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Magnetic Neoprene KNEE Support - Universal (UNI)
EUDAMEDClass I (EU MDR)
Ref INT-046(1)Model FORTUNA - NEOPRENE MAGNETIC KNEE SUPPORT (UNI)
Identity
- Trade Name
- Magnetic Neoprene KNEE Support - Universal (UNI) EUDAMED
- Device Name
- FORTUNA - NEOPRENE MAGNETIC KNEE SUPPORT (UNI) EUDAMED
- Model / Reference
- FORTUNA - NEOPRENE MAGNETIC KNEE SUPPORT (UNI) EUDAMEDINT-046(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422608 EUDAMED
- Basic UDI-DI
- 506098242INT-046(1)X8 EUDAMED
- EMDN Code
- Y061209 KNEE 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
Magnetic Neoprene KNEE Support - Universal (UNI) 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 | 506098242INT-046(1)X8 | 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 9a755e51-44f2-423b-90d4-c389fccdd1fd 61 fields · synced Jul 16, 2026