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Certifications & 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 60601-1-6:2010
  • IEC 60601-1-6:2010/AMD1:2013
  • IEC 60601-1-11:2015

Certificate by TÜV-SÜD


Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
  • CAN/CSA-C22.2 No. 60601-1:2014 excluding Biocompatibility (CI. 11.7) and EMC (clause 17)
  • CAN/CSA-C22.2 No. 60601-1-6:2011/A1:2015-10
  • CAN/CSA-C22.2 No. 60601-1-11:2015
  • ANSI/AAMI ES60601-1:2005/A1:2012-08, excluding Biocompatibility (CI. 11.7) and EMC (clause 17)

Certificate by TÜV-SÜD


Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
  • CAN/CSA-C22.2 No. 60601-1:2014 excluding Biocompatibility (CI. 11.7) and EMC (clause 17)
  • CAN/CSA-C22.2 No. 60601-1-6:2011/A1:2015-10
  • CAN/CSA-C22.2 No. 60601-1-11:2015
  • ANSI/AAMI ES60601-1:2005/A1:2012-08, excluding Biocompatibility (CI. 11.7) and EMC (clause 17)

Certificate by TÜV-SÜD


Australian Register of Therapeutic Goods Certificate


Australian Certificate

Australian Certificate