Roffe international BUZUD Continuous Glucose Monitoring System
- Registration number
- DE0510044
- Model name
- Continuous Glucose monitoring system sensor; Continuous Glucose Monitoring App iOS; Continuous Glucose Monitoring App iOS; Continuous Glucose Monitoring App Android; Continuous Glucose Monitoring App Android
- Model identifier
- GX-01S; RC2107; RC2108; RC2109; RC2110
- Registration date
- November 14, 2024
- Source update date
- April 14, 2025
- Risk class
- Class C
- Product owner
- Roffe International Holdings Pte Ltd
- Registrant / registration holder
- ROFFE INTERNATIONAL HOLDINGS PTE. LTD.
The Continuous Glucose Monitoring System sensor is a real time, continuous glucose monitoring device. When the system is used together with compatible devices, it is indicated for the management of diabetes in people (age 2 and older). It is designed to replace finger stick blood glucose testing for diabetes treatment decisions. Interpretation of the system results should be based on the glucose trends and several sequential readings over time. The system also detects trends and tracks patterns, and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long- term therapy adjustment.
- Product owner address
- 585 NORTH BRIDGE ROAD, #01-02, RAFFLES HOSPITAL, Singapore 188770
- Registrant address
- 585 NORTH BRIDGE ROAD, #01-02, RAFFLES HOSPITAL, Singapore 188770
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.