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_01c5b596ae64883095465e4e1bbd8f98. 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_01c5b596ae64883095465e4e1bbd8f98

Brand Name

FreeStyle Libre Pro

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FreeStyle Libre Pro Flash Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (FreeStyle Libre Pro) with diabetes. 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 system is intended for use by health care professionals. Readings from the FreeStyle Libre Pro Flash Glucose Monitoring System are not made available directly to patients in real time. The FreeStyle Libre Pro Flash Glucose Monitoring System aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating therapy adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should be based on the trends and patterns analysed through time using the reports available