Global Regulatory Footprint

Dario products are approved for marketing in the following countries:

     Country/Area

  By

USA

FDA 510(K)

European Union

CE mark

Canada

Health Canada

Australia

TGA

New Zealand

WAND

Personalized Approach,
Global Reach

The Dario Blood Glucose Monitoring System has US FDA clearance and approval from the European CE, Health Canada, and Australia’s TGA.
Commercially available in the United States, Canada, the United Kingdom, Germany, Italy, and Australia, DarioHealth is rapidly expanding into new geographic markets and chronic conditions.