Glucometer
- UID
- IMP/IVD/2021/000021_3393a7b3abb61ba1a9e8865564d1b8b3_c35bf589c9e5b46a5d12031f483ac510
- Device class
- Class C
- Brand name
- FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified
- License holder
- Abbott Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- The FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System is for use outside the body only (FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified) for self -testing or professional use as an aid in the management of diabetes. Use for measuring glucose in fresh whole blood samples taken from fingers, forearm, upper arm or the base of the thumb. Use for measuring ketone (FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified) in fresh whole blood samples from fingers only. The system may also aid in the management of diabetes by providing the user with suggested recommendations to insulin dose(FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified) based on healthcare professional entered data
Glucometer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000021_3393a7b3abb61ba1a9e8865564d1b8b3_c35bf589c9e5b46a5d12031f483ac510. This device is marketed under the brand name FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified. 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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