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Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030802CModel R1: 21 mL×1; R2: 7 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 2
Identity
- Device Name
- Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 21 mL×1; R2: 7 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 2 EUDAMEDDTSH030802C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225464255 EUDAMED
- Basic UDI-DI
- B-06975225464255 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) 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
Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method) 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-06975225464255 | 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 c84f775e-1e90-4b24-8c11-a1f22f64bec6 61 fields · synced Jun 19, 2026