BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Sirtex Singapore Manufacturing Pte Ltd

    Reg #: 3009088444 · FEI: 3009088444 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    Sirtex Singapore Manufacturing Pte Ltd
    Registration Number
    3009088444
    FEI Number
    3009088444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 Science Park Road, #01-01, Science Park II
    City
    Singapore Central Singapore
    Country
    SG

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

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device