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Neoprene Wrist Splint- Left - Small
EUDAMEDClass I (EU MDR)
Ref FT-005(1)Model FORTUNA - NEOPRENE WRIST SPLINT
Identity
- Trade Name
- NEOPRENE WRIST SPLINT- LEFT - SMALL EUDAMED
- Device Name
- FORTUNA - NEOPRENE WRIST SPLINT EUDAMED
- Model / Reference
- FORTUNA - NEOPRENE WRIST SPLINT EUDAMEDFT-005(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422301 EUDAMED
- Basic UDI-DI
- 506098242FT-005-098D6 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
Neoprene Wrist Splint- Left - Small 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 | 506098242FT-005-098D6 | 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 f07d40ff-6171-4198-9403-90bc29c36a59 61 fields · synced Jul 16, 2026