Flash Glucose Monitoring System- Sensor
- UID
- IMP/MD/2022/000591_9e0864c7218e6e58008d44c47c9110a2_dfc951a33873afd90cd9252a8fe053ba
- Device class
- Class C
- Brand name
- FreeStyle Libre
- License holder
- Abbott Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- The FreeStyle Libre Flash Glucose Monitoring System Sensor (FreeStyle Libre) when used with a compatible device is indicated for measuring interstitial fluid glucose levels in people(FreeStyle Libre) with diabetes mellitus, including pregnant women. The Sensor and compatible device are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. The indication for children (FreeStyle Libre) 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 sensor and compatible device and also for interpreting or assisting the child to interpret Sensor glucose readings.
Flash Glucose Monitoring System- Sensor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000591_9e0864c7218e6e58008d44c47c9110a2_dfc951a33873afd90cd9252a8fe053ba. This device is marketed under the brand name FreeStyle Libre. 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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