DEVICE DETAILS
| NAME OF DEVICE | BUZUD PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | BUZUD MALAYSIA SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB6901926-239654 |
| BRAND NAME | BUZUD |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | SpO2 stands for peripheral capillary oxygen saturation. Oxygen saturation is defined as the ratio of oxyhemoglobin (HbO2) to the total concentration of hemoglobin (i.e. Oxyhemoglobin + reduced hemoglobin) present in the blood. It is an important physiological parameter involved in respiration and circulation. The Pulse Oximeter feature herein is small, portable, non-invasive and easy to use. The user only needs to insert a finger into the chamber to measure his/her SpO2 and pulse rate. The oximeter is suitable for home healthcare environments. |
| DEVICE INTENDED PURPOSE | The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients. |
| VALIDITY DATE OF REGISTRATION | 10/08/2026 - 09/08/2031 |