Color Card - India CDSCO Medical Device Registration

Color Card is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000178_0709d50e78e646293ee6e3da507eea43_f3187ffeaaf43ad484946c84d88b6a56. This device is marketed under the brand name Accu-Chek SugarView Color Card. 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

Color Card

UID: IMP/IVD/2023/000178_0709d50e78e646293ee6e3da507eea43_f3187ffeaaf43ad484946c84d88b6a56

Brand Name

Accu-Chek SugarView Color Card

License Holder

Roche Diabetes Care India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Accu-Chek SugarView Color Card are intended to be used together with the Accu-Chek SugarView app 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 (Accu-Chek SugarView Color Card) 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.