HSA · registration DE0510107Changsha Sinocare Sinocare iCan i3 Continuous Glucose Monitoring System
- Registration number
- DE0510107
- Model name
- Continuous Glucose Monitoring System; iCan Health APP; iCan Health APP
- Model identifier
- i3; iCan Health APP (Andriod); iCan Health APP (iOS)
- Registration date
- December 04, 2024
- Risk class
- Class C
- Product owner
- Changsha Sinocare Inc.
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
The Continuous Glucose Monitoring System is a real time, continuous glucose monitoring device indicated for the management of diabetes for adult people (age 18 and older). The system is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The CGM also detects trends and tracks patterns, and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long- term therapy adjustments. Interpretation of the System results should be based on the glucose trends and several sequential readings over time. The CGM can be used in conjunction with smart devices where the user manually controls actions for therapy decisions.
- Product owner address
- No.265, Guyuan Road, Hi-tech Zone,, Changsha, Hunan Province 410205, China
- Registrant address
- 300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.