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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER
ESTABLISHMENT NAMEBION MEDICAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB3492221-65288
BRAND NAMEBION
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe pulse oximeter is used to measure arterial oxygen saturation (% SpO2), the percentage of oxyhemoglobin (HbO2) relative to the total hemoglobin (Hb). It also measures the pulse rate (PR, the number of pulse beats per minute), and gives the perfusion index, an indication of pulse strength at the monitoring site.
DEVICE INTENDED PURPOSEThe pulse oximeter uses the non-invasive optical transmittance method to measure arterial oxygen saturation and pulse rate. Do not use it for continuous care for patients.
VALIDITY DATE OF REGISTRATION18/06/2021 - 17/06/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1FingerTip Pulse OximeterP100
2FingerTip Pulse Oximeter with Blue toothP100BT
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