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Contour Cervical Collar (L)
EUDAMEDClass I (EU MDR)
Ref POR010Model PREMIA – CERVICAL COLLAR
Identity
- Trade Name
- Contour Cervical Collar (L) EUDAMED
- Device Name
- PREMIA – CERVICAL COLLAR EUDAMED
- Model / Reference
- PREMIA – CERVICAL COLLAR EUDAMEDPOR010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982421069 EUDAMED
- Basic UDI-DI
- 506098242P0R008-010J8 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
Contour Cervical Collar (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 | 506098242P0R008-010J8 | 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 eccc93b1-9166-4141-aa76-932c6436bac3 61 fields · synced Jun 17, 2026