BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SIR-Spheres

    Reg #: 3013070673 · FEI: 3013070673 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sirtex Germany Manufacturing GmbH
    Registration Number
    3013070673
    FEI Number
    3013070673
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industriepark Hoechst, Building G808
    City
    Frankfurt am Main Hesse
    Country
    DE

    Regulatory Submissions

    PMA Number
    P990065

    Owner / Operator

    Firm Name
    Sirtex Medical Pty Ltd
    Operator Number
    9047689
    Address
    Shop 6, 207 Pacific Highway
    City
    St Leonards
    State
    New South Wales
    Postal Code
    2065
    Country
    AU

    US Agent

    Business Name
    Sirtex Medical, Inc.
    Contact Name
    Jeffrey Cyr
    Address
    300 Unicorn Park Drive, 2nd Floor
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US
    Email
    [email protected]
    Phone
    781 7213889

    Products

    Device Name Product Code
    Microspheres Radionuclide NAW

    Proprietary Names

    SIR-Spheres SIR-Spheres Select SIR-Spheres Select Y-90 resin microspheres SIR-Spheres microspheres

    Establishment Types

    Manufacture Medical Device