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Lipoprotein (a) Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060706CModel R1: 90 mL × 2, R2: 15 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 1
Identity
- Device Name
- Lipoprotein (a) Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 90 mL × 2, R2: 15 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH060706C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463395 EUDAMED
- Basic UDI-DI
- B-06975225463395 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Lipoprotein (a) Assay Kit (Latex Immunoturbidimetric Method) by Da Te Bioengineering Technology 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
- APO B — Medicon Hellas SA · IVD General
- Lipoprotein (a) (Lp(a)) Kit(Immunoturbidimetric Method) — Zybio Inc. · IVD General
- Nephstar Apo B Kit — Goldsite Diagnostics Inc. · IVD General
- Lipoprotein (a) Kit (Latex Immunoturbidimetric Method) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
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-06975225463395 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ad8974c2-bf03-44e5-8075-b10bf6065eeb 61 fields · synced Jun 19, 2026