FDA device listing
Stelo
FDA device listing 1893546610 · DEXCOM, INC.
Key facts
| Proprietary names | Stelo |
|---|---|
| Owner/operator | DEXCOM, INC. |
| Owner/operator number | 9071756 |
| Premarket submissions | K261359 |
| Product codes | KGX, SAF |
| Device names | KGX - Tape And Bandage, Adhesive, SAF - Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1355, 880.5240 |
| Review panels | Clinical Chemistry, General Hospital |
| Registered establishments | Dexcom, Inc., DEXCOM, INC., DEXCOM INTERNATIONAL LIMITED, Dexcom (Malaysia) Sdn. Bhd. |
| Establishment registrations | 3004753838, 3013435121, 3017425868, 3027503105, 3037326582 |
| FEI numbers | 3004753838, 3013435121, 3017425868, 3027503105, 3037326582 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database