CE Medical Certification

HeartTrends® is CE-marked (0344) by the European Union for the following product category: Software-based medical devices for diagnostics-aid of ischemic heart diseases using Heart Rate variability analysis - valid through 31 December 2028 (via EU Extension of Validity Regulation 2023/607)

ISO Quality certificate

Lev El Diagnostics of Heart Diseases Ltd. complies with international standards of quality EN ISO 13485:2016 valid through March 2025

Certificate of Free Sale

HeartTrends® has a Free Sale Certificate for use in countries worldwide

Israel Ministry of Health

HeartTrends® is approved by the Israel Ministry of Health for medical device sales & marketing in Israel (certificate #14470402) valid through 31 December 2024

Costa Rica Ministry of Health

HeartTrends® has received the Certificate of Registration of Biomedical Equipment from the Costa Rica Ministry of Health valid through 22 January 2029

Philippines FDA & Department of Health

HeartTrends® has received FDA approval from the Philippines Department of Health for sales in the Philippines

Health Sciences Authority Singapore

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