FDA Registration
Active
🇺🇸 United States
DEXCOM, INC.
Reg #: 3004753838
·
FEI: 3004753838
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- DEXCOM, INC.
- Registration Number
- 3004753838
- FEI Number
- 3004753838
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6340 Sequence Dr
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243214
Owner / Operator
- Firm Name
- DEXCOM, INC.
- Operator Number
- 9071756
- Address
- 6340 Sequence Drive, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Avi Brown
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2025-08-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-08-18 |
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | SAF | Class 2 | Clinical Chemistry | No | 2024-03-19 |
| Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | QII | Class 2 | Clinical Chemistry | No | 2025-11-25 |
| Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | QDK | Class 2 | Clinical Chemistry | No | 2025-11-25 |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | Class 1 | Clinical Chemistry | No | 2016-12-19 |
| Continuous Glucose Monitor Informed Insulin Dose Calculator | QRX | Class 2 | Clinical Chemistry | No | 2025-12-19 |
| Continuous Glucose Monitor Secondary Display | PJT | Class 2 | Clinical Chemistry | No | 2015-02-18 |
Proprietary Names
DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM
Dexcom ONE Continuous Glucose Monitoring System
Dexcom ONE+ Continuous Glucose Monitoring System
Dexcom Overpatch
Dexcom G6 Continuous Glucose Monitoring System
Stelo Glucose Biosensor System
Dexcom G6 Pro Continuous Glucose Monitoring System
Dexcom G7 Continuous Glucose Monitoring System
Dexcom Clarity
Dexcom API
Dexcom Follow
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Device in the United States for Export Only