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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEREANNEQ SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC2559524-183885
BRAND NAMEOUSON
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Fingertip Pulse Oximeter is a non-invasive device intended for measure oxygen saturation (SpO2) and pulse rate of adults and children. This oximeter is intended for use in home, hospital, clinical institution, healthcare community. The oximeter is NOT design for newborn and infant. The product is suitable for adults or children (Weight should be between 25kg to 110kg). The safety and performance of this device comply with standard IEC/EN 60601-1, ISO 80601-2-61.
DEVICE INTENDED PURPOSEThe Fingertip Pulse Oximeter is a non-invasive device intended for measure oxygen saturation (SpO2) and pulse rate of adults and children. This oximeter is intended for use in home, hospital, clinical institution, healthcare community. The oximeter is NOT design for newborn and infant. The product is suitable for adults or children (Weight should be between 25kg to 110kg). The safety and performance of this device comply with standard IEC/EN 60601-1, ISO 80601-2-61.
VALIDITY DATE OF REGISTRATION17/09/2024 - 16/09/2029

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Fingertip Pulse OximeterBSX 231
2Fingertip Pulse OximeterBSX 233
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