BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Micro Ergo Elite 3.5x, Micro Ergo Elite 5x

    Reg #: 2127132 · FEI: 2127132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ENOVA ILLUMINATION, INC
    Registration Number
    2127132
    FEI Number
    2127132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6305 Sandburg Rd., Suite 100
    City
    Minneapolis
    State
    MN
    ZIP
    55427
    Country
    US

    Owner / Operator

    Firm Name
    Enova Illumination Inc.
    Operator Number
    2127132
    Address
    6305 Sandburg Rd, Suite 100
    City
    Minneapolis
    State
    MN
    Postal Code
    55427
    Country
    US
    Correspondent
    Jeremy H Ward

    Products

    Device Name Product Code
    Loupe, Diagnostic/Surgical FSP

    Proprietary Names

    Micro Ergo Elite 3.5x, Micro Ergo Elite 5x AC-VUE 2.5, MDA-Vue 2.8, SM-Vue 2.8, MD-Vue 2.8, XG-Vue 2.8, XG-Vue 3.8 Vizix Prismatic 3.5, Vizix Prismatic 4.5, Vizix Prismatic 5.5 Vizix 2.5, Vizix 3, Vizix 3.5 DFK Air Angled Loupes 3x, DFK Air Angled Loupes 4x, DFK Air Angled Loupes 5x DFK Angled Loupes 3x, DFK Angled Loupes 4x, DFK Angled Loupes 5x Vizix Ergo 3.5, Vizix Ergo 4.5, Vizix Ergo 5.5

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device