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Neoprene Tech Elbow (L)
EUDAMEDClass I (EU MDR)
Ref PNT011Model PREMIA® NEOPRENE TECH ELBOW
Identity
- Trade Name
- Neoprene Tech Elbow (L) EUDAMED
- Device Name
- PREMIA® NEOPRENE TECH ELBOW EUDAMED
- Model / Reference
- PREMIA® NEOPRENE TECH ELBOW EUDAMEDPNT011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421403 EUDAMED
- Basic UDI-DI
- 506098242PNT009-0128T 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
Neoprene Tech Elbow (L) 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 | 506098242PNT009-0128T | 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 d49ded59-99f5-4603-abf3-748dfe1753e7 61 fields · synced Jun 18, 2026