Regulatory

Quality Management System
ISO 13485:2016 & EN ISO 13485:2016

   

Certificate MD 646035

Certificate ISO 13485

 

Therapeutic Goods Administration

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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

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ProEX and ProEX Mobile listing number D298044

GEIS listing number D299774

For all Visionflex listings please click here

 

Canada

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Click here for ProEX registration

 

European Union

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Vietnam

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Click here for the devices approved list

 

Saudi Arabia

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