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/2021/000419_0054b22abb292e0ea5155b56e0c4e672_ea86961c57aa97a137fa992b54df29b0. This device is marketed under the brand name Accu-Chek Guide Link. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Accu-Chek Guide Link
License Holder
India Medtronic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The Accu‑Chek Guide test strips with the Accu‑Chek Guide Link 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. The Accu‑Chek Guide test strips with the Accu‑Chek Guide Link meter are intended for in vitro diagnostic self-testing by people with diabetes. The Accu‑Chek Guide test strips with the Accu‑Chek Guide Link meter are intended for in vitro diagnostic use by healthcare professionals in clinical settings. Venous, arterial, and neonatal blood testing are limited to healthcare professional use. This system is not for use in diagnosis of diabetes mellitus and not for testing neonate cord blood samples. The Accu‑Chek Guide Link Blood Glucose Monitoring System is intended to be used to wirelessly transmit glucose values to a compatible pump with Bluetooth® wireless technology through the use of Bluetooth low energy communication. Suitable for self-testing.
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