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Neoprene Tech Knee (S)
EUDAMEDClass I (EU MDR)
Ref PNT001Model PREMIA® NEOPRENE TECH KNEE
Identity
- Trade Name
- Neoprene Tech Knee (S) EUDAMED
- Device Name
- PREMIA® NEOPRENE TECH KNEE EUDAMED
- Model / Reference
- PREMIA® NEOPRENE TECH KNEE EUDAMEDPNT001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421335 EUDAMED
- Basic UDI-DI
- 506098242PNT001-00464 EUDAMED
- EMDN Code
- Y06121201 PASSIVE KNEE-ANKLE-FOOT 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 Knee (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 | 506098242PNT001-00464 | 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 c62542cb-d0e3-4f4e-8467-1ccc06b64cf2 61 fields · synced Jun 19, 2026