Regulatory
Visionflex is committed to designing industry-leading medical devices that are effective, elegant, easy to use, and conform to the most stringent customer and regulatory requirements. We proudly maintain a certified ISO 13485 Quality Management System through a systemic approach to risk. Our devices have been approved by the Australian Therapeutic Goods Administration as well as multiple international agencies.
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
Click here for GEIS registration
European Union
Click here for ProEX, ProEX Mobile and GEIS registration
Vietnam
Click here for the devices approved list
Saudi Arabia
