BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MinXray HF100H+

    Reg #: 9610982 · FEI: 3002807605 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIKASA X-RAY CO., LTD.
    Registration Number
    9610982
    FEI Number
    3002807605
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-10-5, Koishikawa
    City
    Bunkyo-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K052721

    Owner / Operator

    Firm Name
    MIKASA X-RAY CO., LTD.
    Operator Number
    8030220
    Address
    5-10-5, KOISHIKAWA, BUNKYO-KU, --
    City
    TOKYO
    State
    JP-13
    Postal Code
    112-0002
    Country
    JP
    Correspondent
    SHUJI - SHINAGAWA

    US Agent

    Business Name
    MINXRAY, INC.
    Contact Name
    KEITH KRETCHMER
    Address
    3611 COMMERCIAL AVE.
    City
    NORTHBROOK
    State
    IL
    ZIP
    60062
    Country
    US
    Email
    [email protected]
    Phone
    847 5640323 ext. 0

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL

    Proprietary Names

    MinXray HF100H+

    Establishment Types

    Manufacture Medical Device