Singapore HSA registration DE0510044
Roffe international BUZUD Continuous Glucose Monitoring System
Singapore·CLASS C·Roffe International Holdings Pte Ltd·Registered November 14, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510044
- Registration Date
- November 14, 2024
- Change Notification Approval Date
- April 14, 2025
- Retention Due Date
- November 13, 2025
Product 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.
Product Owner
- Short Name
- Roffe International Holdings Pte Ltd
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Registrant
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Importer
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Model information
- Model Name(s)
- 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(s)
- GX-01S RC2107 RC2108 RC2109 RC2110
About this record
Access comprehensive regulatory information for Roffe international BUZUD 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 DE0510044 and owned by Roffe International Holdings Pte Ltd. The device was registered on November 14, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, 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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