HSA · registration DE0510660Dexcom Dexcom G7 Continuous Glucose Monitoring System
- Registration number
- DE0510660
- Model name
- 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
- STK-GT-100; STP-GT-006; SW12299; SW12300; SW13355
- Registration date
- May 02, 2025
- Source update date
- April 29, 2026
- Risk class
- Class C
- Product owner
- Dexcom, Inc.
- Registrant / registration holder
- EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
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 address
- 6340 Sequence Drive, San Diego, California, 92121, United States
- Registrant address
- 1 HARBOURFRONT PLACE, #11-01-03, HARBOURFRONT TOWER ONE, Singapore 098633
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.