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Lipid Particle Analyzer Calibrator

EUDAMED

Class IVD General (EU MDR)

Ref VL9204AModel 2×0.5 mL

by Jiangxi Medicalsystem Biological Technology Co., Ltd.

Identity

Trade Name: Lipid Particle Analyzer Calibrator EUDAMED
Device Name: Lipid Particle Analyzer Calibrator EUDAMED
Model / Reference: 2×0.5 mL EUDAMED
VL9204A EUDAMED

Identifiers

Primary DI / UDI-DI: 06978945080958 EUDAMED
Basic UDI-DI: B-06978945080958 EUDAMED
EMDN Code: W01010205 CHOLESTEROL EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Total cholesterol lipid IVD, reagent

Lipid Particle Analyzer Calibrator by Jiangxi Medicalsystem Biological Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
EUDAMED SRN: CN-MF-000050651
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED dd54b703-6e49-40bf-9563-6c24fc803f41 61 fields · synced Jul 8, 2026