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Elastic Active Knee Support With Stays (xl)
EUDAMEDClass I (EU MDR)
Ref PEA008Model PREMIA – ELASTIC ACTIVE KNEE SUPPORT WITH STAYS
Identity
- Trade Name
- ELASTIC ACTIVE KNEE SUPPORT WITH STAYS (XL) EUDAMED
- Device Name
- PREMIA – ELASTIC ACTIVE KNEE SUPPORT WITH STAYS EUDAMED
- Model / Reference
- PREMIA – ELASTIC ACTIVE KNEE SUPPORT WITH STAYS EUDAMEDPEA008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982420574 EUDAMED
- Basic UDI-DI
- 506098242PEA005-008MV EUDAMED
- EMDN Code
- Y061209 KNEE 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 Knee Support With Stays (xl) 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 | 506098242PEA005-008MV | 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 f044c4bd-81b3-474b-8fea-61ff3bdcf008 61 fields · synced Jul 13, 2026