BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemoSonics, LLC (SC)

    Reg #: 3014240198 · FEI: 3014240198 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HemoSonics, LLC (SC)
    Registration Number
    3014240198
    FEI Number
    3014240198
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4020 Stirrup Creek Drive, Suite 105
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213917

    Owner / Operator

    Firm Name
    HemoSonics, LLC
    Operator Number
    10057901
    Address
    4020 Stirrup Creek Drive, Suite 105
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    Garrett Sparks

    Products

    Device Name Product Code
    Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties QFR

    Proprietary Names

    QStat Cartridge Quantra Hemostasis Analyzer Quantra Desktop Remote Viewer

    Establishment Types

    Manufacture Medical Device