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Apolipoprotein B (APO-B) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 96H160TSCRef 96H40TRef 96H160T
Identity
- Trade Name
- Apolipoprotein B (APO-B) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Apolipoprotein B (APO-B) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 96H160TSC EUDAMED96H40T EUDAMED96H160T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-96H160TSCDC EUDAMEDD-96H40TY9 EUDAMEDD-96H160TC6 EUDAMED
- Basic UDI-DI
- B-96H160TSCDC EUDAMEDB-96H40TY9 EUDAMEDB-96H160TC6 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
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
Category: Apolipoprotein B (Apo B) IVD, reagent
Apolipoprotein B (APO-B) Assay Kit (Immunoturbidimetric Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
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- 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-96H160TSCDC | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 19faf531-8efd-4bd9-9e88-43f2876319d1 61 fields · synced Jul 10, 2026
- EUDAMED a958afe0-9e11-468b-995c-19b6715d86c2 61 fields · synced May 18, 2026
- EUDAMED a9e291d0-446c-402a-8ec5-c20c5b227c58 61 fields · synced May 19, 2026