Certifications and Compliance

FDA - 510(k) Premarket Notification

FDA 510(k) Database | FDA

Health Canada Medical Devices Active Licence

  • Licence No.: 101550
  • Type: System
  • Device class: 2
  • Device first issue date: 2018-08-02
  • Licence name: DERMADRY
Health Canada

CE marking Certificate - ECM21MDD023

Certificate by TÜV-SÜD

Intertek Certificate of Registration

Quality Management System - ISO 13485:2016 - MDSAP

Intertek Certificate

CB Test Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
  • IEC 60601-1:2005
  • IEC 60601-1:2005/AMD1:2012
  • IEC 60601-1:2005/AMD2:2020
  • IEC 60601-1-6:2010
  • IEC 60601-1-6:2010/AMD1:2013
  • IEC 60601-1-6:2010/AMD2:2020
  • IEC 60601-1-11:2015
  • IEC 60601-1-11:2015/AMD1:2020
Certificate by TÜV-SÜD

Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
    ANSI/AAMI ES60601-1:2005/A2:2021
  • CSA C22.2 No. 60601-1-6:2011/A2:2021-08
  • CSA C22.2 No. 60601-1:2014/A2:2022-03
  • CSA C22.2 No. 60601-1-11:2015/A1:2021-09
  • Exclusions: All the above excluding Biocompatibility (cl. 11.7) and EMC (cl. 17)
Certificate by TÜV-SÜD

Australian Register of Therapeutic Goods Certificate

Australian Certificate Australian Certificate