BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Barkey plasmatherm TCP

    Reg #: 3006629881 · FEI: 3006629881 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Barkey GmbH & Co. KG
    Registration Number
    3006629881
    FEI Number
    3006629881
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Im Leuschnerpark 2
    City
    Griesheim Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK100063

    Owner / Operator

    Firm Name
    Barkey GmbH & Co. KG
    Operator Number
    10022966
    Address
    Gewerbestrasse 8
    City
    Leopoldshoehe
    State
    North Rhine-Westphalia
    Postal Code
    33818
    Country
    DE
    Correspondent
    Rob Woodward

    US Agent

    Business Name
    Barkey Corporation (Azenta)
    Contact Name
    Elizabeth Ryan
    Address
    500 W Cummings Park Ste 1900
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US
    Email
    [email protected]
    Phone
    781 7302655

    Products

    Device Name Product Code
    Device, Warming. Blood And Plasma KZL

    Proprietary Names

    Barkey plasmatherm TCP Barkey plasmatherm

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device