BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cytovale System

    Reg #: 3005370583 · FEI: 3005370583 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KORVIS LLC (DBA Ascential Medical & Life Sciences)
    Registration Number
    3005370583
    FEI Number
    3005370583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2101 NE Jack London St
    City
    Corvallis
    State
    OR
    ZIP
    97330
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220991

    Owner / Operator

    Firm Name
    Korvis, LLC (DBA Ascential Medical & Life Sciences)
    Operator Number
    10045146
    Address
    2101 NE Jack London Street
    City
    Corvallis
    State
    OR
    Postal Code
    97330
    Country
    US
    Correspondent
    Jamie Maughan

    Products

    Device Name Product Code
    Deformability Cytometry For Sepsis Risk Assessment QUT

    Proprietary Names

    Cytovale System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)