DEVICE DETAILS
| NAME OF DEVICE | ONE TOUCH SELECTSIMPLE BLOOD GLUCOSE MONITORING SYSTEM |
|---|---|
| ESTABLISHMENT NAME | DKSH MALAYSIA SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | IVDC7890023417 |
| BRAND NAME | ONE TOUCH |
| MEDICAL DEVICE CATEGORY | SELF TESTING |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | THE ONETOUCH SELECTSIMPLE™ BLOOD GLUCOSE MONITORING SYSTEM CONSISTS OF: - ONETOUCH SELECTSIMPLE™ METER - ONETOUCH SELECT™ TEST STRIPS - ONETOUCH SELECT™ CONTROL SOLUTION - ONETOUCH® LANCING DEVICE - ONETOUCH ULTRASOFT™ LANCET |
| DEVICE INTENDED PURPOSE | THE ONETOUCH SELECTSIMPLE™ BLOOD GLUCOSE MONITORING SYSTEM IS INTENDED TO BE USED FOR QUANTITATIVE MEASUREMENT OF GLUCOSE IN FRESH CAPILLARY WHOLE BLOOD. THE ONETOUCH SELECTSIMPLE™ SYSTEM IS INTENDED FOR USE OUTSIDE THE BODY (IN VITRO DIAGNOSTIC USE) BY PEOPLE WITH DIABETES AT HOME AND/OR BY HEALTHCARE PROFESSIONALS IN A CLINICAL SETTING AS AN AID TO MONITOR THE EFFECTIVENESS OF DIABETES CONTROL. IT SHOULD NOT BE USED FOR THE DIAGNOSIS OF DIABETES OR TESTING OF NEWBORNS. THE ONETOUCH SELECTSIMPLE™ BLOOD GLUCOSE MONITORING SYSTEM IS SPECIFICALLY INDICATED FOR USE ON THE FINGER, FOREARM OR PALM. |
| VALIDITY DATE OF REGISTRATION | 26/04/2022 - 25/04/2027 |