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 DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMESYMBIOMED SDN. BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC287471101918
BRAND NAMEALVITAL
MEDICAL DEVICE CATEGORYMD 1300 - MONITORING DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONFINGER OXIMETRY FOR NON-INVASIVE SPOT CHECKING AND CONTINUOUS MONITORING IN HOME AND PROFESSIONAL CARING ENVIRONMENT, AND TRANSPORT AND MOBILE ENVIRONMENT. IT IS DESIGNED FOR FINGERS.
DEVICE INTENDED PURPOSEAT101 IS INTENDED FOR MEASURING FUNCTIONAL OXYGEN SATURATION OF ARTERIAL HEMOGLOBIN (SPO2) AND PULSE RATE FOR BOTH ADULTS AND CHILDREN AS NON-INVASIVE SPOT CHECKING AND CONTINUOUS MONITORING IN HOME AND PROFESSIONAL CARING ENVIRONMENT, AND TRANSPORT AND MOBILE ENVIRONMENT. IT IS DESIGNED FOR FINGERS BETWEEN 0.8CM AND 2.3CM (0.3 INCH ~ 0.9 INCH) AND INTEND FOR PATIENTS DURING NO-MOTION CONDITION
VALIDITY DATE OF REGISTRATION26/09/2018 - 25/09/2023

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1FINGERTIP PULSE OXIMETERAT101
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