BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Distal Cap Models DH-33GR, DH-34CR, DH-40GR, DH-35GZ, DH-37CZ, DH-38CZ, DH-39CZ

    Reg #: 3015746529 · FEI: 3015746529 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Kinjo Rubber Co., Ltd.
    Registration Number
    3015746529
    FEI Number
    3015746529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4-25, 1-Chome, Atobe-Kitanocho
    City
    Yao-City Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K193123

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Avenue, Suite 300
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Gastroscope And Accessories, Flexible/Rigid FDS
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    Distal Cap Models DH-33GR, DH-34CR, DH-40GR, DH-35GZ, DH-37CZ, DH-38CZ, DH-39CZ

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)