# Dexcom International Limited (foreign exporter, Athenry Galway(County), IE): 5 new FDA device listings, incl. integrated continuous glucose monitor for non-intensive glucose manage

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Dexcom International Limited |
| Owner / operator | Dexcom, Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Athenry Galway(County), IE |
| New listings | 5 |
| Devices | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Product codes | SBH, KGX, SAF, QBJ |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, General Hospital |
| Brand names | Stelo; Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System |
| First new listing | 2026-07-17 |
| Latest new listing | 2026-08-10 |
| FDA registration number | 3037326582 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.