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Magnetic Neoprenr Wrist Support- Universal(uni)
EUDAMEDClass I (EU MDR)
Ref INT-044(1)Model FORTUNA - NEOPRENE MAGNETIC WRIST SUPPORT (UNI)
Identity
- Trade Name
- MAGNETIC NEOPRENR WRIST SUPPORT- UNIVERSAL(UNI) EUDAMED
- Device Name
- FORTUNA - NEOPRENE MAGNETIC WRIST SUPPORT (UNI) EUDAMED
- Model / Reference
- FORTUNA - NEOPRENE MAGNETIC WRIST SUPPORT (UNI) EUDAMEDINT-044(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422578 EUDAMED
- Basic UDI-DI
- 506098242INT-044(1)WS EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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 Neoprenr Wrist 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-044(1)WS | 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 aa14ff07-5cb8-4c7d-98e7-f0bd0db886ae 61 fields · synced Jun 18, 2026