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Direct Bilirubin Kit（vanadate Oxidation Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3017285Model R1: 4x50mL, R2: 1x50mLRef 3021731Ref 3023190Ref 3017283Ref 3000505Model R1: 4x80mL, R2: 4x20mL
Identity
- Trade Name
- DIRECT BILIRUBIN KIT（VANADATE OXIDATION METHOD） EUDAMED
- Device Name
- DIRECT BILIRUBIN KIT（VANADATE OXIDATION METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL EUDAMED3017285 EUDAMED3021731 EUDAMED3023190 EUDAMED3017283 EUDAMEDR1: 4x80mL, R2: 4x20mL EUDAMED3000505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259142 EUDAMED06925794593795 EUDAMED06942202212963 EUDAMED06942202259135 EUDAMED06942202259128 EUDAMED
- Basic UDI-DI
- B-06942202259142 EUDAMEDB-06925794593795 EUDAMEDB-06942202212963 EUDAMEDB-06942202259135 EUDAMEDB-06942202259128 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
Direct 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-06942202259142 | 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 (5)
- EUDAMED 73a5ff5e-80d1-4102-8355-dff827bed8c0 61 fields · synced Sep 18, 2026
- EUDAMED b5df6262-6797-4a2a-884e-f2a216ce0018 61 fields · synced May 17, 2026
- EUDAMED 9f8317c1-0bdd-4a84-ad9c-95e6bb7b6ba1 61 fields · synced May 18, 2026
- EUDAMED 1271b495-80db-438a-8028-48e780341ec5 61 fields · synced May 18, 2026
- EUDAMED 57ade47a-5e97-44ef-81dc-8f1c9d80e532 61 fields · synced May 18, 2026