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/2021/000034_0054b22abb292e0ea5155b56e0c4e672_790b57782167f57f3a083c3f8a24c5d2. The license holder is Morepen Laboratories Ltd., and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

Blood Glucose Monitoring System

UID: MFG/IVD/2021/000034_0054b22abb292e0ea5155b56e0c4e672_790b57782167f57f3a083c3f8a24c5d2

License Holder

Morepen Laboratories Ltd.

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

This APG-01 Blood Glucose Monitor is intended for the quantitativemeasurement of the concentration of glucose in capillary wholeblood from fi ngertip, palm and forearm by diabetic patients orHealthcare Professionals as an aid in the management of diabetes. Itis intended for use outside of the body ##PLACEHOLDER_0## andnot for diagnosis of or screening for diabetes, nor for use on neonatesor arterial blood. The alternative site testing ##PLACEHOLDER_0## inthis system can only be used during steady-state blood glucoseconditions