BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    GR10X-40K

    Reg #: 3023190435 · FEI: 3023190435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    XERA MEDICAL SYSTEMS AND TECHNOLOGY LTD.
    Registration Number
    3023190435
    FEI Number
    3023190435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Inonu Mah. 1730.CAD. NO:5/1
    City
    Yenimahalle Ankara
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K220149

    Owner / Operator

    Firm Name
    Xera Medical Systems and Technology Ltd.
    Operator Number
    10085374
    Address
    Inonu Mah. 1730.CAD. NO:5/1
    City
    Yenimahalle
    State
    Ankara
    Postal Code
    06370
    Country
    TR
    Correspondent
    Hyunsuk Jang

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR

    Proprietary Names

    GR10X-40K GR10X-50K

    Establishment Types

    Manufacture Medical Device