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  • Certified Management Systems

    • Management Systems

      EN ISO 13485 and IVDD Annex IV.3

    • Certificate Holder

      BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.

    • Test Mark Number

      9000009819

    Certificate scopes

    • EN ISO 13485

      Design and Development, Manufacture, Distribution and Service of In-vitro Diagnostic Analyzers and In-vitro Diagnostic Test Kits used in Detection of Cardiac Markers, Coagulation, Genetic Testing, Disease Status, Infectious Disease, Cancer Markers, Blood Glucose Monitoring including Meters and Strips and Blood Glucose, Ketone Body and Uric Acid Monitoring including Meters and Strips including Home Use

    • IVDD Annex IV.3

      - Blood Glucose Monitoring Systems
      - Blood Glucose Test Strips
      - SARS-CoV-2 Antigen Rapid Tests for self-testing
      - Blood Glucose, Ketone and Uric Acid System
      - Blood Glucose, Ketone and Uric Acid Meters
      - Ketone Test Strips
      - Uric Acid Test Strips

    Certificates for these Management Systems

    Contact to the certificate holder

    BEIJING LEPU MEDICAL TECHNOLOGY
    CO., LTD.
    Building 7-1, No. 37,
    Building 7-1, No. 37 Chaoqian Road, Changping District,
    102200 Beijing
    China (Mainland)