BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amsino Healthcare (USA) Inc.

    Reg #: 1417519 · FEI: 1417519 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    Amsino Healthcare (USA) Inc.
    Registration Number
    1417519
    FEI Number
    1417519
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    330 CORPORATE WOODS PARKWAY
    City
    Vernon Hills
    State
    IL
    ZIP
    60061
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201138

    Owner / Operator

    Firm Name
    Amsino Healthcare (USA) Inc.
    Operator Number
    10058949
    Address
    330 Corporate Woods Parkway
    City
    Vernon Hills
    State
    IL
    Postal Code
    60061
    Country
    US
    Correspondent
    Esteban Encarnacion

    Products

    Device Name Product Code
    Lavage, Jet FQH
    Dressing, Wound, Drug FRO
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    Irrisept Antimicrobial Wound Lavage

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device