BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    KOALA

    Reg #: 3016965352 · FEI: 3016965352 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    IB LAB GMBH
    Registration Number
    3016965352
    FEI Number
    3016965352
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zehetnergasse 6/2/2
    City
    Vienna Wien
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K192109

    Owner / Operator

    Firm Name
    IB Lab GmbH
    Operator Number
    10074574
    Address
    Zehetnergasse 6/2/2
    City
    Vienna
    State
    Wien
    Postal Code
    1140
    Country
    AT
    Correspondent
    Richard Ljuhar

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Image Processing, Radiological LLZ

    Proprietary Names

    KOALA

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198