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Foam Arm Sling (UNI)
EUDAMEDClass I (EU MDR)
Ref POR004Model PREMIA – FOAM ARM SLING (UNI)
Identity
- Trade Name
- Foam Arm Sling (UNI) EUDAMED
- Device Name
- PREMIA – FOAM ARM SLING (UNI) EUDAMED
- Model / Reference
- PREMIA – FOAM ARM SLING (UNI) EUDAMEDPOR004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421076 EUDAMED
- Basic UDI-DI
- 506098242P0R004XP EUDAMED
- EMDN Code
- Y060621 SHOULDER 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
Foam Arm Sling (UNI) 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 | 506098242P0R004XP | 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 f2857055-fd72-4f22-b2ca-0886eb54ca69 61 fields · synced Jun 18, 2026