BEUDAMED
    FDA Registration Active 🇺🇸 United States

    exoplan

    Reg #: 3013718526 · FEI: 3013718526 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EXOCAD AMERICA, INC.
    Registration Number
    3013718526
    FEI Number
    3013718526
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7 Wheeling Ave #1
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183458

    Owner / Operator

    Firm Name
    exocad GmbH
    Operator Number
    10055196
    Address
    Rosa-Parks-Str. 2
    City
    Darmstadt
    State
    Hesse
    Postal Code
    64295
    Country
    DE
    Correspondent
    Stefan O Walter

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    exoplan

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198