DEVICE DETAILS
| NAME OF DEVICE | BLOOD PRESSURE MONITOR |
|---|---|
| ESTABLISHMENT NAME | PFLEGE MEDICAL SUPPLIES SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB6629421-64630 |
| BRAND NAME | PROFIX |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | PROFIX Blood Pressure Monitor is Fully Automatic type blood pressure monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at Fully Automatic within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. PROFIX Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm (about 8¾˝-12½˝) or 22 cm to 42 cm (about 8¾˝-16½˝). It is intended for adult indoor use only. |
| DEVICE INTENDED PURPOSE | PROFIX Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm (about 8¾˝-12½˝) or 22 cm to 42 cm (about 8¾˝-16½˝). It is intended for adult indoor use only. |
| VALIDITY DATE OF REGISTRATION | 21/06/2021 - 20/06/2026 |