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DEVICE DETAILS

NAME OF DEVICEGLUNEO LITE BLOOD GLUCOSE MONITORING SYSTEM
ESTABLISHMENT NAMEREVO HEALTHCARE SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOIVDC2390019-28353
BRAND NAMEGLUNEO LITE/ INFOPIA
MEDICAL DEVICE CATEGORYDevice for self-diagnosis: device for the measurement of blood Sugar
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe IGM-1003A Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. IGM-1003A Blood Glucose Monitoring System is for self-testing outside the body (in-vitro diagnostic use only).
DEVICE INTENDED PURPOSEThe IGM-1003A Blood Glucose Monitoring System is intended for use outside the body only (in-vitro diagnostic use) and self-testing. The test results make it easier for your doctor to access your metabolic control. However, the self-testing should not take the place of overall diabetes management assessment from your doctor. It should be used only for testing blood glucose (sugar), and only with fresh capillary and venous whole blood samples. The IGM -1003A Blood Glucose Monitoring System is intended for use in the home and in professional setting to monitor blood glucose levels.
VALIDITY DATE OF REGISTRATION02/05/2019 - 01/05/2024

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