Continuous Glucose Monitoring System(FreeStyle Libre Pro iQ ) - India CDSCO Medical Device Registration

Continuous Glucose Monitoring System(FreeStyle Libre Pro iQ ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000503_336b57dcd77d2690d5ead3964ee971b7_b22a6f66f19312da6d86fbeff09f995a. This device is marketed under the brand name Reader. 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(FreeStyle Libre Pro iQ )

UID: IMP/MD/2021/000503_336b57dcd77d2690d5ead3964ee971b7_b22a6f66f19312da6d86fbeff09f995a

Brand Name

Reader

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.