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Elastic Active Ankle Support (s)
EUDAMEDClass I (EU MDR)
Ref PE009Model PREMIA – ELASTIC ACTIVE ANKLE SUPPORT
Identity
- Trade Name
- ELASTIC ACTIVE ANKLE SUPPORT (S) EUDAMED
- Device Name
- PREMIA – ELASTIC ACTIVE ANKLE SUPPORT EUDAMED
- Model / Reference
- PREMIA – ELASTIC ACTIVE ANKLE SUPPORT EUDAMEDPE009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982420581 EUDAMED
- Basic UDI-DI
- 506098242PEA009-012NY 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
Elastic Active Ankle Support (s) 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 | 506098242PEA009-012NY | 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 475dd4f2-35d3-4cdd-a330-f228b6a70ee4 61 fields · synced Jun 18, 2026