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Neoprene Thigh Support– Extra Large
EUDAMEDClass I (EU MDR)
Ref EX-1004-XL(1)Model FORTUNA – NEOPRENE THIGH SUPPORT
Identity
- Trade Name
- Neoprene Thigh Support– Extra Large EUDAMED
- Device Name
- FORTUNA – NEOPRENE THIGH SUPPORT EUDAMED
- Model / Reference
- FORTUNA – NEOPRENE THIGH SUPPORT EUDAMEDEX-1004-XL(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422387 EUDAMED
- Basic UDI-DI
- 506098242EX-1004S-XXLQ7 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE 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 Thigh Support– Extra 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 | 506098242EX-1004S-XXLQ7 | 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 341dbb1a-3007-463a-b417-2e277d39f25a 61 fields · synced Jul 28, 2026