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DEVICE DETAILS

NAME OF DEVICESAMSUNG ECG APP
ESTABLISHMENT NAMESAMSUNG MALAYSIA ELECTRONICS (SME) SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB9718423-113876
BRAND NAMESAMSUNG HEALTH MONITOR
MEDICAL DEVICE CATEGORYMD 1111 - Software
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe Samsung ECG Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG for adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment.
DEVICE INTENDED PURPOSEThe Samsung ECG App is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG for adults 22 years and older.
VALIDITY DATE OF REGISTRATION01/01/2023 - 31/12/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1SAMSUNG ECG APPECG APP
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