IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent

EUDAMED

Class IVD General (EU MDR)

Ref 446410

by Beckman Coulter Inc.

Identity

Trade Name: IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent EUDAMED
Device Name: IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent EUDAMED
Model / Reference: 446410 EUDAMED

Identifiers

Primary DI / UDI-DI: D-446410PQ EUDAMED
Basic UDI-DI: B-446410PQ EUDAMED
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

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

IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent by Beckman Coulter, Inc. — 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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Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General

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-446410PQ	Class IVD General	Active

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Manufacturer

Manufacturer: Beckman Coulter Inc.
EUDAMED SRN: US-MF-000010288
Authorised Representative: Beckman Coulter Ireland Inc. IE-AR-000000886

Sources (1)

EUDAMED af141b14-19da-4637-82e8-c6bcca50b9e1 61 fields · synced Jul 9, 2026