Continuous Glucose Monitoring System Sensor
- UID
- IMP/MD/2021/000450_15864c9c4b4974ef253b6bbfae68e078_ca807892d8ae14c2047a7da508342df4
- Device class
- Class C
- Brand name
- FreeStyle Libre Pro iQ
- License holder
- Abbott Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- The FreeStyle Libre Pro iQ Continuous Glucose Monitoring System is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis and interpretation of glycaemic variability in persons aged 4 and older under the supervision of a healthcare professional. The System collects and processes data for aiding in the management of a disease or condition related to glycaemic control. Interpretation of the data recorded by the system should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The System aids in detecting glucose excursions facilitating care plan adjustments. The System is also intended to interface with digitally connected devices. The System has been evaluated for use in pregnant women.
Continuous Glucose Monitoring System Sensor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000450_15864c9c4b4974ef253b6bbfae68e078_ca807892d8ae14c2047a7da508342df4. This device is marketed under the brand name FreeStyle Libre Pro iQ. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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