BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    XIRALITE FLOURESCENCE IMAGING SYSTEM X4

    Reg #: 3014321789 · FEI: 3014321789 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    XIRALITE GMBH
    Registration Number
    3014321789
    FEI Number
    3014321789
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Robert-Koch-Platz 4
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K130003

    Owner / Operator

    Firm Name
    Xiralite GmbH
    Operator Number
    10056880
    Address
    Robert-Koch-Platz 4
    City
    Berlin
    State
    DE-BE
    Postal Code
    10115
    Country
    DE
    Correspondent
    Miroslava Racheva

    US Agent

    Business Name
    German American Chamber of Commerce, Inc.
    Contact Name
    German American Chamber of Commerce, Inc. German American Ch
    Address
    80 Pine Street, 24th Floor
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    212 9748830

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    Confocal Optical Imaging OWN

    Proprietary Names

    XIRALITE FLOURESCENCE IMAGING SYSTEM X4

    Establishment Types

    Manufacture Medical Device