BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GE Innova IGS Cath Angio

    Reg #: 3014343100 · FEI: 3014343100 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    EVERX JAPAN CO. LTD
    Registration Number
    3014343100
    FEI Number
    3014343100
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F Kowa Kawasaki Nishiguchi Building, 66-2 Horikawa-Cho, Saiwai-Ku
    City
    Kawasaki Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K122457

    Owner / Operator

    Firm Name
    Everx Japan Co. Ltd
    Operator Number
    10064022
    Address
    1F Kowa Kawasaki Nishiguchi Building, 66-2 Horikawa-Cho, Saiwai-Ku
    City
    Kawasaki
    State
    Kanagawa
    Postal Code
    2120013
    Country
    JP

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Angiographic IZI
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    GE Innova IGS Cath Angio

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device