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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEGAS WALKER MIRAMED SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC9480821-57718
BRAND NAMEYUWELL
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONPulse oximeter is a noninvasive method for monitoring a person's oxygen saturation (SO2). Though its reading of SpO2 (peripheral oxygen saturation) is not always identical to the more desirable reading of SaO2 (arterial oxygen saturation) from arterial blood gas analysis, the two are correlated well enough that the safe, convenient, noninvasive, inexpensive pulse oximetry method is valuable for measuring oxygen saturation in clinical use.
DEVICE INTENDED PURPOSEThe fingertip Oximeter can be used to measure human Haemoglobin Saturation and heart rate through finger, the product is suitable for family, hospital (including clinical use in internist/surgery, Anaesthesia, paediatrics, intensive sports (It can be used before or after sport. Operation in sport is not recommended) and etc.The product is not suitable to monitor patient continuously.
VALIDITY DATE OF REGISTRATION24/03/2021 - 23/03/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Fingertip Pulse OximeterYX302
2Fingertip Pulse OximeterYX100
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