Regulatory
Quality Management System
ISO 13485:2016 & EN ISO 13485:2016
Therapeutic Goods Administration
ProEX and ProEX Mobile ARTG number 305324
GEIS ARTG number 283581
For all Visionflex ARTG entries click here
INTERNATIONAL REGULATORY REGISTRATIONS AND APPROVALS
U.S. Food & Drug Administration
ProEX and ProEX Mobile listing number D298044
GEIS listing number D299774
For all Visionflex listings please click here
Canada
Click here for ProEX registration
European Union
Click here for ProEX, ProEX Mobile and GEIS registration
Vietnam
Click here for the devices approved list
Saudi Arabia
