Apolipoprotein A1 Assay Kit (Immunoturbidimetric Method)

EUDAMED

Class IVD General (EU MDR)

Ref DTSH060509Model R1: 60 mL×2; R2: 15 mL×2

by Da Te Bioengineering Technology Co., LTD.

Identity

Device Name: Apolipoprotein A1 Assay Kit (Immunoturbidimetric Method) EUDAMED
Model / Reference: R1: 60 mL×2; R2: 15 mL×2 EUDAMED
DTSH060509 EUDAMED

Identifiers

Primary DI / UDI-DI: 06975225462190 EUDAMED
Basic UDI-DI: B-06975225462190 EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I 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 A-I (Apo A1) IVD, reagent

Apolipoprotein A1 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 A-I (Apo A1) 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-06975225462190	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 f7db6524-e800-4cca-8cbc-df0ddd6f5ccc 61 fields · synced Jun 18, 2026