CDSCO UID IMP/MD/2023/000740_8af81f55ddb3a41cf76ac30652d87cf7_7b548eb8c3cb915940eb60ee9fed916e
FreeStyle LibreLink app
Abbott Healthcare Private Limited·Device Class Class B·India CDSCO
Registration details
- UID
- IMP/MD/2023/000740_8af81f55ddb3a41cf76ac30652d87cf7_7b548eb8c3cb915940eb60ee9fed916e
- Device class
- Class B
- License holder
- Abbott Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- FreeStyle LibreLink app (NA) when used with a FreeStyle Libre or FreeStyle Libre 2 Flash Glucose Monitoring System Sensor (NA) is indicated for measuring interstitial fluid glucose levels in people (NA) with diabetes mellitus, including pregnant women. The App and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. The indication for children (NA) 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 App and Sensor and also for interpreting or assisting the child to interpret Sensor glucose readings. Note: Not all Sensors are available in all countries. WARNING: If you are using FreeStyle LibreLink, you must also have access to a blood glucose monitoring system as the App does not provide one.
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Flash Glucose Monitoring System-Sensor
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About this record
FreeStyle LibreLink app is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000740_8af81f55ddb3a41cf76ac30652d87cf7_7b548eb8c3cb915940eb60ee9fed916e. 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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