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Neoprene Easy Wrist (UNI)
EUDAMEDClass I (EU MDR)
Ref PNE005Model PREMIA® NEOPRENE EASY WRIST (UNI)
Identity
- Trade Name
- Neoprene Easy Wrist (UNI) EUDAMED
- Device Name
- PREMIA® NEOPRENE EASY WRIST (UNI) EUDAMED
- Model / Reference
- PREMIA® NEOPRENE EASY WRIST (UNI) EUDAMEDPNE005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421458 EUDAMED
- Basic UDI-DI
- 506098242PNE0056Y EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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
Neoprene Easy Wrist (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 | 506098242PNE0056Y | 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 6a2d0532-687f-4762-8a8c-6c70fc867b25 61 fields · synced Jul 10, 2026