BEUDAMED
    FDA Registration Active 🇺🇸 United States

    28mm Trans-Septal Mitral Heart Valve, LAV

    Reg #: 3010410494 · FEI: 3010410494 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HighLife Medical
    Registration Number
    3010410494
    FEI Number
    3010410494
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12 Goodyear Ste 125
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Owner / Operator

    Firm Name
    HighLife Medical
    Operator Number
    10050888
    Address
    12 Goodyear, Suite 125
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Eric S Simon

    Products

    Device Name Product Code
    Replacement Heart-Valve DYE

    Proprietary Names

    28mm Trans-Septal Mitral Heart Valve, LAV Clarity Trans-Septal Mitral Heart Valve 28mm Trans-Septal Mitral Heart Valve Clarity Trans-Septal Mitral Heart Valve, LAV

    Establishment Types

    Manufacture Device in the United States for Export Only