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Neoprene Dyna Elbow (L)
EUDAMEDClass I (EU MDR)
Ref PNS011Model PREMIA – NEOPRENE DYNA ELBOW SUPPORT
Identity
- Trade Name
- Neoprene Dyna Elbow (L) EUDAMED
- Device Name
- PREMIA – NEOPRENE DYNA ELBOW SUPPORT EUDAMED
- Model / Reference
- PREMIA – NEOPRENE DYNA ELBOW SUPPORT EUDAMEDPNS011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982420833 EUDAMED
- Basic UDI-DI
- 506098242PNSOO9-0124F 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 Dyna 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 | 506098242PNSOO9-0124F | 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 72affbb4-6aa3-4362-880d-d8b58325d2e4 61 fields · synced Jul 14, 2026