DEVICE DETAILS
NAME OF DEVICE | YIMI PULSE OXIMETER |
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ESTABLISHMENT NAME | BIONICS SCIENCES SDN. BHD. |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC5113721-74424 |
BRAND NAME | YIMI |
MEDICAL DEVICE CATEGORY | MD 0104 - Non-active medical devices with measuring function |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Pulse Oximeters are the electronic medical device used to measure the oxygen level (oxygen saturation, SpO2 %) in the hemoglobin of the blood as hemoglobin in the blood act as the carrier of the oxygen molecules. This Pulse Oximeter is also used to check how well can the heart pumping the oxygen throughout the whole body and Heart Pulse Rate will be measured in the unit SI of beats per minute (BPM). This Pulse Oximeter is a small, lightweight, and non-invasive electronic medical device which can attach painlessly with the fingertip. It uses light beams to estimate the oxygen saturation of the blood and the pulse rate. |
DEVICE INTENDED PURPOSE | The model YM101/YM102/YM103/YM201 is intended for measure the oxygen saturation and heart pulse rate for adults patient. |
VALIDITY DATE OF REGISTRATION | 30/09/2021 - 29/09/2026 |