BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Takeda Pharmaceuticals U.S.A., Inc.

    Reg #: 3016418550 · FEI: 3016418550 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Registration Number
    3016418550
    FEI Number
    3016418550
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    500 Kendall St.
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243404

    Owner / Operator

    Firm Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Operator Number
    10079762
    Address
    500 Kendall St.
    City
    Cambridge
    State
    MA
    Postal Code
    02142
    Country
    US
    Correspondent
    Shilpa Gampa

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI
    Sparse Sample Pk Profile And Dosing Software PHY

    Proprietary Names

    HyHub™ and HyHub™ Duo Vial Access Devices myPKFiT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device