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Total Bilirubin Kit（vanadate Oxidation Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3017278Model R1: 4x50mL, R2: 1x50mLRef 3023189Ref 3017282Ref 3000482Model R1: 2x60mL, R2: 2x15mL
Identity
- Trade Name
- TOTAL BILIRUBIN KIT（VANADATE OXIDATION METHOD） EUDAMED
- Device Name
- TOTAL BILIRUBIN KIT（VANADATE OXIDATION METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL EUDAMED3017278 EUDAMED3023189 EUDAMED3017282 EUDAMEDR1: 2x60mL, R2: 2x15mL EUDAMED3000482 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259234 EUDAMED06942202212956 EUDAMED06942202259241 EUDAMED06942202259227 EUDAMED
- Basic UDI-DI
- B-06942202259234 EUDAMEDB-06942202212956 EUDAMEDB-06942202259241 EUDAMEDB-06942202259227 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 Kit（vanadate Oxidation Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202259234 | 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 (4)
- EUDAMED c615fcc5-3a20-41db-875b-1619a47b3bee 61 fields · synced Jul 31, 2026
- EUDAMED f724e003-08f1-4b34-8851-0ace6a41bf29 61 fields · synced May 18, 2026
- EUDAMED f1393483-7ae3-4170-8c62-bde55554f566 61 fields · synced May 18, 2026
- EUDAMED 29f17ea4-e0cf-49be-9c75-ba5438081d52 61 fields · synced May 18, 2026