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 DEVICEPULSE OXIMETER (PO2)
ESTABLISHMENT NAMESIXMURS MALAYSIA SDN. BHD.
REGISTRATION NOGB8384624-166521
BRAND NAMELEPU MEDICAL
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe pulse oxygen saturation, the percentage of HbO2 in the total Hb in the blood, namely the so-called O2 concentration in the blood, is an important bio-parameter for the respiration. The intergradations of oxygen molecule in the blood and hemoglobin in erythrocyte are reversible. Hemoglobins integrated with oxygen are called HbO2, and those released O2 are called HbR. Oxyhemoglobin and deoxyhemoglobin (HHb) absorb red Marginal and infrared of specific wavelength, thus the Marginal of the two wavelengths emitted from SpO2 sensor is absorbed when it passes through the finger, and approximate pulse oxygen saturation is calculated by measuring absorption of the Marginal.
DEVICE INTENDED PURPOSEThis Pulse Oximeter is intended to be used for measuring, displaying and storing of pulse oxygen saturation (SpO2), pulse rate of adults in home or healthcare facilities environment.
VALIDITY DATE OF REGISTRATION13/03/2024 - 12/03/2029

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1PULSE OXIMETER (PO2)PO2