FDA - 510(k) Premarket Notification

• Device Name: Dermadry
• 510(K) Number: K192749
• Date of issue: 02/10/2020
• Regulatory Class: Class II

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

Intertek Certificate of Registration

Quality Management System - ISO 13485:2016 - MDSAP

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 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 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)

Australian Register of Therapeutic Goods Certificate