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 DEVICEPULSE OXIMETER
ESTABLISHMENT NAMEBION MEDICAL SDN BHD
REGISTRATION NOGB3492221-65288
BRAND NAMEBION
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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