima Global Brands Ltd — 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 | 506098242FT-SN-022-025VW | Class I | Active |
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Manufacturer
- Manufacturer
- Fima Global Brands Ltd
- EUDAMED SRN
- UK-MF-000036604
- Authorised Representative
- GLORY-Cosmetic Hungary Kft. HU-AR-000035374
Sources (1)
- EUDAMED 24a5383d-1777-477e-ac03-8194fd625b26 61 fields · synced Jun 18, 2026