Regulatory

CE Medical Certification

HeartTrends® is CE-marked (0344) for the following product category: Software based medical devices for diagnostics-aid of ischemic heart diseases using Heart Rate variability analysis. (Valid through March 2024)

ISO Quality

Lev El Diagnostics of Heart Diseases Ltd. complies with international standards of quality EN ISO 13485:2016 (Valid through March 2022)

Health Sciences Authority Singapore

HeartTrends® has received HSA approval from the Health Sciences Authority for sales in Singapore.

Israel Ministry of Health

HeartTrends® is approved by the Israeli Ministry of Health for medical device sales & marketing in Israel (certificate #14470401).

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Product of Lev-El Diagnostics Ltd. ©2020