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 NAMEK-ONE MEDITECH SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC8924622-95826
BRAND NAMEMEDKAIRE
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONFingertip Pulse Oximeter for single use, Brand name: "Medkaire" and model is PC060B1. The intended use and indication in its label as show instruction for use of the Fingertip Pulse Oximeter. Mark with CE with certification and the label-used language must be in accordance with the EC requirements.
DEVICE INTENDED PURPOSEThis Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through a patient’s finger. It is applicable for spot-checking SpO2 and pulse rate of adult and pediatric patients in homes and medical clinics. The Fingertip Oximeter is small in size, low power consumption, convenient to use and easy to carry. You just need to put a finger into the sensor of the device, the SpO2 value will appear in the screen immediately.
VALIDITY DATE OF REGISTRATION20/06/2022 - 19/06/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1FINGERTIP PULSE OXIMETER PC060B1
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