BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Opera

    Reg #: 3012298445 · FEI: 3012298445 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    UNIMOM CO.
    Registration Number
    3012298445
    FEI Number
    3012298445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    110-19, GAJANGSANEOPSEOBUK-RO
    City
    Osan-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190810

    Owner / Operator

    Firm Name
    Unimom Co.
    Operator Number
    10053086
    Address
    110-19, Gajangsaneopseobuk-ro
    City
    Osan-si
    State
    Gyeonggi
    Postal Code
    18102
    Country
    KR
    Correspondent
    Sang Hyun Hong

    US Agent

    Business Name
    Zev Supplies Corp
    Contact Name
    Dina Shanowitz
    Address
    2700 Gateway drive
    City
    Pompano Beach
    State
    FL
    ZIP
    33069
    Country
    US
    Email
    [email protected]
    Phone
    954 8607552

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    Opera Opera eco

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device