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

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New Zealand Medicines and Medical Safety Authority

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European Conformity

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Australia's Regulatory Authority for Therapeutic Goods

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Brazilian Health Regulatory Agency

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




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