The MoleScope device adheres to regulations set out by the following health authorities:

New Zealand flag

New Zealand Medicines and Medical Safety Authority

EU flag

European Conformity

Australian flag

Australia's Regulatory Authority for Therapeutic Goods

Brazilian flag

Brazilian Health Regulatory Agency

HIPAA Seal of Compliance” width=

 

ISO image

MoleScope devices Design, Manufacture, and Distribution, hold ISO 13485:2016 Quality System Standard certification.

 

 

 

*MoleScope is FDA Registered                                           *Not available for sale in Canada