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Neoprene Ankle Support Large
EUDAMEDClass I (EU MDR)
Ref EX1102-L(1)Model FORTUNA -NEOPRENE ANKLE SUPPORT
Identity
- Trade Name
- NEOPRENE ANKLE SUPPORT LARGE EUDAMED
- Device Name
- FORTUNA -NEOPRENE ANKLE SUPPORT EUDAMED
- Model / Reference
- FORTUNA -NEOPRENE ANKLE SUPPORT EUDAMEDEX1102-L(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422547 EUDAMED
- Basic UDI-DI
- 506098242EX1102-S-XXLS2 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 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 | 506098242EX1102-S-XXLS2 | 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 61f1778b-6cf2-4aac-bbfc-aa2167201937 61 fields · synced Jul 13, 2026