BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    t:slim X2 with Basal-IQ technology

    Reg #: 3026266833 · FEI: 3026266833 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Tandem Diabetes Care Europe B.V.
    Registration Number
    3026266833
    FEI Number
    3026266833
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    359 Schiphol Boulevard
    City
    Schiphol Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K201214

    Owner / Operator

    Firm Name
    Tandem Diabetes Care, Inc.
    Operator Number
    10039506
    Address
    12400 High Bluff Drive
    City
    San Diego
    State
    CA
    Postal Code
    92130
    Country
    US
    Correspondent
    Mark Tarby

    US Agent

    Business Name
    TANDEM DIABETES CARE, INC.
    Contact Name
    Mark Tarby
    Address
    12400 High Bluff Drive
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    858 2246319

    Products

    Device Name Product Code
    Alternate Controller Enabled Insulin Infusion Pump QFG

    Proprietary Names

    t:slim X2 with Basal-IQ technology

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device