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Premium Elasticated Elbow Support Small
EUDAMEDClass I (EU MDR)
Ref INT-018(1) Model FORTUNA -PREMIUM ELASTICATED ELBOW SUPPORT
Identity
- Trade Name
- PREMIUM ELASTICATED ELBOW SUPPORT SMALL EUDAMED
- Device Name
- FORTUNA -PREMIUM ELASTICATED ELBOW SUPPORT EUDAMED
- Model / Reference
- FORTUNA -PREMIUM ELASTICATED ELBOW SUPPORT EUDAMEDINT-018(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422134 EUDAMED
- Basic UDI-DI
- 506098242INT-018-020DN EUDAMED
- EMDN Code
- Y060615 ELBOW 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 Elbow Support 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 | 506098242INT-018-020DN | 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 bdbe32ed-53c3-4d45-96b7-e290616b7dde 61 fields · synced Jun 19, 2026