BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    XERA Medikal Sistemleri ve Teknoloji Ltd. Sti.

    Reg #: 3023190435 · FEI: 3023190435 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    XERA Medikal Sistemleri ve Teknoloji Ltd. Sti.
    Registration Number
    3023190435
    FEI Number
    3023190435
    Status
    Active
    Expiry Year
    2026
    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 Medikal Sistemleri ve Teknoloji Ltd. Sti.
    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
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

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

    Proprietary Names

    GR10X-40K XERA OCTAVE GR10X-50K

    Establishment Types

    Manufacture Medical Device