BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EnVisio System

    Reg #: 3014653199 · FEI: 3014653199 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELUCENT MEDICAL INC.
    Registration Number
    3014653199
    FEI Number
    3014653199
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6509 Flying Cloud Drive, Suite 160
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183400

    Owner / Operator

    Firm Name
    Elucent Medical Inc.
    Operator Number
    10057977
    Address
    6509 Flying Cloud Drive, Suite 160
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Judson Guericke

    Products

    Device Name Product Code
    Marker, Radiographic, Implantable NEU

    Proprietary Names

    EnVisio System SmartSensor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device