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Apolipoprotein B Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref APOB6011Y, APOB6012Y, APOB6013Y, APOB6014Y, APOB6015Y, APOB6011N, APOB6012N, APOB6013N, APOB6014N, APOB6015N
Identity
- Trade Name
- Apolipoprotein B Reagent Kit EUDAMED
- Device Name
- Apolipoprotein B Reagent Kit EUDAMED
- Model / Reference
- APOB6011Y, APOB6012Y, APOB6013Y, APOB6014Y, APOB6015Y, APOB6011N, APOB6012N, APOB6013N, APOB6014N, APOB6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-APOB601VT EUDAMED
- Basic UDI-DI
- B-APOB601VT EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Lipoprotein (a) — Diagam S.A. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Apolipoprotein B Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · IVD General
- 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-APOB601VT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 79b50ae8-1aa1-471f-b6a8-c57c1c6f2633 61 fields · synced Jun 18, 2026
- EUDAMED 79b50ae8-1aa1-471f-b6a8-c57c1c6f2633-1 61 fields · synced Jun 9, 2026