BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    IABP7Fr

    Reg #: 3013320573 · FEI: 3013320573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TOKAI MEDICAL PRODUCTS
    Registration Number
    3013320573
    FEI Number
    3013320573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    210-3 Motogosho, Otomi, Izumi-cho
    City
    Toki-City Gifu
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K082746

    Owner / Operator

    Firm Name
    Tokai Medical Products,Inc.
    Operator Number
    10058070
    Address
    1485 Sarayashiki, Taraga-cho
    City
    Kasugai-city
    State
    Aichi
    Postal Code
    486-0808
    Country
    JP
    Correspondent
    Takashi Kumeno

    US Agent

    Business Name
    Insightra Medical Inc. Tennessee Medical Innovations, Inc.
    Contact Name
    Sandie Hetland
    Address
    141 Hatcher Lane
    City
    Clarksville
    State
    TN
    ZIP
    37043
    Country
    US
    Email
    [email protected]
    Phone
    931 8010576

    Products

    Device Name Product Code
    System, Balloon, Intra-Aortic And Control DSP

    Proprietary Names

    IABP7Fr

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)