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    FDA Registration Active 🇨🇭 Switzerland

    Hamilton Medical AG

    Reg #: 3029906224 · FEI: 3029906224 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    Hamilton Medical AG
    Registration Number
    3029906224
    FEI Number
    3029906224
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parc Industrial Vial 12
    City
    Domat/Ems Graubunden
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K152029

    Owner / Operator

    Firm Name
    Hamilton Medical AG
    Operator Number
    10059168
    Address
    Via Crusch 8
    City
    Bonaduz
    State
    Graubunden
    Postal Code
    7402
    Country
    CH
    Correspondent
    Annemarie Hoeft

    US Agent

    Business Name
    Hamilton Medical, Inc.
    Contact Name
    Kyle Hofer
    Address
    201 Edison Way
    City
    Reno
    State
    NV
    ZIP
    89502
    Country
    US
    Email
    [email protected]
    Phone
    800 4516478 ext. 6004

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Compressor, Air, Portable BTI
    Ventilator, Continuous, Facility Use CBK
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Tubing, Pressure And Accessories BYX
    Oximeter DQA
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Cuff, Tracheal Tube, Inflatable BSK
    Set, Tubing And Support, Ventilator (W Harness) BZO

    Proprietary Names

    HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 Ventilair II Medical Air Compressor HAMILTON-C6 HAMILTON-MR1 HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 Expiratory valve set , reusable, PN 161175, PN 161188, PN 151972, PN 160245 Expiratory valve set , single use, PN 160176, PN 161186, PN 161189, PN 950158 Flow sensor, single use, neonatal PN 260179, PN 260177, PN 155500 Flow sensor, single use, neonatal/adult/pediatric PN 282049 Flow sensor, single use, adult/pediatric PN 282051, PN 281637, PN 950185 HAMILTON-T1, HAMILTON-C1 HAMILTON-G5 HAMILTON-C3 HAMILTON-C2 IntelliCuff Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206 Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087 Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 260169, PN 260170 Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257 Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device