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Apolipoprotein B Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060601Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH060609Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH060610Model R1: 60 mL×4; R2: 15 mL×4
Identity
- Device Name
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH060601 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH060609 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH060610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462299 EUDAMED06975225462275 EUDAMED06975225462282 EUDAMED
- Basic UDI-DI
- B-06975225462299 EUDAMEDB-06975225462275 EUDAMEDB-06975225462282 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B 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
Apolipoprotein B Assay Kit (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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- 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-06975225462299 | 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 (3)
- EUDAMED ff2e9e5b-f4d3-4d38-84a1-be00fc9d24e2 61 fields · synced Jul 21, 2026
- EUDAMED 66382303-6474-4dd7-a3fb-27d2e81b84b1 61 fields · synced May 17, 2026
- EUDAMED 7dc406b9-68dd-4a8d-9c97-6935cfd593cc 61 fields · synced May 18, 2026