LibreView software which includes LibreLinkUp mobile application - India CDSCO Medical Device Registration

LibreView software which includes LibreLinkUp mobile application is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000740_dcac0b959cf70ea69a37eb18ee71e2f1_a566f7a7eead21c2c6726ba280800f77. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

LibreView software which includes LibreLinkUp mobile application

UID: IMP/MD/2023/000740_dcac0b959cf70ea69a37eb18ee71e2f1_a566f7a7eead21c2c6726ba280800f77

License Holder

Abbott Healthcare Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

LibreView is intended for use by patients, caregivers and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose device data to support effective diabetes management. In addition: LibreView is a secondary viewer and is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice. LibreView is not intended to be used for immediate clinical decision making, and is not intended to replace self-monitoring practices as advised by a physician. Home users should consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Healthcare professionals should use information in the software in conjunction with other clinical information available to them