top of page

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.

ISO-Logo.jpg

ISO Quality certificate

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

Free Sale Certificate Seal.png

Certificate of Free Sale

HeartTrends® has a Free Sale Certificate for use in countries worldwide valid through 28 March 2024

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 #14470402) valid through 31 March 2024.

Health_Sciences_Authority_(Singapore)

Health Sciences Authority Singapore

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

bottom of page