GETEMED CardioDay® - HSA Registration DE0510470
Access comprehensive regulatory information for GETEMED CardioDay® in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510470 and owned by GETEMED Medizin und Informationstechnik AG. The device was registered on March 14, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
CardioDay is for the acquisition, analysis, edit, review, report, & storage of ambulatory & multi-parameter ECG data. Automated analysis results are intended to assist the physician in the interpretation of the recorded data, not intended as a substitute for the physician overread of the recorded ECG data. Intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital/clinic environment. For adult & pediatric patients.Provides user arrhythmia study & Holter analysis capabilities. Data acquired may be used for: Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances,Evaluation of symptoms that may be due to myocardial ischemia,Detection of ECG events that alter prognosis in certain forms of heart disease,Detection & analysis of pacemaker function & failure,Determination of cardiac response to lifestyle,Evaluation of therapeutic interventions,Investigations in epidemiology & clinical trials.