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/2022/000205_0cd899f520408fad46ffc84616a299e6_881046f40533787346edadfa23838b19. This device is marketed under the brand name Accu-chek Guide Link meter. The license holder is Roche Diabetes Care India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Blood Glucose Meter

UID: IMP/IVD/2022/000205_0cd899f520408fad46ffc84616a299e6_881046f40533787346edadfa23838b19

Brand Name

Accu-chek Guide Link meter

License Holder

Roche Diabetes Care India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

Accu-Chek Guide strips with Accu-Chek GuideLink meter are intended to quantitatively measure glucose in fresh Capillary whole blood from the finger, palm, forearm and upper arm as an aid in monitoring the effectiveness of glucose control. Accu-Chek Guide strips with Accu-Chek GuideLink meter are intended for in vitro diagnostic self-testing by people with diabetes. Accu-Chek Guide strips with Accu-Chek GuideLink meter are intended for in vitro diagnostic used by health care professional in clinical settings. Venous, arterial and neonatal blood testing is limited to healthcare professional use. This system is not for use diagnosis of diabetes mellitus, not for testing neonate cord blood samples. The Accu-Chek GuideLink Blood Glucose Monitoring System is intended to be used to wirelessly transmit glucose values to a Compatible BLE pump through the use if Bluetooth low energy communication Suitable for self-testing