BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    INOUE BALLOON CATHETER

    Reg #: 9612812 · FEI: 3002808331 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TORAY INDUSTRIES, INC. SETA PLANT
    Registration Number
    9612812
    FEI Number
    3002808331
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1, OE 1-CHOME
    City
    OTSU Shiga
    Country
    JP

    Regulatory Submissions

    PMA Number
    P910054

    Owner / Operator

    Firm Name
    TORAY INDUSTRIES, INC. SETA PLANT
    Operator Number
    9021655
    Address
    1-1, OE 1-CHOME
    City
    OTSU
    State
    Shiga
    Postal Code
    520-2141
    Country
    JP

    US Agent

    Business Name
    Toray Industries (America), Inc.
    Contact Name
    YUYA SHIZUME
    Address
    1251 AVENUE OF THE AMERICAS, SUITE 930
    City
    New York
    State
    NY
    ZIP
    10020
    Country
    US
    Email
    [email protected]
    Phone
    212 6978150

    Products

    Device Name Product Code
    Catheter, Percutaneous (Valvuloplasty) MAD

    Proprietary Names

    INOUE BALLOON CATHETER

    Establishment Types

    Manufacture Medical Device