BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    OBTRYX SYSTEM - HALO

    Reg #: 3034205957 · FEI: 3034205957 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GLOBAL MEDICAL INNOVATIONS MEDIKAL URUNLER LTD.STI
    Registration Number
    3034205957
    FEI Number
    3034205957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cevizli Mah. Enderun Sok. No : 10C Nursanlar 3 Plaza K:2 D : 10
    City
    Kartal Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K040787

    Owner / Operator

    Firm Name
    GLOBAL MEDICAL INNOVATIONS MEDIKAL URUNLER LTD.STI
    Operator Number
    10092248
    Address
    Cevizli Mah. Enderun Sok. No : 10C Nursanlar 3 Plaza K:2 D : 10
    City
    Kartal
    State
    Istanbul
    Postal Code
    34870
    Country
    TR
    Correspondent
    Melek DUZGUN

    Products

    Device Name Product Code
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN

    Proprietary Names

    OBTRYX SYSTEM - HALO

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device