BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rochester

    Reg #: 1063285 · FEI: 1000403400 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Advantage Medical Electronics, LLC, dba AMC
    Registration Number
    1063285
    FEI Number
    1000403400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11705 NW 39th Street
    City
    Coral Springs
    State
    FL
    ZIP
    33065
    Country
    US

    Regulatory Submissions

    510(k) Number
    K990015

    Owner / Operator

    Firm Name
    Advantage Medical Electronics, LLC
    Operator Number
    10023616
    Address
    11705 NW 39th Street
    City
    Coral Springs
    State
    FL
    Postal Code
    33065
    Country
    US

    Products

    Device Name Product Code
    Electrode, Needle, Diagnostic Electromyograph IKT
    Electrode, Needle GXZ

    Proprietary Names

    Rochester

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198