BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    ISYS Medizintechnik GmbH

    Reg #: 3013035022 · FEI: 3013035022 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISYS Medizintechnik GmbH
    Registration Number
    3013035022
    FEI Number
    3013035022
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bergwerksweg 21
    City
    Kitzbuehel Salzburg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K203720

    Owner / Operator

    Firm Name
    ISYS Medizintechnik GmbH
    Operator Number
    10052093
    Address
    Bergwerksweg 21
    City
    Kitzbuehel
    State
    Salzburg
    Postal Code
    6370
    Country
    AT

    US Agent

    Business Name
    Dawa Medical
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Restraint, Protective FMQ
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    IFix Micromate

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility