BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    AURA 10 PET CT

    Reg #: 3027847687 · FEI: 3027847687 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    XEOS MEDICAL
    Registration Number
    3027847687
    FEI Number
    3027847687
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kortrijksesteenweg 1084 bus 301
    City
    Sint-Denijs-Westrem Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K231420

    Owner / Operator

    Firm Name
    XEOS Medical
    Operator Number
    10088583
    Address
    Kortrijksesteenweg 1084 bus 301
    City
    Sint-Denijs-Westrem
    State
    Oost-Vlaanderen
    Postal Code
    9051
    Country
    BE
    Correspondent
    Phebe De Coene

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

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

    Proprietary Names

    AURA 10 PET CT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility