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.


DEVICE DETAILS

NAME OF DEVICEACULIFE® FINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEACULIFE (M) SDN BHD
REGISTRATION NOGC1534922-89773
BRAND NAMEACULIFE
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONAculife® Fingertip Pulse Oximeter is a non-invasive portable device intended for measuring the level of oxygen saturation (SpO2) and Pulse Rate (PR). It is indicated to be used at home as well as in clinical institutions for the purpose of quick diagnosis on respiratory function of patients. Aculife® Fingertip Pulse Oximeter is suitable to be used on both children and adults. Aculife® Fingertip Pulse Oximeter able to measure SpO2 to indicate the amount of oxygen-carrying haemoglobin in the blood relative to the amount of haemoglobin not carrying oxygen and Pulse Rate to indicate the heart beat per minute. Aculife® Fingertip Pulse Oximeter is a reusable device and is non-sterile. It is small in size, low power consumption, convenient operation and portability. It only required patient to place one finger into fingertip photoelectric sensor for diagnosis, and the display screen will directly show measured value of haemoglobin saturation. It has been proved in clinical experiments that it possesses rather high precision and repeatability.
DEVICE INTENDED PURPOSEIntended for measuring the level of oxygen saturation (SpO2) and Pulse Rate.
VALIDITY DATE OF REGISTRATION01/04/2022 - 31/03/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1ACULIFE® FINGERTIP PULSE OXIMETERA3