BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IQM

    Reg #: 3010875109 · FEI: 3010875109 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    iRT Systems GmbH
    Registration Number
    3010875109
    FEI Number
    3010875109
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Schlossstrasse 1
    City
    Koblenz Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K162629

    Owner / Operator

    Firm Name
    iRT Systems GmbH
    Operator Number
    10053403
    Address
    Schlossstrasse 1
    City
    Koblenz
    State
    Rhineland-Palatinate
    Postal Code
    56068
    Country
    DE
    Correspondent
    Thesi Roestel

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    IQM IQM Integral Quality Monitor IQM System Integral Quality Monitor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device