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High-Density Lipoprotein Cholesterol Assay Kit (Direct Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060311Model R1: 60 mL×3; R2: 60 mL×1
Identity
- Device Name
- High-Density Lipoprotein Cholesterol Assay Kit (Direct Assay) EUDAMED
- Model / Reference
- R1: 60 mL×3; R2: 60 mL×1 EUDAMEDDTSH060311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460462 EUDAMED
- Basic UDI-DI
- B-06975225460462 EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL 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
High-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-06975225460462 | 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 712877dd-1ea0-48f6-b891-31616af3a339 61 fields · synced Jun 19, 2026