DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | SURIA-MEDIK SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC10153821-73656 |
| BRAND NAME | CHARMCARE |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | The SpO2 function is indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients. The device is reusable. Accessories connected to the device will be contacted to the patient's finger. Pulse oximeter is equipped with validated software for operation. Accessories include SpO2 finger probe which is either reusable or disposable. |
| DEVICE INTENDED PURPOSE | The intended use of CX130 is detecting and measurement as below parameters to provide and help doctors for making figure out the patient’s vital condition. • Exact and stable Oxygen saturation of arterial blood • Accurate Pulse Rate Especially, CX130 has AGC (Auto Gain Controller) function for weak pulsatile patients. The device is to detect and control its gain automatically in accordance with patient’s pulse rate strength. Designed for hospital, transport and home use. |
| VALIDITY DATE OF REGISTRATION | 14/09/2021 - 13/09/2026 |