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.


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DEVICE DETAILS

NAME OF DEVICESAMSUNG SLEEP APNEA FEATURE
ESTABLISHMENT NAMESAMSUNG MALAYSIA ELECTRONICS (SME) SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB4417025-208398
BRAND NAMESAMSUNG HEALTH MONITOR
MEDICAL DEVICE CATEGORYMD 1111 - Software
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
DEVICE INTENDED PURPOSEThis feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions over a two-night monitoring period, for adult users 22 years or older.
VALIDITY DATE OF REGISTRATION31/07/2025 - 30/07/2030

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1SAMSUNG SLEEP APNEA FEATURESLEEP APNEA FEATURE
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