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TC Total Cholesterol Test Kit

EUDAMED

Class IVD General (EU MDR)

Ref Ir095

by Kangsheng Information Technology (Hangzhou) Co. LTD

Identity

Device Name: TC Total Cholesterol Test Kit EUDAMED
Model / Reference: Ir095 EUDAMED

Identifiers

Primary DI / UDI-DI: D-697994388Ir0953ZFV EUDAMED
Basic UDI-DI: B-697994388Ir0953ZFV EUDAMED
EMDN Code: W01010205 CHOLESTEROL EUDAMED

Classification

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

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Total cholesterol lipid IVD, reagent

TC Total Cholesterol Test Kit by Kangsheng Information Technology (Hangzhou) Co. LTD — Class IVD General — IVDD — listed in EUDAMED

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Also classified as Total cholesterol lipid IVD, reagent.

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
EUDAMED SRN: CN-MF-000053775
Authorised Representative: Crealkraft GmbH DE-AR-000049943

Sources (1)

EUDAMED e538f58d-c74a-4ead-b5cd-f1f1dfe797cd 61 fields · synced Jul 10, 2026