Flash Glucose Monitoring System - India CDSCO Medical Device Registration

Flash Glucose Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000595_ee2ebfff130de3eda47b253203a775dc_60562e89fad9c6789565dde2ea83fa2f. This device is marketed under the brand name FreeStyle Libre Pro. 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

Flash Glucose Monitoring System

UID: IMP/MD/2023/000595_ee2ebfff130de3eda47b253203a775dc_60562e89fad9c6789565dde2ea83fa2f

Brand Name

FreeStyle Libre Pro

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FreeStyle Libre Flash Glucose Monitoring System Reader (FreeStyle Libre Pro) when used with a FreeStyle Libre System Sensor (FreeStyle Libre Pro) is indicated for measuring interstitial fluid glucose levels in people (FreeStyle Libre Pro) with diabetes mellitus, including pregnant women. The Reader and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. The indication for children (FreeStyle Libre Pro) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the Reader and Sensor and also for interpreting or assisting the child to interpret Sensor glucose readings.