Would appear FDA also already aware of CE for u guys.
https://www.fdanews.com/articles/192516-resapp-gains-ce-mark-for-respiratory-disease-diagnostic-appFDAnews Device Daily BulletinMedical Devices / Submissions and ApprovalsResApp Gains CE Mark for Respiratory Disease Diagnostic App
Aug. 28, 2019ResApp has earned the CE Mark for its ResAppDx-EU, a smartphone-based diagnostic test for acute pediatric respiratory disease.
The CE Mark was supported by data from a pediatric clinical study showing that the app’s cough-based diagnosis algorithms had “excellent agreement with a clinical diagnosis,” the company said.
The mobile software app is intended for use by clinicians to diagnose lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children