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Total Cholesterol Assay Kit (Oxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060103Model R: 90 mL×4Ref DTSH060107Model R: 60 mL×6Ref DTSH060105Model R: 60 mL×2
Identity
- Device Name
- Total Cholesterol Assay Kit (Oxidase Method) EUDAMED
- Model / Reference
- R: 90 mL×4 EUDAMEDDTSH060103 EUDAMEDR: 60 mL×6 EUDAMEDDTSH060107 EUDAMEDR: 60 mL×2 EUDAMEDDTSH060105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461278 EUDAMED06975225461261 EUDAMED06975225461230 EUDAMED
- Basic UDI-DI
- B-06975225461278 EUDAMEDB-06975225461261 EUDAMEDB-06975225461230 EUDAMED
- EMDN Code
- W01010205 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
Category: Total cholesterol lipid IVD, reagent
Total Cholesterol Assay Kit (Oxidase Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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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-06975225461278 | 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 (3)
- EUDAMED 6c31f226-451d-4510-b114-e742d5d9ca4d 61 fields · synced Sep 18, 2026
- EUDAMED 92f00d9c-fdd8-4e66-80e3-15096d94535e 61 fields · synced May 16, 2026
- EUDAMED e4864db8-7b63-42bc-8168-8080c0f15510 61 fields · synced May 18, 2026