BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dexcom, Inc.

    Reg #: 3013435121 · FEI: 3013435121 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Dexcom, Inc.
    Registration Number
    3013435121
    FEI Number
    3013435121
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    232 South Dobson Road
    City
    Mesa
    State
    AZ
    ZIP
    85202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221259

    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
    Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use QII
    Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management QDK
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Tape And Bandage, Adhesive KGX
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF

    Proprietary Names

    Dexcom G6 Pro Continuous Glucose Monitoring System Dexcom G7 Continuous Glucose Monitoring System Dexcom G6 Continuous Glucose Monitoring System Dexcom ONE Continuous Glucose Monitoring System Dexcom ONE+ Continuous Glucose Monitoring System Stelo Glucose Biosensor System DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only