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Neoprene Tech Knee (L)
EUDAMEDClass I (EU MDR)
Ref PNT003Model PREMIA® NEOPRENE TECH KNEE
Identity
- Trade Name
- Neoprene Tech Knee (L) EUDAMED
- Device Name
- PREMIA® NEOPRENE TECH KNEE EUDAMED
- Model / Reference
- PREMIA® NEOPRENE TECH KNEE EUDAMEDPNT003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421359 EUDAMED
- Basic UDI-DI
- 506098242PNT001-00464 EUDAMED
- EMDN Code
- Y06120601 PASSIVE 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
Category: Ankle/foot orthosis
Neoprene Tech Knee (L) by Fima Global Brands Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 6e6abf9f-9424-4cb8-a715-ff5f56278461 61 fields · synced Jul 30, 2026