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Elasticated Hand Support Large
EUDAMEDClass I (EU MDR)
Ref FT-991-L(1)Model FORTUNA –ELASTICATED HAND SUPPORT
Identity
- Trade Name
- ELASTICATED HAND SUPPORT LARGE EUDAMED
- Device Name
- FORTUNA –ELASTICATED HAND SUPPORT EUDAMED
- Model / Reference
- FORTUNA –ELASTICATED HAND SUPPORT EUDAMEDFT-991-L(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422882 EUDAMED
- Basic UDI-DI
- 506098242FT-989-992PL EUDAMED
- EMDN Code
- Y060606 HAND 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
Elasticated Hand Support Large 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-989-992PL | 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 c87a26f2-4cc0-48a8-bbc1-4be59152e61b 61 fields · synced Jul 9, 2026