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Elastic Active Hand Support (l)
EUDAMEDClass I (EU MDR)
Ref PE019Model PREMIA – ELASTIC ACTIVE HAND SUPPORT
Identity
- Trade Name
- ELASTIC ACTIVE HAND SUPPORT (L) EUDAMED
- Device Name
- PREMIA – ELASTIC ACTIVE HAND SUPPORT EUDAMED
- Model / Reference
- PREMIA – ELASTIC ACTIVE HAND SUPPORT EUDAMEDPE019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982420680 EUDAMED
- Basic UDI-DI
- 506098242PEA017-020NN EUDAMED
- EMDN Code
- Y060606 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
Elastic Active Hand Support (l) 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 | 506098242PEA017-020NN | 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 ea62773e-42ec-48bb-b969-fab73b119c83 61 fields · synced Jun 20, 2026