Regulatory

HeartTrends CE European Medical certificate

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.

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ISO Quality certificate

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

AMAR (Israel) certificate for HeartTrends

Israel Ministry of Health

HeartTrends® is approved by the Israeli Ministry of Health for medical device sales & marketing in Israel (certificate #14470401) valid through July 2022.

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Health Sciences Authority Singapore

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

Product of Lev-El Diagnostics Ltd. ©2020