获证管理体系

EN ISO 13485 和 IVDD Annex IV.3

证书持有人: BEIJING LEPU MEDICAL TECHNOLOGY CO.,LTD.

认证标识号码: 9000009819

证书持有人的管理体系符合下列标准:
  • EN ISO 13485
  • IVDD Annex IV.3
证书范围:
  • 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

由持证人提供的进一步资料: 持证人没有提供进一步资料。
联系持证人: BEIJING LEPU MEDICAL TECHNOLOGY
CO.,LTD.
Building 7-1, No. 37,
Chaoqian Road, Changping District
Beijing
102200 Beijing
中国