BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALC ENTERPRISES INC

    Reg #: 3011721071 · FEI: 3011721071 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    ALC ENTERPRISES INC
    Registration Number
    3011721071
    FEI Number
    3011721071
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    134 Stockton Street, 1C
    City
    Brooklyn
    State
    NY
    ZIP
    11206
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140211

    Owner / Operator

    Firm Name
    Aura Medical LLC
    Operator Number
    10049729
    Address
    2 Skillman Street, Suite 512
    City
    Brooklyn
    State
    NY
    Postal Code
    11205
    Country
    US
    Correspondent
    Connie Lefkowitz

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Electrocardiograph DPS
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Scaler, Periodontic EMN
    Media, Electroconductive GYB
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Oximeter DQA

    Proprietary Names

    Illumine Scaler GLIDE ON GEL Caring Mill By Aura Serene Jumper Pulse Oximeter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device