BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AMTRION GMBH (formerly Haseke & Kroemker)

    Reg #: 3005285078 · FEI: 3005285078 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    AMTRION GMBH (formerly Haseke & Kroemker)
    Registration Number
    3005285078
    FEI Number
    3005285078
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sandtrift 1
    City
    Porta Westfalica North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K072136

    Owner / Operator

    Firm Name
    Amtrion GmbH
    Operator Number
    10082386
    Address
    Sandtrift 1
    City
    Porta Westfalica
    State
    North Rhine-Westphalia
    Postal Code
    32457
    Country
    DE
    Correspondent
    Leonhard Gellermann

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Operating Room Accessories Table Tray FWZ
    Table, Operating-Room, Ac-Powered FQO
    Microscope, Surgical EPT
    Stand, Infusion FOX
    Support, Breathing Tube JAY

    Proprietary Names

    Ultra Sonic - USA Claws SKYDOQ Spring Arm5 SKYDOQ Wall Mount FA24 SKYDOQ Central Axis SKYDOQ Spring Arm24 SKYDOQ Monitor Carrier for Spring Arms 28272GM VERSACRANE Light UR300 28272GS Chapot® Table System Support Arm: Vario Lock Support Arm: Quick Lock Support Arm: Oval Nooks

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)