LDL-Cholesterol Kit (Direct Method)

Model / Reference

105-000836-00、105-000875-00、105-004611-00, 105-004611-00

Primary DI / UDI-DI

06944904050898

Basic UDI-DI

694490400045LDL-C******2D

EMDN Code

W01010221 Low density lipoprotein cholesterol including sd-ldl

Device Class

Class B

Market of Registration

Germany

EUDAMED SRN

CN-MF-000014156

Authorised representative

Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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  Class II

  FDA 510(k) K182636 Active Cleared 10 Jan 2019

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  Class II

  FDA 510(k) K221300 Active Cleared 29 Sep 2022

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• Diagnostic Ultrasound System

  Class IIa

  CE/MDR

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  Class A

  CE/IVDR

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