BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    URUS

    Reg #: 3032578846 · FEI: 3032578846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DYNE MEDICAL GROUP INC.
    Registration Number
    3032578846
    FEI Number
    3032578846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #1001-1013, #1015-1016, #1024-1025, 10F, 165, Gimpohangang 10-ro 133beon-gil,
    City
    Gimpo- si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240203

    Owner / Operator

    Firm Name
    DYNE Medical Group Inc.
    Operator Number
    10091398
    Address
    #1001, 10F, 165, Gimpohangang 10-ro 133beon-gil
    City
    Gimpo- si
    State
    Gyeonggi
    Postal Code
    10071
    Country
    KR

    US Agent

    Business Name
    Provision Consulting Group, Inc.
    Contact Name
    Joyce Kwon
    Address
    13925 City Center Dr Ste 200
    City
    Chino Hills
    State
    CA
    ZIP
    91709
    Country
    US
    Email
    [email protected]
    Phone
    909 4933276

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB

    Proprietary Names

    URUS URUS System

    Establishment Types

    Manufacture Medical Device