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Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3000478Model R1: 2x80mL, R2: 1x4mL, Calibration sample: 2mL
Identity
- Trade Name
- TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD) EUDAMED
- Device Name
- TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD) EUDAMED
- Model / Reference
- R1: 2x80mL, R2: 1x4mL, Calibration sample: 2mL EUDAMED3000478 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259173 EUDAMED
- Basic UDI-DI
- B-06942202259173 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06942202259173 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 2371119a-2e10-48ae-877d-ebe28a4638cf 61 fields · synced Jun 18, 2026