Singapore HSA registration DE0510660
Dexcom Dexcom G7 Continuous Glucose Monitoring System
Singapore·CLASS C·Dexcom, Inc.·Registered May 02, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0510660
- Registration Date
- May 02, 2025
- Retention Due Date
- May 01, 2026
Product description
The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system indicated for continuously measuring glucose in the interstitial fluid in persons age 2 years and older, including pregnant women. The Dexcom G7 CGM System is designed to replace fingerstick blood glucose (BG) testing for treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is intended for use by patients at home and in healthcare facilities.
Product Owner
- Name
- Dexcom, Inc.
- Short Name
- Dexcom, Inc.
- Address
- 6340 Sequence Drive, San Diego, California, 92121, UNITED STATES
Registrant
- Address
- 1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
- Address
- 47 JALAN BUROH, #09-01, SINGAPORE 619491
Model information
- Model Name(s)
- G7 Receiver Subsystem (RVS) G7 Glucose Sensing Subsystem (GSS) G7 Mobile Applications Subsystem (MAS), Android G7 Mobile Applications Subsystem (MAS), iOS G7 Optional Watch Application Subsystem (WAS)
- Model Identifier(s)
- STK-GT-100 STP-GT-006 SW12299 SW12300 SW13355
About this record
Access comprehensive regulatory information for Dexcom Dexcom G7 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 DE0510660 and owned by Dexcom, Inc.. The device was registered on May 02, 2025.
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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