BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Dexcom (Malaysia) Sdn. Bhd.

    Reg #: 3027503105 · FEI: 3027503105 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Dexcom (Malaysia) Sdn. Bhd.
    Registration Number
    3027503105
    FEI Number
    3027503105
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PMT 818, Persiaran Cassia Selatan 3, Taman Perindustrian Batu Kawan
    City
    Bandar Cassia Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K240902

    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

    US Agent

    Business Name
    DEXCOM, INC.
    Contact Name
    Avi Brown
    Address
    6340 Sequence Drive, --
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 2817153

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device