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High-Density Lipoprotein Cholesterol Assay Kit (Direct Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060312Model R1: 80 mL×3; R2: 80 mL×1Ref DTSH060307Model R1: 30 mL×1; R2: 10 mL×1Ref DTSH060310Model R1: 60 mL×2; R2: 20 mL×2Ref DTSH060309Model R1: 30 mL×3; R2: 30 mL×1Ref DTSH060306Model R1: 21 mL×1; R2: 7 mL×1Ref DTSH060308Model R1: 45 mL×1; R2: 15 mL×1
Identity
- Device Name
- High-Density Lipoprotein Cholesterol Assay Kit (Direct Assay) EUDAMED
- Model / Reference
- R1: 80 mL×3; R2: 80 mL×1 EUDAMEDDTSH060312 EUDAMEDR1: 30 mL×1; R2: 10 mL×1 EUDAMEDDTSH060307 EUDAMEDR1: 60 mL×2; R2: 20 mL×2 EUDAMEDDTSH060310 EUDAMEDR1: 30 mL×3; R2: 30 mL×1 EUDAMEDDTSH060309 EUDAMEDR1: 21 mL×1; R2: 7 mL×1 EUDAMEDDTSH060306 EUDAMEDR1: 45 mL×1; R2: 15 mL×1 EUDAMEDDTSH060308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460486 EUDAMED06975225460424 EUDAMED06975225460455 EUDAMED06975225460448 EUDAMED06975225460417 EUDAMED06975225460431 EUDAMED
- Basic UDI-DI
- B-06975225460486 EUDAMEDB-06975225460424 EUDAMEDB-06975225460455 EUDAMEDB-06975225460448 EUDAMEDB-06975225460417 EUDAMEDB-06975225460431 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-06975225460486 | 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 3196e32c-3630-4e3e-8ce7-146649204503 61 fields · synced Jul 30, 2026
- EUDAMED f867b8a1-c4a3-4181-9f45-80d63e41792a 61 fields · synced May 16, 2026
- EUDAMED 79049157-4c46-40af-88fd-caf23ba86c88 61 fields · synced May 17, 2026
- EUDAMED 50df1d57-dfa0-4e27-b1fa-3ff096a77a07 61 fields · synced May 17, 2026
- EUDAMED d5e81f98-cc1a-4ade-b364-7185f342dbd9 61 fields · synced May 17, 2026
- EUDAMED 0fced8ff-910c-4261-9455-82b1a0b1e93e 61 fields · synced May 18, 2026