BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEMEDEX INCORPORATED

    Reg #: 3003730855 · FEI: 3003730855 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    HEMEDEX INCORPORATED
    Registration Number
    3003730855
    FEI Number
    3003730855
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    564 Main Street, Suite 300
    City
    North Waltham
    State
    MA
    ZIP
    02452
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141869

    Owner / Operator

    Firm Name
    HEMEDEX INCORPORATED
    Operator Number
    9048090
    Address
    564 Main Street, Suite 300
    City
    Waltham
    State
    MA
    Postal Code
    02452
    Country
    US
    Correspondent
    Timothe - Martin

    Products

    Device Name Product Code
    Accessories, Catheter KGZ
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Device, Monitoring, Intracranial Pressure GWM
    Flowmeter, Blood, Cardiovascular DPW

    Proprietary Names

    QFLOW 500TM Accessories, Repositioning Sleeve QFLOW 500TM TITANIUM BOLT Single Lumen QFLOW 500TM TITANIUM BOLT Single Lumen Bolt Kit with Dura Piercer QFLOW 500TM Accessories, Touhy Borst / Compression Fitting 0-9 FR QFLOW 500TM Accessories, Bolt Accessories Kit QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit with Introducer QFLOW 500TM TITANIUM BOLT Quad Lumen Bolt Kit QFLOW 500TM TITANIUM BOLT Dual Lumen QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit QFLOW 500TM 5.3 mm Cranial Drill Bit QFLOW 500TM 2.7 mm Cranial Drill Bit QFLOW 500TM Accessories, Large Lumen Introducer QFLOW 500TM Accessories, Male Luer Coupler QFLOW 500TM Accessories, Male Luer Cap/Sealing Cap QFLOW 500TM Accessories, Probe Dura Piercer and Introducer Kit Bowman Perfusion Monitor® QFLOW 500TM Perfusion Probe

    Establishment Types

    Manufacture Medical Device