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Apolipoprotein B Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ402YModel 240mL（R1:4×45mL+R2:4×15mL）
Identity
- Trade Name
- Apolipoprotein B Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Apolipoprotein B Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 240mL（R1:4×45mL+R2:4×15mL） EUDAMEDMJ402Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750201 EUDAMED
- Basic UDI-DI
- B-06936595750201 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Apolipoprotein B (Apo B) IVD, reagent
Apolipoprotein B Kit (Immunoturbidimetric Method) by Medicalsystem Biotechnology 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
- 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
- 5’-Nucleotidase 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-06936595750201 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8f63ad66-8973-4a49-a883-91fcfc4a6223 61 fields · synced Jul 9, 2026