FER Calibrator

Device Name

Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)、FER Calibrator

Model / Reference

105-006175-00、105-002244-00、105-002245-00、105-006176-00、105-004505-00、105-004506-00、105-002311-00, 105-002311-00

Primary DI / UDI-DI

06944904031545

Basic UDI-DI

69449040004JFER********AD

EMDN Code

W0102152206 Anaemia related/vitamin 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

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  Class D

  CE/IVDR V76 044751 0357 Active Valid to Oct 2031

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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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  Class IIa

  CE/MDR

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  Class A

  CE/IVDR

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