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 NAMEQUANTUM UPSTREAM SDN.BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC5277326-222891
BRAND NAMEEZYSWISS
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONezyswissTM Fingertip Pulse Oximeter main function of the Pulse Oximeter is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking monitoring. The subject device determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring theabsorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a standalone device with 1 AAA Alkaline battery. It includes an LED, OLED display screen and a warning or indicator function for abnormal readings.
DEVICE INTENDED PURPOSEMeasurement of functional arterial oxygen saturation (SpO˜) and pulse rate.
VALIDITY DATE OF REGISTRATION16/01/2026 - 15/01/2031

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