Certification and Compliance
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)