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.
