BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UMI INTL.

    Reg #: 1225677 · FEI: 3001451453 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    9

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    Registration Details

    Registration Name
    UMI INTL.
    Registration Number
    1225677
    FEI Number
    3001451453
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    95 Hudson Ave. #3F10
    City
    Norwood
    State
    NJ
    ZIP
    07648
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180473

    Owner / Operator

    Firm Name
    UMI INTL.
    Operator Number
    9030079
    Address
    95 Hudson Ave. #3F10
    City
    Norwood
    State
    NJ
    Postal Code
    07648
    Country
    US
    Correspondent
    KWANG CHAE - JUNG

    Products

    Device Name Product Code
    Tube Mount, X-Ray, Diagnostic IYB
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Grid, Radiographic IXJ
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    System, X-Ray, Film Marking, Radiographic JAC
    Table, Radiologic KXJ
    System, X-Ray, Mobile IZL

    Proprietary Names

    Tube Stand C-Arm : Anyview-500DR X-ray Grid HFG( SXG-Series ) Bucky Stand Patient Table Portable Unit C-Arm : Anyview-500R

    Establishment Types

    Repack or Relabel Medical Device