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Pro Series– Elbow Support (S)
EUDAMEDClass I (EU MDR)
Ref PEP004-SModel PREMIA –PRO SERIES – ELBOW SUPPORT
Identity
- Trade Name
- Pro Series– Elbow Support (S) EUDAMED
- Device Name
- PREMIA –PRO SERIES – ELBOW SUPPORT EUDAMED
- Model / Reference
- PREMIA –PRO SERIES – ELBOW SUPPORT EUDAMEDPEP004-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421120 EUDAMED
- Basic UDI-DI
- 506098242PEP004S-XLAZ 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
Pro Series– Elbow 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 | 506098242PEP004S-XLAZ | 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 93fc6d03-abe8-438a-8507-f623efbe691f 61 fields · synced Jun 19, 2026