Glucometer - India CDSCO Medical Device Registration

Glucometer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000153_3393a7b3abb61ba1a9e8865564d1b8b3_9de4d51fb4ebfd2109d453eeb578cd26. This device is marketed under the brand name XpressGluco + Blood Glucose Monitoring System. The license holder is Accurex Biomedical Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class C

Glucometer

UID: MFG/IVD/2022/000153_3393a7b3abb61ba1a9e8865564d1b8b3_9de4d51fb4ebfd2109d453eeb578cd26

Brand Name

XpressGluco + Blood Glucose Monitoring System

License Holder

Accurex Biomedical Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The XpressGluco + Blood Glucose Monitoring System is intended for use outside the body (XpressGluco + Blood Glucose Monitoring System). It should be used only for self-testing blood glucose (XpressGluco + Blood Glucose Monitoring System) and only with fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system is intended for use in the home and in clinical settings. The system should not be used for the diagnosis of diabetes or for the testing of newborns.