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Direct Bilirubin
EUDAMEDClass C (EU MDR)
Ref 1419-0152Ref 1415-0150Ref 1418-0159
Identity
- Trade Name
- DIRECT BILIRUBIN EUDAMED
- Device Name
- DIRECT BILIRUBIN EUDAMED
- Model / Reference
- 1419-0152 EUDAMED1415-0150 EUDAMED1418-0159 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309161355 EUDAMED05204309167333 EUDAMED05204309089185 EUDAMED
- Basic UDI-DI
- 5204309000021NJ 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
Direct 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 | 5204309000021NJ | Class C | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (3)
- EUDAMED 98fb800f-fd8f-4c3e-8036-6ac96b45e535 61 fields · synced Jul 20, 2026
- EUDAMED 9ab94ebf-ead0-4352-a1ff-561e8e47fd9a 61 fields · synced May 18, 2026
- EUDAMED 57046862-bc7a-4e04-b0f6-5103e1267c5d 61 fields · synced May 18, 2026