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Premium Elasticated Wrist Support Large
EUDAMEDClass I (EU MDR)
Ref INT-023(1)Model FORTUNA -PREMIUM ELASTICATED WRIST SUPPORT
Identity
- Trade Name
- PREMIUM ELASTICATED WRIST SUPPORT LARGE EUDAMED
- Device Name
- FORTUNA -PREMIUM ELASTICATED WRIST SUPPORT EUDAMED
- Model / Reference
- FORTUNA -PREMIUM ELASTICATED WRIST SUPPORT EUDAMEDINT-023(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422097 EUDAMED
- Basic UDI-DI
- 506098242INT-021-023BU EUDAMED
- EMDN Code
- Y060612 WRIST-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
Premium Elasticated Wrist 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 | 506098242INT-021-023BU | 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 35e8387c-eb4c-4e75-8de5-d7ef7aec43c9 61 fields · synced Jul 15, 2026