BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C-Arm : Anyview-500R

    Reg #: 1225677 · FEI: 3001451453 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    UMI INTL.
    Registration Number
    1225677
    FEI Number
    3001451453
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    95 Hudson Ave. #3F10
    City
    Norwood
    State
    NJ
    ZIP
    07648
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160279

    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
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO

    Proprietary Names

    C-Arm : Anyview-500R

    Establishment Types

    Repack or Relabel Medical Device