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Total Bilirubin
EUDAMEDClass C (EU MDR)
Ref 1419-0142Ref 1415-0140Ref 1418-0149
Identity
- Trade Name
- TOTAL BILIRUBIN EUDAMED
- Device Name
- TOTAL BILIRUBIN EUDAMED
- Model / Reference
- 1419-0142 EUDAMED1415-0140 EUDAMED1418-0149 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309161362 EUDAMED05204309167326 EUDAMED05204309089130 EUDAMED
- Basic UDI-DI
- 5204309000041NQ EUDAMED
- Direct Marketing DI
- 05204309161362 EUDAMED05204309167326 EUDAMED05204309089130 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Total Bilirubin by Medicon Hellas SA — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5204309000041NQ | Class C | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (3)
- EUDAMED fd394852-e163-4513-9b13-7386b810c3d5 61 fields · synced Sep 18, 2026
- EUDAMED 655cdc57-a77f-4c25-8f90-d115fabfb90d 61 fields · synced May 18, 2026
- EUDAMED 708d117b-57a2-4620-bc44-39752587814f 61 fields · synced May 18, 2026