BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Fiagon GMBH

    Reg #: 3010313588 · FEI: 3010313588 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    40
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Fiagon GMBH
    Registration Number
    3010313588
    FEI Number
    3010313588
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Neuendorfstr. 23b
    City
    Hennigsdorf Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K141456

    Owner / Operator

    Firm Name
    Fiagon GmbH
    Operator Number
    10046786
    Address
    Neuendorfstr. 23b
    City
    Hennigsdorf
    State
    Brandenburg
    Postal Code
    16761
    Country
    DE

    US Agent

    Business Name
    Fiagon NA
    Contact Name
    Matthew Jones
    Address
    3913 Todd Lane, Suite 101
    City
    Austin
    State
    TX
    ZIP
    78744
    Country
    US
    Email
    [email protected]
    Phone
    512 3838580

    Products

    Device Name Product Code
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Instrument, Ent Manual Surgical LRC
    Eustachian Tube Balloon Dilation Device PNZ
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    FlexTube 4 mm PointerShell 4 mm PointerShell 3 mm PointerShell 5 mm RegistrationPointer FlexTube 3 mm FlexTube 3 Single Use FlexPointer 1.5 Single Use FlexPointer 1.5 GuideWire 0.6 Single Use VirtuEye Navigation Sensor NanoRest Cube Navigation System Navigation Unit Cube 4D VenSure 4D Balloon Dilation System VenSure Nav Balloon Dilation System VenSure Balloon Dilation System VenSure Light Balloon Dilation System VenSure ET Balloon Dilation System FlexPointer Fiagon Navigation System FinePointer Localizer Adhesive pad C-Type RIWOtrack Flexsensor Localizer K-Wire MapperBridge Adapter for Clipsensor Navigation Sensor Flexarm MultiPad RIWOtrack Cube4D RIWOtrack Clipsensor Adapter for Flexsensor RIWOtrack Navigation System PointerShell LS PointerShell Universal PointerTube Kennedy PointerTube Keat VenSure Nav Balloon Dilation Device VenSure Balloon Dilation Device VenSure Light Balloon Dilation Device

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility