← Back to catalogue
Fortuna – Neoprene Wrist Support
EUDAMEDClass I (EU MDR)
Ref EX903-U(1)Model FORTUNA – NEOPRENE WRIST SUPPORT
Identity
- Trade Name
- FORTUNA – NEOPRENE WRIST SUPPORT EUDAMED
- Device Name
- FORTUNA – NEOPRENE WRIST SUPPORT EUDAMED
- Model / Reference
- FORTUNA – NEOPRENE WRIST SUPPORT EUDAMEDEX903-U(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422240 EUDAMED
- Basic UDI-DI
- 506098242EX903-U(1)SB 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
Fortuna – Neoprene Wrist Support 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 | 506098242EX903-U(1)SB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fima Global Brands Ltd
- EUDAMED SRN
- UK-MF-000036604
- Authorised Representative
- GLORY-Cosmetic Hungary Kft. HU-AR-000035374
Sources (1)
- EUDAMED bfb13b56-2513-48c4-b4b3-288dbca0f600 61 fields · synced Aug 1, 2026