BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AIRGLE CORPORATION

    Reg #: 3030650766 · FEI: 3030650766 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AIRGLE CORPORATION
    Registration Number
    3030650766
    FEI Number
    3030650766
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1170 Lincoln Avenue Unit 2
    City
    Holbrook
    State
    NY
    ZIP
    11741
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232645

    Owner / Operator

    Firm Name
    Airgle Corporation
    Operator Number
    10090237
    Address
    1170 Lincoln Avenue Unit 2 Holbrook, NY 11741 USA
    City
    Holbrook
    State
    NY
    Postal Code
    11741
    Country
    US
    Correspondent
    jerry liu

    Products

    Device Name Product Code
    Saw, Manual And Accessories GDR
    Purifier, Air, Ultraviolet, Medical FRA

    Proprietary Names

    Airgle Extraoral Dental Smart FlexHose, Models: AG600D, AG900D Airgle Room Air Purifier, Models: AG300, AG300S, AG300L, AG300E, AG320, AG320S, AG320L, AG320E Airgle Room Air Purifier, Models: AG600, AG600S, AG600L, AG600E, AG700, AG700S, AG700L, AG700E Airgle Clean Room Air Purifier, Models: AG900, AG900S, AG900L, AG900E, AG930, AG930S, AG930L, AG930E

    Establishment Types

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