BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Advisor HD Grid Mapping Catheter, Sensor Enabled

    Reg #: 3034205957 · FEI: 3034205957 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    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
    K172393

    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
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Catheter, Intracardiac Mapping, High-Density Array MTD

    Proprietary Names

    Advisor HD Grid Mapping Catheter, Sensor Enabled

    Establishment Types

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