BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Stelo Glucose Biosensor System

    Reg #: 3027503105 · FEI: 3027503105 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dexcom (Malaysia) Sdn. Bhd.
    Registration Number
    3027503105
    FEI Number
    3027503105
    Status
    Active
    Expiry Year
    2025
    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
    K234070

    Owner / Operator

    Firm Name
    DEXCOM, INC.
    Operator Number
    9071756
    Address
    6340 Sequence Drive, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Tim Peterson

    US Agent

    Business Name
    Dexcom, Inc.
    Contact Name
    Tim Peterson
    Address
    6340 Sequence Drive, --
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 5294548

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF

    Proprietary Names

    Stelo Glucose Biosensor System

    Establishment Types

    Manufacture Medical Device