Apolipoprotein A1 Kit (Immunoturbidimetric Assay)

EUDAMED

Class IVD General (EU MDR)

Ref /

by Shanghai Kehua Bio-engineering Co., Ltd.

Identity

Device Name: Apolipoprotein A1 Kit (Immunoturbidimetric Assay) EUDAMED
Model / Reference: / EUDAMED

Identifiers

Primary DI / UDI-DI: D-KHB10197 EUDAMED
Basic UDI-DI: B-KHB10197 EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

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 Kit (Immunoturbidimetric Assay) by Shanghai Kehua Bio-engineering 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-KHB10197	Class IVD General	Active

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Manufacturer

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
EUDAMED SRN: CN-MF-000026756
Authorised Representative: QbD RepS BV BE-AR-000000040

Sources (1)

EUDAMED 46ab72c1-aa38-45eb-acd4-b0453acccf2b 61 fields · synced Jul 20, 2026