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Blood Glucose Monitoring Strips - India CDSCO Medical Device Registration

Blood Glucose Monitoring Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000016_51853e25fbc3b973cf42451728f09b17_a94083368cf41f0858abf7041626c507. This device is marketed under the brand name Accu-chek Aviva test strips. The license holder is M/s.Roche Diabetes Care India Private Limited, and it is classified as Device Class Class B. 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.

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CDSCO Registered
Class Class B
Blood Glucose Monitoring Strips
UID: IMP/IVD/2020/000016_51853e25fbc3b973cf42451728f09b17_a94083368cf41f0858abf7041626c507

Brand Name

Accu-chek Aviva test strips

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Accuโ€‘Chek Performa test strips are intended to be used with the Accuโ€‘Chek Performa, Accuโ€‘Chek Performa Nano and Accuโ€‘Chek Performa Solo blood glucose meters to quantitatively measure glucose in fresh capillary whole blood as an aid in monitoring the effectiveness of controlling glucose. Testing sites for the Accuโ€‘Chek Performa and Accuโ€‘Chek Performa Nano meters include the finger, palm, forearm and upper arm. The testing site for the Accu-Chek Performa Solo meters is the fingertip. The Accuโ€‘Chek Performa test strips, used with the Accuโ€‘Chek Performa and Accuโ€‘Chek Performa Nano meters are intended for in vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home. The Accu-Chek Performa Solo meters are for home use only. Healthcare professionals can use venous, arterial and neonatal blood with the Accu-Chek Performa and Accu-Chek Performa Nano meters. The systems are not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. Venous, arterial and neonatal blood testing is limited to healthcare professional use only.

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