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.
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) valid through July 2022.