BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PolyVue HD2

    Reg #: 3004146030 · FEI: 3004146030 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTEROJO INC.
    Registration Number
    3004146030
    FEI Number
    3004146030
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28& 25 Sandan-ro 15 beon-gil
    City
    PYONGTAEK-CITY Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K080794

    Owner / Operator

    Firm Name
    INTEROJO INC.
    Operator Number
    9058386
    Address
    28 & 25 Sandan-ro 15beon-gil, --
    City
    PYONGTAEK-CITY, KYONGGI-DO
    State
    KR-NOTA
    Postal Code
    459040
    Country
    KR

    US Agent

    Business Name
    EYEREG CONSULTING, INC.
    Contact Name
    BRET ANDRE
    Address
    6119 Canter Ln
    City
    West Linn
    State
    OR
    ZIP
    97068
    Country
    US
    Email
    [email protected]
    Phone
    503 3725226

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    PolyVue HD2 PolyVue HDX2

    Establishment Types

    Manufacture Medical Device