BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    TheraSphere

    Reg #: 8022247 · FEI: 3001092088 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BWXT MEDICAL LTD.
    Registration Number
    8022247
    FEI Number
    3001092088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    447 MARCH RD.
    City
    OTTAWA Ontario
    Country
    CA

    Regulatory Submissions

    PMA Number
    P200029

    Owner / Operator

    Firm Name
    BWXT MEDICAL LTD.
    Operator Number
    10061054
    Address
    447 March Road, Mail Stn 7A
    City
    Ottawa
    State
    Ontario
    Postal Code
    K2K 1X8
    Country
    CA
    Correspondent
    Tapashi Dasgupta

    US Agent

    Business Name
    PARAXEL INTERNATIONAL
    Contact Name
    ALLY DANTA
    Address
    2520 Meridian Parkway,, Suite 200
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    978 3132406

    Products

    Device Name Product Code
    Microspheres Radionuclide NAW

    Proprietary Names

    TheraSphere

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)