BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OnyxCeph

    Reg #: 3026391019 · FEI: 3026391019 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMAGE INSTRUMENTS GMBH
    Registration Number
    3026391019
    FEI Number
    3026391019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Niederwaldstr. 3
    City
    Chemnitz Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K213263

    Owner / Operator

    Firm Name
    Image Instruments GmbH
    Operator Number
    10087224
    Address
    Niederwaldstr. 3
    City
    Chemnitz
    State
    Saxony
    Postal Code
    09123
    Country
    DE
    Correspondent
    Rolf Kuehnert

    US Agent

    Business Name
    Regulatory Specialists, Inc.
    Contact Name
    Greg Holland
    Address
    3722 Ave Sausalito
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US
    Email
    [email protected]
    Phone
    949 4224514 ext. 0

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Orthodontic Software PNN

    Proprietary Names

    OnyxCeph

    Establishment Types

    Manufacture Medical Device