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Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030806Model R1: 80 mL×3; R2: 20 mL×4Ref DTSH030805Model R1: 90 mL×2; R2: 15 mL×4Ref DTSH030802Model R1: 21 mL×1; R2: 7 mL×1Ref DTSH030801Model R1: 60 mL×3; R2: 20 mL×3Ref DTSH030803Model R1: 60 mL×1; R2: 20 mL×1
Identity
- Device Name
- Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 80 mL×3; R2: 20 mL×4 EUDAMEDDTSH030806 EUDAMEDR1: 90 mL×2; R2: 15 mL×4 EUDAMEDDTSH030805 EUDAMEDR1: 21 mL×1; R2: 7 mL×1 EUDAMEDDTSH030802 EUDAMEDR1: 60 mL×3; R2: 20 mL×3 EUDAMEDDTSH030801 EUDAMEDR1: 60 mL×1; R2: 20 mL×1 EUDAMEDDTSH030803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225464347 EUDAMED06975225464323 EUDAMED06975225464248 EUDAMED06975225464309 EUDAMED06975225464262 EUDAMED
- Basic UDI-DI
- B-06975225464347 EUDAMEDB-06975225464323 EUDAMEDB-06975225464248 EUDAMEDB-06975225464309 EUDAMEDB-06975225464262 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
Category: Apolipoprotein B (Apo B) IVD, reagent
Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric 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-06975225464347 | 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 (5)
- EUDAMED 808ac5f8-232c-4ee2-8ef3-3f4d33fdb17e 61 fields · synced Sep 17, 2026
- EUDAMED 30853bc7-486d-48e2-b67d-91828947c341 61 fields · synced May 18, 2026
- EUDAMED a31ec6de-ed29-44d6-9b2a-1db67d2a3ab2 61 fields · synced May 18, 2026
- EUDAMED 01ca1b52-5bc4-476d-bafa-982ecb658c48 61 fields · synced May 18, 2026
- EUDAMED ae439b77-4b6f-481f-814e-f3ee49b9ca8f 61 fields · synced May 19, 2026