BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    XIRALITE GMBH

    Reg #: 3014321789 · FEI: 3014321789 · Expires 2026
    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
    2026
    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

    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