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DEVICE DETAILS

NAME OF DEVICECHILINE PULSE OXIMETER MONITORING SYSTEM (WITH OR WITHOUT MONITORING RESPIRATION)
ESTABLISHMENT NAMEWELLSPRING SOLUTIONS SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC6331224-177056
BRAND NAMECHILINE/ S68 AND S68 LITE
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThis product is a monitoring system for blood oxygen level and respiration. It can simultaneously measure blood oxygen level (SpO2), heart rate and respiratory rate, and can record and display results.
DEVICE INTENDED PURPOSEThis product uses optical sensor, a non-invasive technology that is suitable for adults, children and infants. Upon recommendations from their physicians, users can operate this product on their own to measure single or continuous blood oxygen level, heart rate and respiratory rate. The results will be displayed in a mobile App, serving as a reference for physicians for diagnosis. Note: Model S68 Lite does not have a respiratory monitoring feature.
VALIDITY DATE OF REGISTRATION20/07/2024 - 19/07/2029

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