Zertifizierte Managementsysteme

EN ISO 13485 und IVDD Annex IV.3

Zertifikatsinhaber: BEIJING LEPU MEDICAL TECHNOLOGY CO.,LTD.

Prüfzeichennummer: 9000009819

Das Management System des Zertifikatsinhabers entspricht den Normen:
  • EN ISO 13485
  • IVDD Annex IV.3
Geltungsbereich der Zertifikate:
  • 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

Weitere Informationen des Zertifikatsinhabers: Der Zertifikatsinhaber hat keine weiteren Informationen angegeben.
Kontakt zum Zertifikatsinhaber: BEIJING LEPU MEDICAL TECHNOLOGY
CO.,LTD.
Building 7-1, No. 37,
Chaoqian Road, Changping District
Beijing
102200 Turku ja Pori
China