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Orthopaedic Foam Arm Sling
EUDAMEDClass I (EU MDR)
Ref FT-SM-001(1)Model FORTUNA - ORTHOPAEDIC FOAM ARM SLING
Identity
- Trade Name
- ORTHOPAEDIC FOAM ARM SLING EUDAMED
- Device Name
- FORTUNA - ORTHOPAEDIC FOAM ARM SLING EUDAMED
- Model / Reference
- FORTUNA - ORTHOPAEDIC FOAM ARM SLING EUDAMEDFT-SM-001(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422059 EUDAMED
- Basic UDI-DI
- 506098242FT-SM-001(1)2U EUDAMED
- EMDN Code
- M030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE 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
Orthopaedic Foam Arm Sling 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-SM-001(1)2U | 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 986896b8-bd69-4dc7-bad0-703a806bdb16 61 fields · synced Jul 20, 2026