Identity
- Trade Name
- BACK WARMERS EUDAMED
- Device Name
- AURACARE- BACK WARMERS EUDAMED
- Model / Reference
- AURACARE- BACK WARMERS EUDAMEDACW-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060982423308 EUDAMED
- Basic UDI-DI
- 506098242ACW-0042B EUDAMED
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS 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
Back Warmers 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 | 506098242ACW-0042B | 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 5dd9fd6b-4dc1-43a1-a826-12fb847fccfb 61 fields · synced Jul 30, 2026