Glucometer - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Glucometer

UID: IMP/IVD/2021/000021_3393a7b3abb61ba1a9e8865564d1b8b3_c35bf589c9e5b46a5d12031f483ac510

Brand Name

FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

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