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Prealbumin Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH021305Model R1: 90 mL×2; R2: 15 mL×4Ref DTSH021301Model R1: 60 mL×3; R2: 20 mL×3Ref DTSH021307CModel R1: 45 mL×3; R2: 45 mL×1; Calibrator: 1 mL×1
Identity
- Device Name
- Prealbumin Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 90 mL×2; R2: 15 mL×4 EUDAMEDDTSH021305 EUDAMEDR1: 60 mL×3; R2: 20 mL×3 EUDAMEDDTSH021301 EUDAMEDR1: 45 mL×3; R2: 45 mL×1; Calibrator: 1 mL×1 EUDAMEDDTSH021307C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463609 EUDAMED06975225463586 EUDAMED06975225463579 EUDAMED
- Basic UDI-DI
- B-06975225463609 EUDAMEDB-06975225463586 EUDAMEDB-06975225463579 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
Prealbumin Assay Kit (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-06975225463609 | 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 dd03324f-598d-4b80-8b00-c99dcd7b73fa 61 fields · synced Jul 21, 2026
- EUDAMED f5f89332-b907-45bf-b1d8-cd5382013697 61 fields · synced May 18, 2026
- EUDAMED afef9688-6cb7-41dd-b4e6-c8b189f1aa12 61 fields · synced May 18, 2026