Singapore HSA registration DE0510107
Changsha Sinocare Sinocare iCan i3 Continuous Glucose Monitoring System
Singapore·CLASS C·Changsha Sinocare Inc.·Registered December 04, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510107
- Registration Date
- December 04, 2024
- Retention Due Date
- December 03, 2025
Product description
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
- Short Name
- Changsha Sinocare Inc.
- Address
- No.265, Guyuan Road, Hi-tech Zone,, Changsha, Hunan Province 410205, CHINA
Registrant
- Address
- 300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Model information
- Model Name(s)
- Continuous Glucose Monitoring System iCan Health APP iCan Health APP
- Model Identifier(s)
- i3 iCan Health APP (Andriod) iCan Health APP (iOS)
About this record
Access comprehensive regulatory information for Changsha Sinocare Sinocare iCan i3 Continuous Glucose Monitoring System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510107 and owned by Changsha Sinocare Inc.. The device was registered on December 04, 2024.
This page provides complete registration details including product owner information, registrant details, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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