# Dexcom, Inc. (manufacturer, Mesa, AZ): 3 new FDA device listings, incl. integrated continuous glucose monitor for non-intensive glucose manage

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Dexcom, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Mesa, AZ, US |
| New listings | 3 |
| 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 |
| Product codes | SBH, KGX, SAF |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, General Hospital |
| Brand names | Stelo |
| First new listing | 2026-07-17 |
| Latest new listing | 2026-08-10 |
| FDA registration number | 3017425868 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

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.