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CDSCO UID IMP/IVD/2021/000387_54c4a592576331b2ab3e6e4663d39274_515f126a0465035376d5fd183b0f3757

Blood glucose meter

ISENS BIOSENSORS INDIA PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: COOL
Registration details
UID
IMP/IVD/2021/000387_54c4a592576331b2ab3e6e4663d39274_515f126a0465035376d5fd183b0f3757
Device class
Class C
Brand name
COOL
License holder
ISENS BIOSENSORS INDIA PRIVATE LIMITED
Approving authority
CDSCO
Product information
COOL Blood Glucose Monitoring System is used for the quantitative measurement of the glucose level in capillary whole blood as an aid in monitoring diabetes management effectively at home or in clinical settings. COOL Blood Glucose Monitoring System should be used only for self-testing outside the body (COOL). COOL Blood Glucose Monitoring System should not be used for the diagnosis of diabetes. Testing sites include the traditional fingertip testing along with alternate site testing on forearm, palm.
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About this record

Blood glucose meter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000387_54c4a592576331b2ab3e6e4663d39274_515f126a0465035376d5fd183b0f3757. This device is marketed under the brand name COOL. The license holder is ISENS BIOSENSORS INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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