BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EIGEN

    Reg #: 2937707 · FEI: 2937707 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    EIGEN
    Registration Number
    2937707
    FEI Number
    2937707
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13366 Grass Valley Ave, Suite A
    City
    Grass Valley
    State
    CA
    ZIP
    95945
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173744

    Owner / Operator

    Firm Name
    Eigen
    Operator Number
    2937707
    Address
    13366 GRASS VALLEY AVE.Suite A, --
    City
    Grass Valley
    State
    CA
    Postal Code
    95945
    Country
    US
    Correspondent
    William R Mandel

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Radiological Image Processing Software For Ablation Therapy Planning And Evaluation QTZ
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    ProFuse / ProFuse CAD Artemis ProFuse Artemis 2 HD Artemis-TPOS

    Establishment Types

    Manufacture Medical Device