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Pouch Arm Sling
EUDAMEDClass I (EU MDR)
Ref YS1901-A(1)Model Fortuna Pouch Arm Sling
Identity
- Trade Name
- Pouch Arm Sling EUDAMED
- Device Name
- Fortuna Pouch Arm Sling EUDAMED
- Model / Reference
- Fortuna Pouch Arm Sling EUDAMEDYS1901-A(1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982422011 EUDAMED
- Basic UDI-DI
- 506098242INT-172AP EUDAMED
- EMDN Code
- Y060630 SHOULDER-ELBOW-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
Pouch 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 | 506098242INT-172AP | 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 79c47142-7eca-4542-bed2-f53f5afe2691 61 fields · synced Jun 18, 2026