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 DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMETST HEALTH CARE SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC3239621-80138
BRAND NAMESONOSAT F02W
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONFINGERTIP PULSE OXIMETER IS A PORTABLE NON-INVASIVE SPOT-CHECK MEASUREMENT DEVICE APPLICABLE TO CHECK BLOOD OXYGEN SATURATION (SPO2), PULSE MONITORING (BPM), AND BLOOD PERFUSION INDEX (PI) THROUGH A PATIENT'S FINGER. THIS MEDICAL DEVICE CAN BE REUSED. NOT FOR CONTINUING MONITORING.
DEVICE INTENDED PURPOSETO BE USED FOR HOME CARE AND MEDICAL OUTPATIENT DEPARTMENT MEASURE PULSE OXYGEN SATURATION AND PULSE RATE OF ADULTS AND PAEDIATRICS.
VALIDITY DATE OF REGISTRATION01/12/2021 - 30/11/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1FINGERTIP PULSE OXIMETERSONOSAT F02W
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