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Elastic Ankle Wrap (UNI)
EUDAMEDClass I (EU MDR)
Ref PEW002Model PREMIA – ELASTIC ANKLE WRAP (UNI)
Identity
- Trade Name
- Elastic Ankle Wrap (UNI) EUDAMED
- Device Name
- PREMIA – ELASTIC ANKLE WRAP (UNI) EUDAMED
- Model / Reference
- PREMIA – ELASTIC ANKLE WRAP (UNI) EUDAMEDPEW002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421113 EUDAMED
- Basic UDI-DI
- 506098242PEW0027M EUDAMED
- EMDN Code
- Y06121203 ACTIVE KNEE-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
Elastic Ankle Wrap (UNI) 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 | 506098242PEW0027M | 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 e4fab4a8-f7cf-4db2-9d8a-e64f795130fd 61 fields · synced Jul 14, 2026