Blood Glucose Monitoring System - India CDSCO Medical Device Registration

Blood Glucose Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000101_0054b22abb292e0ea5155b56e0c4e672_0d6ba30d686e0c938976d51f4d84c773. This device is marketed under the brand name DIAVUE Prudential. The license holder is Arkray Healthcare Pvt., Ltd, 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 Monitoring System

UID: IMP/IVD/2022/000101_0054b22abb292e0ea5155b56e0c4e672_0d6ba30d686e0c938976d51f4d84c773

Brand Name

DIAVUE Prudential

License Holder

Arkray Healthcare Pvt., Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The system is intended for use outside the body (DIAVUE Prudential) by people with diabetes at home and by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (DIAVUE Prudential)in venous and capillary whole blood samples (DIAVUE Prudential).