BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ON3D

    Reg #: 3023266032 · FEI: 3023266032 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3D ONS, INC.
    Registration Number
    3023266032
    FEI Number
    3023266032
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18, Eonju-ro 171-gil
    City
    Gangnam-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K221000

    Owner / Operator

    Firm Name
    3D ONS, Inc.
    Operator Number
    10085447
    Address
    18, Eonju-ro 171-gil
    City
    Gangnam-gu
    State
    Seoul
    Postal Code
    06023
    Country
    KR
    Correspondent
    HeonJae Cho

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    SEOK WOO KIM
    Address
    5450 ASTOR LANE #203
    City
    Rolling Mdws
    State
    IL
    ZIP
    60008
    Country
    US
    Email
    [email protected]
    Phone
    847 9241545

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    ON3D

    Establishment Types

    Manufacture Medical Device