Troponin I Calibrators

Device Name

Troponin I(CLIA)、Troponin I Calibrators

Model / Reference

105-005659-00、105-005676-00、105-005910-00, 105-005910-00

Primary DI / UDI-DI

06944904065458

Basic UDI-DI

69449040004L-TnI*******5G

EMDN Code

W0102152204 Cardiac marker standards and calibrators

Device Class

Class C

Market of Registration

Germany

EUDAMED SRN

CN-MF-000014156

Authorised representative

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

• HBsAg Positive Control

  Class D

  CE/IVDR V76 044751 0357 Active Valid to Oct 2031

• DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

  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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  Class II

  FDA 510(k) K261617 Active Cleared 8 Oct 2026

• Diagnostic Ultrasound System

  Class IIa

  CE/MDR

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  Class A

  CE/IVDR

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