BEUDAMED
    FDA Registration Active 🇷🇴 Romania

    HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010

    Reg #: 3011971979 · FEI: 3011971979 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HAMILTON CENTRAL EUROPE
    Registration Number
    3011971979
    FEI Number
    3011971979
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hamilton Street No 2-4
    City
    Giarmata Timis
    Country
    RO

    Regulatory Submissions

    510(k) Number
    K152029

    Owner / Operator

    Firm Name
    Hamilton Central Europe
    Operator Number
    10053968
    Address
    Hamilton Street No 2-4
    City
    Giarmata
    State
    Timis
    Postal Code
    307210
    Country
    RO
    Correspondent
    Elena Patrut

    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
    775 5165558

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)