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_548e9494413a9dfc254ee77bf08c48cc. 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_548e9494413a9dfc254ee77bf08c48cc

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 H Blood Glucose and Ketone Monitoring System is for professional use to measure glucose and ketone (FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified) in fresh whole blood outside the body (FreeStyle Optium Neo blood glucose & Ketone monitoring system 3. Notified).Update in the Intended Use verbiage and included the list of package contents and the necessary materials ,which was not provided in the kit earlier is acknowledged as per new IVDR.