BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Black Lightning Gloves - Small, Medium

    Reg #: 3010363542 · FEI: 3010363542 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EIKON DEVICE INC.
    Registration Number
    3010363542
    FEI Number
    3010363542
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    689 Innovation Drive
    City
    Kingston Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K090194

    Owner / Operator

    Firm Name
    Eikon Device Inc.
    Operator Number
    10044469
    Address
    689 Innovation Drive
    City
    Kingston
    State
    Ontario
    Postal Code
    K7K7E6
    Country
    CA
    Correspondent
    Dean Byrnes

    US Agent

    Business Name
    FDAIMPORTS LLC
    Contact Name
    FDAIMPORTS.COM LLC
    Address
    2631 Housley Road, #1211
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 2202800

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Black Lightning Gloves - Small, Medium

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device