Apolipoprotein A1 Reagent Kit（immunoturbidimetric Method）

EUDAMED

Class IVD General (EU MDR)

Ref 3021155Model R1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL

by Dirui Industrial Co., Ltd

Identity

Trade Name: APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
Device Name: APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
Model / Reference: R1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL EUDAMED
3021155 EUDAMED

Identifiers

Primary DI / UDI-DI: 06942202261145 EUDAMED
Basic UDI-DI: B-06942202261145 EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Austria 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 Reagent Kit（immunoturbidimetric Method） by Dirui Industrial 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-06942202261145	Class IVD General	Active

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Manufacturer

Manufacturer: Dirui Industrial Co., Ltd
EUDAMED SRN: CN-MF-000001891
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (1)

EUDAMED 91e6cccc-b25b-431b-a506-fbf1bd0f20b3 61 fields · synced Jun 20, 2026