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Low-Density Lipoprotein Cholesterol Assay Kit (Direct Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060408Model R1: 45 mL×1; R2: 15 mL×1
Identity
- Device Name
- Low-Density Lipoprotein Cholesterol Assay Kit (Direct Assay) EUDAMED
- Model / Reference
- R1: 45 mL×1; R2: 15 mL×1 EUDAMEDDTSH060408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460516 EUDAMED
- Basic UDI-DI
- B-06975225460516 EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL 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
Low-Density Lipoprotein Cholesterol Assay Kit (Direct Assay) 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-06975225460516 | 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 b8486491-fc8f-4c71-b4c9-63c6383d6d34 61 fields · synced Jun 17, 2026