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Blood Glucose Test Strips - India CDSCO Medical Device Registration

Blood Glucose Test Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000264_3901a1a3f8ab8fc6f484269513c6a012_eeecec87b13ec58ee9e3ca0e98ddb593. This device is marketed under the brand name Accu-Chek guide. 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 Test Strips
UID: IMP/IVD/2019/000264_3901a1a3f8ab8fc6f484269513c6a012_eeecec87b13ec58ee9e3ca0e98ddb593

Brand Name

Accu-Chek guide

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Accu-Chek Guide test strips with the Accu-Chek Guide meter are intended to quantitatively measure glucose in fresh capillary whole blood from finger, palm, forearm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide test strip with Accu-Chek Guide meter are intended for in-vitro diagnostic self-testing by people with diabetes. The Accu-Chek Guide test strip with Accu-Chek Guide meter are intended for in vitro diagnostic use by healthcare professionals in clinical settings. venous, arterial, and neonatal blood testing is limited to healthcare professional use. This system is not for use in diagnosis of diabetes mellitus, nor for testing neonate cord blood samples.

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