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Neoprene Ankle Support With Heel Lock Xx Large
EUDAMEDClass I (EU MDR)
Ref FT-SN-025-XXL(1)Model FORTUNA –NEOPRENE ANKLE SUPPORT WITH HEEL LOCKRef FT-SN-025-XL(1)
Identity
- Trade Name
- NEOPRENE ANKLE SUPPORT WITH HEEL LOCK XX LARGE EUDAMED
- Device Name
- FORTUNA –NEOPRENE ANKLE SUPPORT WITH HEEL LOCK EUDAMED
- Model / Reference
- FORTUNA –NEOPRENE ANKLE SUPPORT WITH HEEL LOCK EUDAMEDFT-SN-025-XXL(1) EUDAMEDFT-SN-025-XL(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422233 EUDAMED05060982422226 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 Xx Large 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 (2)
- EUDAMED 247f2147-37c6-4b8f-8554-37a3f1e05c5e 61 fields · synced Oct 5, 2026
- EUDAMED 25f7808a-5e92-4f48-8e14-aabaf6a087ec 61 fields · synced May 18, 2026