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Apolipoprotein B Reagent Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3021178Model R1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL
Identity
- Trade Name
- APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL EUDAMED3021178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261176 EUDAMED
- Basic UDI-DI
- B-06942202261176 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Category: Apolipoprotein B (Apo B) IVD, reagent
Apolipoprotein B Reagent Kit（immunoturbidimetric Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
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- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
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-06942202261176 | 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 fd7c2c3a-f2c5-47b0-aefe-1bb7d518080a 61 fields · synced Jun 18, 2026