Blood Glucose Meter - India CDSCO Medical Device Registration

Blood Glucose Meter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000226_0cd899f520408fad46ffc84616a299e6_f3b6d243b46cf99a36d7dea99c885987. This device is marketed under the brand name Accu-Chek Active Meter. The license holder is M/s.Roche Diabetes Care India 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

Blood Glucose Meter

UID: IMP/IVD/2022/000226_0cd899f520408fad46ffc84616a299e6_f3b6d243b46cf99a36d7dea99c885987

Brand Name

Accu-Chek Active Meter

License Holder

M/s.Roche Diabetes Care India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Accu-Chek Active blood glucose meter is intended to be used for quantitative blood glucose tests in fresh capillary blood. The meter may only be used together with Accu-Chek Active test strips. Consult the package insert of the test strips if you intend to use different sample material. The blood glucose monitoring system comprises the meter and test strips and is suitable for self-testing and for professional use. People with diabetes can use this system to self-test their blood glucose. Healthcare professionals can use this system to check Patient’s blood glucose values and they can use it in suspected cases of diabetes and in emergency diagnostics. The system is suitable for testing blood glucose with blood obtained from alternative sites. The system must not be used to diagnose or rule out diabetes. The system is only suitable for use outside the body. Visually impaired persons must not use the meter. The system does not require a code chip. The meter must only be used for its intended purpose; if used otherwise preventive measures could be ineffective.