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Elasticated Ankle Support Extra Large
EUDAMEDClass I (EU MDR)
Ref FT-1102-XL(1)Model FORTUNA -ELASTICATED ANKLE SUPPORTRef FT-1102-XL(1)BEIGE
Identity
- Trade Name
- ELASTICATED ANKLE SUPPORT EXTRA LARGE EUDAMED
- Device Name
- FORTUNA -ELASTICATED ANKLE SUPPORT EUDAMED
- Model / Reference
- FORTUNA -ELASTICATED ANKLE SUPPORT EUDAMEDFT-1102-XL(1) EUDAMEDFT-1102-XL(1)BEIGE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982423063 EUDAMED05060982423117 EUDAMED
- Basic UDI-DI
- 506098242FT-1102-S-XXL2M 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
Category: Ankle/foot orthosis
Elasticated Ankle Support Extra Large by Fima Global Brands Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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-1102-S-XXL2M | 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 d30c9eca-5d2e-430d-b432-437a09db68de 61 fields · synced Jul 12, 2026
- EUDAMED 08fc96e1-e8e2-4366-ad63-449252aee49d 61 fields · synced May 19, 2026