Continuous Glucose Monitoring System Sensor - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Continuous Glucose Monitoring System Sensor

UID: IMP/MD/2021/000450_15864c9c4b4974ef253b6bbfae68e078_ca807892d8ae14c2047a7da508342df4

Brand Name

FreeStyle Libre Pro iQ

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

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.