BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    AURA 10 PET CT

    Reg #: 3021616442 · FEI: 3021616442 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ST ENGINEERING IDIRECT
    Registration Number
    3021616442
    FEI Number
    3021616442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Joseph Cardijnstraat 10
    City
    Erpe-Mere Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K231420

    Owner / Operator

    Firm Name
    ST Engineering Idirect
    Operator Number
    10092724
    Address
    Joseph Cardijnstraat 10
    City
    Erpe-Mere
    State
    Oost-Vlaanderen
    Postal Code
    9420
    Country
    BE
    Correspondent
    Tim Van Vaerenberg

    US Agent

    Business Name
    Alexandra (Smith) BESCHI
    Contact Name
    Alexandra Beschi
    Address
    13861 Sunrise Valley Dr Ste 300
    City
    Herndon
    State
    VA
    ZIP
    20171
    Country
    US
    Email
    [email protected]
    Phone
    703 6488000

    Products

    Device Name Product Code
    Cabinet, Emission Computed Tomography System QXL
    Cabinet, X-Ray System MWP

    Proprietary Names

    AURA 10 PET CT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)