BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    XLINE SRL

    Reg #: 3003528079 · FEI: 3003528079 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    XLINE SRL
    Registration Number
    3003528079
    FEI Number
    3003528079
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA GALILEI 18
    City
    ASSAGO Milano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K031118

    Owner / Operator

    Firm Name
    XLINE S.r.l.
    Operator Number
    10061120
    Address
    Via Galilei 18
    City
    Assago
    State
    Milano
    Postal Code
    20057
    Country
    IT
    Correspondent
    Luigi Germano

    Products

    Device Name Product Code
    Unit, X-Ray, Extraoral With Timer EHD
    X-Ray, Tomography, Computed, Dental OAS
    System, X-Ray, Extraoral Source, Digital MUH
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    IntraOs 70 IntraOs DG Vario DG Stellaris 3D Ceph Stellaris 2D Stellaris 2D Ceph Stellaris 3D PantOs 16 xp Ceph PantOs DG xp PantOs 16 xp StarX-1 StarX PRO-1 StarX-2 StarX PRO-2 FONA ART Plus FONA XPan DG FONA XPan DG Plus FONA ART Plus C FONA XDC

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198