This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICESAMSUNG ECG APP
ESTABLISHMENT NAMESAMSUNG MALAYSIA ELECTRONICS (SME) SDN. BHD.
REGISTRATION NOGB9718423-113876
BRAND NAMESAMSUNG HEALTH MONITOR
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
Back