BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Parietex Composite Mesh (PCO and PCO-OS references)

    Reg #: 3014479313 · FEI: 3014479313 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
    Registration Number
    3014479313
    FEI Number
    3014479313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
    City
    Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K173796

    Owner / Operator

    Firm Name
    SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
    Operator Number
    10089530
    Address
    NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
    City
    Istanbul
    State
    TR-34
    Postal Code
    34758
    Country
    TR

    US Agent

    Business Name
    Liberty Management Group Ltd.
    Contact Name
    Manoj Zacharias
    Address
    75 Executive Drive,, Suite 114,
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL

    Proprietary Names

    Parietex Composite Mesh (PCO and PCO-OS references) Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh) Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh),

    Establishment Types

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