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Apolipoprotein A1 Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060506Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH060607Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH060505Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH060501Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH060510Model R1: 60 mL×4; R2: 15 mL×4
Identity
- Device Name
- Apolipoprotein A1 Assay Kit (Immunoturbidimetric Method) EUDAMEDApolipoprotein B Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH060506 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH060607 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH060505 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH060501 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH060510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462169 EUDAMED06975225462251 EUDAMED06975225462152 EUDAMED06975225462213 EUDAMED06975225462206 EUDAMED
- Basic UDI-DI
- B-06975225462169 EUDAMEDB-06975225462251 EUDAMEDB-06975225462152 EUDAMEDB-06975225462213 EUDAMEDB-06975225462206 EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMEDW0102010403 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
Apolipoprotein A1 Assay Kit (Immunoturbidimetric Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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-06975225462169 | 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 (5)
- EUDAMED 8178fc65-fe42-483d-aec5-21c2385101c7 61 fields · synced Jul 16, 2026
- EUDAMED 8f945217-daf6-4d12-a43a-bd5ad19fd234 61 fields · synced May 16, 2026
- EUDAMED 0ceeb161-11ca-4ab2-8586-67a4d98138d9 61 fields · synced May 17, 2026
- EUDAMED c1e03efe-701e-4aed-ab2f-45038d429034 61 fields · synced May 18, 2026
- EUDAMED c3696168-b50a-4c83-a354-37d010ca4acd 61 fields · synced May 19, 2026