BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHIRE HUMAN GENETIC THERAPIES, INC.

    Reg #: 3009340644 · FEI: 3009340644 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SHIRE HUMAN GENETIC THERAPIES, INC.
    Registration Number
    3009340644
    FEI Number
    3009340644
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    300 SHIRE WAY
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031861

    Owner / Operator

    Firm Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Operator Number
    10051446
    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
    Syringe, Piston FMF
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB

    Proprietary Names

    Cinryze Baxject II Hi-Flow Needleless Transfer Device Baxject II Needleless Transfer Device Natpara Q-Cliq Pen Natpara Mixing Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility