DEVICE DETAILS
| NAME OF DEVICE | NOVOPLUS BLOOD PRESSURE MONITOR |
|---|---|
| ESTABLISHMENT NAME | REVO HEALTHCARE SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB6355719-26800 |
| BRAND NAME | NOVOPLUS |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Blood Pressure Monitor is a device designed to measure blood pressure and pulse rate using noninvasive technique in which an inflatable cuff is wrapped around the user’s upper arm. The technique to define the blood pressure (systolic and diastolic pressures) is similar to the auscultatory method but utilize an electronic capacitive pressure sensor rather than the mercury manometer and stethoscope. This sensor converts the tiny alteration in the cuff pressure to electrical signals; these signals are analyzed to define the systolic and diastolic pressures and calculating pulse rate which is a well-known technique called the oscillometric method. |
| DEVICE INTENDED PURPOSE | The Blood Pressure Monitor is intended to measure the systolic pressure, diastolic pressure through upper arm. It’s expected to be used at home or in the hospital, intended for people over 12 years old. |
| VALIDITY DATE OF REGISTRATION | 13/03/2019 - 12/03/2024 |