Cardioskin

Cardioskin Application is an accessory of a medical device that enables acquisition, recording, storage, transmission, and display of 15-leads electrocardiogram (ECG) in order to analyze potential cardiac pathological abnormalities.Cardioskin Application is available:- In Europe, as a class IIa medical device accessory. It is a regulated health product that bears, under the European regulation of medical devices (MDR EU 2017/745), the CE 2797 mark.Cardioskin Application cannot be used alone, it is part of the Cardioskin system and federal law restricts this device to sale by or on the order of a physician.The application is intended for healthcare professionals and their patients over 15 years in Europe.Users are reminded to:- Carefully read the instructions supplied with the product before use;- Consult a healthcare professional if in doubt and before making medical decisions.More information available at: https://www.bioserenity.com/qualityThis application is manufactured by BioSerenity, ICM-iPEPS, 47 boulevard de l’hôpital, 75013 Paris - FRANCE.