BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Sirtex Germany Manufacturing GmbH

    Reg #: 3013070673 · FEI: 3013070673 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    Sirtex Germany Manufacturing GmbH
    Registration Number
    3013070673
    FEI Number
    3013070673
    Status
    Active
    Expiry Year
    2026
    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 Inc.
    Operator Number
    9047689
    Address
    300 Unicorn Park Dr., 2nd Fl.
    City
    Woburn
    State
    MA
    Postal Code
    01801
    Country
    US
    Correspondent
    Jeffrey Cyr

    US Agent

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

    Products

    Device Name Product Code
    Microspheres Radionuclide NAW
    Holder, Syringe, Lead IWR
    System, Applicator, Radionuclide, Manual IWJ
    Shield, Vial IWW
    Shield, Protective, Personnel KPY

    Proprietary Names

    SIR-Spheres SIR-Spheres Select Y-90 resin microspheres SIR-Spheres Select SIR-Spheres microspheres Syringe Shield SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIR-Spheres V-Vial SIROS Delivery Set V-Vial SIROS D-Vial Prep Set SIR-Spheres V-Vial Holder SIR-Spheres Delivery Box SIROS Delivery Dome

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device