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HSA · registration DE0510044

Roffe international BUZUD Continuous Glucose Monitoring System

SingaporeGeneral HospitalClass CRoffe International Holdings Pte Ltd
Official record identity
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
Classification
Risk class
Class C
Official value: CLASS C
Published category
General Hospital
Published parties
Registrant / registration holder
ROFFE INTERNATIONAL HOLDINGS PTE. LTD.
Official description

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.

Additional source fields
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
About this record

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.