← Back to catalogue
Neoprene Tech Elbow (S)
EUDAMEDClass I (EU MDR)
Ref PNT010Model PREMIA® NEOPRENE TECH ELBOW
Identity
- Trade Name
- Neoprene Tech Elbow (S) EUDAMED
- Device Name
- PREMIA® NEOPRENE TECH ELBOW EUDAMED
- Model / Reference
- PREMIA® NEOPRENE TECH ELBOW EUDAMEDPNT010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421373 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 (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 | 506098242PNT009-0128T | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fima Global Brands Ltd
- EUDAMED SRN
- UK-MF-000036604
- Authorised Representative
- GLORY-Cosmetic Hungary Kft. HU-AR-000035374
Sources (1)
- EUDAMED b188d634-462e-48f4-8e23-3b6dd76ce804 61 fields · synced Jul 10, 2026