Blood Glucose Monitoring Test Strips, Color Card and Application - India CDSCO Medical Device Registration

Blood Glucose Monitoring Test Strips, Color Card and Application is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000156_55b2b3a8a3173a2c6466989dd745af8a_353e54dc489fe47c9ceda7bdf4759ac8. This device is marketed under the brand name App. The license holder is Roche Diabetes Care India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Blood Glucose Monitoring Test Strips, Color Card and Application

UID: IMP/IVD/2022/000156_55b2b3a8a3173a2c6466989dd745af8a_353e54dc489fe47c9ceda7bdf4759ac8

Brand Name

App

License Holder

Roche Diabetes Care India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Accu-Chek SugarView app together with the Accu-Chek SugarView Color Card are intended to be used as a digital visual check of the color change on the Accu-Chek Active test strip once a capillary blood sample has been applied onto the test field. The app interprets the color change on the test strip using the standard color information provided by the accessory Accu-Chek SugarView Color Card. A blood glucose result is displayed on the smartphone display, expressed in form of a semi quantitative blood glucose range. The results are saved into the app and can be used as an electronic blood glucose result diary. The Accu-Chek SugarView app used together with the Accu-Chek SugarView Color Card is intended to provide semi-quantitative information on the blood glucose concentration and how it is influenced by food intake, physical activity, illness and other factors. The app is primarily intended to be used by the user himself, but a third party (App) may also employ it.