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 MFG/IVD/2023/000094_0054b22abb292e0ea5155b56e0c4e672_055b993fc26d8d683e622290124b4d45. This device is marketed under the brand name Dr.Trust, Ambitech Elizy, Fitazo,Glucometer Machine, Glucometer and Gluco Sem.. The license holder is Sensa Core Medical Instrumentation Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.
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Brand Name
Dr.Trust, Ambitech Elizy, Fitazo,Glucometer Machine, Glucometer and Gluco Sem.
License Holder
Sensa Core Medical Instrumentation Pvt. Ltd.Device Class
Approving Authority
CDSCO, Zonal office, Hyderabad
Product Information
The Blood Glucose Monitoring System intended for in vitro diagnostic use by lay person(Dr.Trust, Ambitech Elizy, Fitazo,Glucometer Machine, Glucometer and Gluco Sem.) and for point of care usage for the quantitative determination of Glucose in fresh capillary whole blood as an aid to evaluate the patients suspected of having diabetes. The Blood Glucose Monitoring System may only be used together with Blood Glucose Test Strip.
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