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Total Cholesterol (CHOL) Kit (Enzymatic Method)

EUDAMED

Class IVD General (EU MDR)

Ref 01.09.02.10.EC.01

Identity

Device Name: Total Cholesterol (CHOL) Kit (Enzymatic Method) EUDAMED
Model / Reference: 01.09.02.10.EC.01 EUDAMED

Identifiers

Primary DI / UDI-DI: 06941967206040 EUDAMED
Basic UDI-DI: B-06941967206040 EUDAMED
EMDN Code: W01010205 CHOLESTEROL EUDAMED

Classification

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

Total Cholesterol (CHOL) Kit (Enzymatic Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Total cholesterol lipid IVD, reagent.

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DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
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Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Zybio Inc.
EUDAMED SRN: CN-MF-000003349
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED 141cc1a0-d446-4ce0-80b7-ecc7856965ec 61 fields · synced Jun 19, 2026