BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TORAY INDUSTRIES, INC.

    Reg #: 9614758 · FEI: 3002710305 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TORAY INDUSTRIES, INC.
    Registration Number
    9614758
    FEI Number
    3002710305
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-1, NIHONBASHI-MUROMACHI 2-CHOME
    City
    CHUO-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K220881
    PMA Number
    P910054

    Owner / Operator

    Firm Name
    TORAY INDUSTRIES, INC.
    Operator Number
    9037937
    Address
    1-1, NIHONBASHI-MUROMACHI 2-CHOME
    City
    CHUO-KU
    State
    Tokyo
    Postal Code
    103-8666
    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
    Balloon Aortic Valvuloplasty OZT
    Wire, Guide, Catheter DQX

    Proprietary Names

    Inoue Balloon Catheter INOUE BALLOON A TORAYGUIDE GUIDEWIRE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility