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Elastic Elbow Wrap (UNI)
EUDAMEDClass I (EU MDR)
Ref PEW003Model PREMIA – ELASTIC ELBOW WRAP (UNI)
Identity
- Trade Name
- Elastic Elbow Wrap (UNI) EUDAMED
- Device Name
- PREMIA – ELASTIC ELBOW WRAP (UNI) EUDAMED
- Model / Reference
- PREMIA – ELASTIC ELBOW WRAP (UNI) EUDAMEDPEW003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421083 EUDAMED
- Basic UDI-DI
- 506098242PEW0037P EUDAMED
- EMDN Code
- Y060615 ELBOW 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 Elbow 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 | 506098242PEW0037P | 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 5a5c2249-6080-40b0-b021-6ae505b3fc8e 61 fields · synced Sep 17, 2026