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 DEVICEECG APP
ESTABLISHMENT NAMEHUAWEI TECHNOLOGIES (MALAYSIA) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC9742522-109058
BRAND NAMEHUAWEI
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe ECG app records the user's single-lead ECG, classifies sinus rhythm or atrial fibrillation based on the ECG waveform. Users can share the ECG recordings, rhythm classifications and accompany symptoms with a qualified healthcare professional. The ECG app is intended to be used by people aged 18 years and over.
DEVICE INTENDED PURPOSEThe ECG app records the user's single-lead ECG, classifies sinus rhythm or atrial fibrillation based on the ECG waveform.
VALIDITY DATE OF REGISTRATION15/11/2022 - 14/11/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1ECG APPECG-1
Back