BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

    Reg #: 3001421318 · FEI: 3001421318 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HAMILTON MEDICAL AG
    Registration Number
    3001421318
    FEI Number
    3001421318
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA CRUSCH 8
    City
    BONADUZ Graubunden
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K163283

    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
    Sachin Thanawala
    Address
    201 Edison Way
    City
    Reno
    State
    NV
    ZIP
    89502
    Country
    US
    Email
    [email protected]
    Phone
    800 4266331 ext. 210

    Products

    Device Name Product Code
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device