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Low-Density Lipoprotein Cholesterol Assay Kit (Direct Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060412Model R1: 80 mL×3; R2: 80 mL×1Ref DTSH060406Model R1: 21 mL×1; R2: 7 mL×1Ref DTSH060403Model R1: 60 mL×4; R2: 20 mL×4Ref DTSH060407Model R1: 30 mL×1; R2: 10 mL×1Ref DTSH060410Model R1: 60 mL×2; R2: 20 mL×2Ref DTSH060409Model R1: 30 mL×3; R2: 30 mL×1
Identity
- Device Name
- Low-Density Lipoprotein Cholesterol Assay Kit (Direct Assay) EUDAMED
- Model / Reference
- R1: 80 mL×3; R2: 80 mL×1 EUDAMEDDTSH060412 EUDAMEDR1: 21 mL×1; R2: 7 mL×1 EUDAMEDDTSH060406 EUDAMEDR1: 60 mL×4; R2: 20 mL×4 EUDAMEDDTSH060403 EUDAMEDR1: 30 mL×1; R2: 10 mL×1 EUDAMEDDTSH060407 EUDAMEDR1: 60 mL×2; R2: 20 mL×2 EUDAMEDDTSH060410 EUDAMEDR1: 30 mL×3; R2: 30 mL×1 EUDAMEDDTSH060409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460561 EUDAMED06975225460493 EUDAMED06975225460554 EUDAMED06975225460509 EUDAMED06975225460530 EUDAMED06975225460523 EUDAMED
- Basic UDI-DI
- B-06975225460561 EUDAMEDB-06975225460493 EUDAMEDB-06975225460554 EUDAMEDB-06975225460509 EUDAMEDB-06975225460530 EUDAMEDB-06975225460523 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-06975225460561 | 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 (6)
- EUDAMED ee448999-0eb8-48ab-bef4-5674aea01b1a 61 fields · synced Jul 25, 2026
- EUDAMED d0dc74c1-e3c9-4764-b0a3-e6b63941cbdc 61 fields · synced May 16, 2026
- EUDAMED 6dc63691-e656-40df-af09-6609e582be22 61 fields · synced May 17, 2026
- EUDAMED 3aa85991-9d86-4a24-a578-f32be1a5af65 61 fields · synced May 17, 2026
- EUDAMED f4ad66be-c560-408e-b1cc-75c4c71d51d5 61 fields · synced May 18, 2026
- EUDAMED 1bbac64e-c9c8-4c07-b18f-58f9e613c085 61 fields · synced May 18, 2026