BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Takeda Manufacturing Austria AG

    Reg #: 9616848 · FEI: 3002669612 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Takeda Manufacturing Austria AG
    Registration Number
    9616848
    FEI Number
    3002669612
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    INDUSTRIESTRASSE 67
    City
    VIENNA Wien
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K072894

    Owner / Operator

    Firm Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Operator Number
    10049748
    Address
    500 Kendall St.
    City
    Cambridge
    State
    MA
    Postal Code
    02142
    Country
    US
    Correspondent
    Shilpa Gampa

    US Agent

    Business Name
    FREYR INC
    Contact Name
    Shilpa Gampa
    Address
    777 Scudders Mill Road, Building 2, Suite 150
    City
    Plainsboro
    State
    NJ
    ZIP
    08536
    Country
    US
    Email
    [email protected]
    Phone
    760 5834401

    Products

    Device Name Product Code
    System/Device, Pharmacy Compounding NEP
    Set, Administration, Intravascular FPA
    Syringe, Piston FMF

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device