Flash Glucose Monitoring System
- UID
- IMP/MD/2020/000594_ee2ebfff130de3eda47b253203a775dc_2ee4b4649d5e6459ea89e26fa559f0c4
- Device class
- Class C
- Brand name
- FreeStyle Libre Pro
- License holder
- Abbott Healthcare Private Limited
- 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.
Flash Glucose Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000594_ee2ebfff130de3eda47b253203a775dc_2ee4b4649d5e6459ea89e26fa559f0c4. 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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