Prealbumin Assay Kit (Immunoturbidimetric Method)

EUDAMED

Class IVD General (EU MDR)

Ref DTSH021306CModel R1: 80 mL×3; R2: 20 mL×4; Calibrator: 1 mL×1

by Da Te Bioengineering Technology Co., LTD.

Identity

Device Name: Prealbumin Assay Kit (Immunoturbidimetric Method) EUDAMED
Model / Reference: R1: 80 mL×3; R2: 20 mL×4; Calibrator: 1 mL×1 EUDAMED
DTSH021306C EUDAMED

Identifiers

Primary DI / UDI-DI: 06975225463630 EUDAMED
Basic UDI-DI: B-06975225463630 EUDAMED
EMDN Code: W0102010405 LIPOPROTEIN ( A ) EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

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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Also classified as Apolipoprotein B (Apo B) IVD, reagent.

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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-06975225463630	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 d162c43d-fa3b-4673-b871-40033e7fe7fa 61 fields · synced Jun 18, 2026