BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Stealth Chamber, CC04, CC08, CC-13S, CC13, CC25, FC23-C,

    Reg #: 9614952 · FEI: 3006653576 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IBA Dosimetry GmbH
    Registration Number
    9614952
    FEI Number
    3006653576
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bahnhofstrasse 5
    City
    SCHWARZENBRUCK Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K945321

    Owner / Operator

    Firm Name
    IBA Dosimetry GmbH
    Operator Number
    9011908
    Address
    BAHNHOFSTRASSE 5, --
    City
    SCHWARZENBRUCK
    State
    Bavaria
    Postal Code
    D-90592
    Country
    DE
    Correspondent
    Andreas - Suchi

    US Agent

    Business Name
    IBA Dosimetry America, Inc.
    Contact Name
    Nick Narloch
    Address
    470 SPRINGPARK PLACE, SUITE #700
    City
    Herndon
    State
    VA
    ZIP
    20170
    Country
    US
    Email
    [email protected]
    Phone
    901 8055767

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Stealth Chamber, CC04, CC08, CC-13S, CC13, CC25, FC23-C, with different detectors: Semiconductor detectors and chambers: NACP, CC13, FC65-P, FC65-G, PPC05, PPC40 Razor Chamber, Razor Nanochamber, Razor Detector, including accessories: Lift Table, Water reservoir Blue Phantom 2, Blue Phantom Helix, Blue Phantom Compact, Blue Phantom SmartScan

    Establishment Types

    Manufacture Medical Device