HSA · registration DE0510470GETEMED CardioDay®
- Registration number
- DE0510470
- Model name
- CardioDay
- Model identifier
- CardioDay V2.7
- Registration date
- March 14, 2025
- Source update date
- March 09, 2026
- Risk class
- Class B
- Product owner
- GETEMED Medizin und Informationstechnik AG
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
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.
- Product owner address
- Oderstrabe 77, 14513 Teltow, Germany
- Registrant address
- 11 North Buona Vista Drive, #11-07, The Metropolis, Singapore 138589
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.