BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Sterile Insulin Syringe for Single use, with needle

    Reg #: 3017907716 · FEI: 3017907716 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
    Registration Number
    3017907716
    FEI Number
    3017907716
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt
    City
    esenyurt Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K201284

    Owner / Operator

    Firm Name
    Set Medikal Sanayi Ve Ticaret Anonim Sirketi
    Operator Number
    10079852
    Address
    Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt
    City
    Istanbul
    State
    TR-34
    Postal Code
    34522
    Country
    TR
    Correspondent
    Egemen Serbetci

    US Agent

    Business Name
    One Life Sciences
    Contact Name
    Murat Acar
    Address
    11543 NW 81st Pl
    City
    Parkland
    State
    FL
    ZIP
    33076
    Country
    US
    Email
    [email protected]
    Phone
    702 5768082

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Sterile Insulin Syringe for Single use, with needle Sterile Hypodermic needle for Single use Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Manufacture Medical Device