Certified Management Systems

EN ISO 13485 y IVDD Annex IV.3

Certificado Titular: BEIJING LEPU MEDICAL TECHNOLOGY CO.,LTD.

Número de logotipo: 9000009819

The certificate holder's Sistema de Gestión corresponds to standards:
  • EN ISO 13485
  • IVDD Annex IV.3
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, Blood Analytics, Genetic Testing,
    Disease Status, Infectious Disease, Cancer Markers and Blood Glucose 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

Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: BEIJING LEPU MEDICAL TECHNOLOGY
CO.,LTD.
Building 7-1, No. 37,
Chaoqian Road, Changping District
Beijing
102200 Beijing
China