DEVICE DETAILS
| NAME OF DEVICE | FINGERTIP OXIMETER |
|---|---|
| ESTABLISHMENT NAME | EYESMILE CREATIONS SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB10977823-150408 |
| BRAND NAME | CREATIVE MEDICAL |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The pulse oxygen saturation (SpO2) is the percentage of oxyhemoglobin (HbO2) in the total hemoglobin (Hb) in the blood, so-called the O2 concentration in the blood. It is an important biological parameter for the respiration. Many of the respiratory disease will cause hypoxemia, even damage the patient’s life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional method to measure SpO2 was to take a blood sample from the patient, and then analyzed it by a blood gas analyzer for Partial Pressure of Oxygen, by which SpO2 would be calculated. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter which can measure the pulse rate simultaneously. The Fingertip Oximeter is small in size, low power consumption, convenient to use and easy to carry. You just need to put a finger into the sensor of the device, the SpO2 value will appear in the screen immediately |
| DEVICE INTENDED PURPOSE | This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient’s finger. It is applicable for spot-checking SpO2 and pulse rate of adult and pediatric patients in homes and clinics |
| VALIDITY DATE OF REGISTRATION | 05/10/2023 - 04/10/2028 |