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Direct Bilirubin Reagent Kit (Diazo Salt Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3015093Model R1: 4x50mL, R2: 1x50mLRef 3021148Model R1: 5x50mL, R2: 1x3mL，Calibration sample: 2mLRef 3024549Model R1: 12x20mL, R2: 1x3mL，Calibration sample: 2mLRef 3000501Model R1: 2x80mL, R2: 1x2mL, Calibration sample: 2mLRef 3023558Ref 3021559Ref 3023578Ref 3016561
Identity
- Trade Name
- Direct Bilirubin Reagent Kit (Diazo Salt Method) EUDAMEDDIRECT BILIRUBIN REAGENT KIT(DIAZO SALT METHOD) EUDAMED
- Device Name
- Direct Bilirubin Reagent Kit (Diazo Salt Method) EUDAMEDDIRECT BILIRUBIN REAGENT KIT(DIAZO SALT METHOD) EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL EUDAMED3015093 EUDAMEDR1: 5x50mL, R2: 1x3mL，Calibration sample: 2mL EUDAMED3021148 EUDAMEDR1: 12x20mL, R2: 1x3mL，Calibration sample: 2mL EUDAMED3024549 EUDAMEDR1: 2x80mL, R2: 1x2mL, Calibration sample: 2mL EUDAMED3000501 EUDAMED3023558 EUDAMED3021559 EUDAMED3023578 EUDAMED3016561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259159 EUDAMED06942202259098 EUDAMED06942202226311 EUDAMED06942202259067 EUDAMED06942202216077 EUDAMED06925794593788 EUDAMED06942202216084 EUDAMED06942202259104 EUDAMED
- Basic UDI-DI
- B-06942202259159 EUDAMEDB-06942202259098 EUDAMEDB-06942202226311 EUDAMEDB-06942202259067 EUDAMEDB-06942202216077 EUDAMEDB-06925794593788 EUDAMEDB-06942202216084 EUDAMEDB-06942202259104 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 Reagent Kit (Diazo Salt 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-06942202259159 | 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 (8)
- EUDAMED 04a6663e-afd7-4fd3-9561-5581ba4153a2 61 fields · synced Aug 2, 2026
- EUDAMED f9e1d759-3d6a-4c2c-8a5c-4675c12bb7a2 61 fields · synced May 16, 2026
- EUDAMED 7bde0f78-957c-40de-b60f-2cac7a283318 61 fields · synced May 16, 2026
- EUDAMED 294ce78c-5227-4c68-bb7e-a3805a4657ec 61 fields · synced May 16, 2026
- EUDAMED eaa63589-e219-49fa-b0a6-925abd7beaf2 61 fields · synced May 17, 2026
- EUDAMED 46b3602d-8517-4ffb-a546-432c5dfbe5be 61 fields · synced May 18, 2026
- EUDAMED 7851c712-ef02-4440-8113-db8241712c2c 61 fields · synced May 18, 2026
- EUDAMED cfb13c67-8b13-4e83-b16a-2f69ac9cfc3d 61 fields · synced May 19, 2026