Singapore HSA registration DE0507534
Dexcom Dexcom G6 Continuous Glucose Monitoring System
Singapore·CLASS C·DEXCOM, INC·Registered November 24, 2022Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507534
- Registration Date
- November 24, 2022
- Change Notification Approval Date
- May 07, 2025
- Retention Due Date
- November 23, 2025
Product description
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System or G6) is a glucose monitoring system indicated for persons age 2 years and older, including pregnant women. The Dexcom G6 System is designed to replace fingerstick blood glucose (BG) testing for treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 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, CA 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)
- G6 Receiver G6 Receiver (Replacement) G6 Sensor/Applicator G6 Sensor/Applicator G6 Transmitter G6 CGM App G6 CGM App
- Model Identifier(s)
- STK-GS-109 STR-GS-102 STS-GS-002 STS-GS-003 STT-GS-003 SW11586 SW11588
About this record
Access comprehensive regulatory information for Dexcom Dexcom G6 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 DE0507534 and owned by DEXCOM, INC. The device was registered on November 24, 2022.
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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