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.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER
ESTABLISHMENT NAMERESETT SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB7610823-132933
BRAND NAMEACCURATE
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe pulse oximeter can monitor significant vital sign parameters of patients, including SpO2 and Pulse. It senses arterial oxygen saturation physiological change with sensor and converses it to electric signal. Then, the data are calculated and analyzed by data analysis software and displayed on LCD.
DEVICE INTENDED PURPOSEThe Pulse Oximeter is a portable, convenient, non-invasive device, used for monitor arterial hemoglobin oxygen saturation (SpO2) and pulse rate. The personal application are adult patients (weight: >30kgs) and pediatric patients (weight: 20-30kgs). We recommend index finger, middle finger and ring finger are suitable position for monitor. It's intended for spot-checking or attended-care monitoring in Home Health Care and Medical Facility.
VALIDITY DATE OF REGISTRATION26/05/2023 - 25/05/2028

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1PULSE OXIMETER6927394500210
Back