BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Omron Healthcare Manufacturing Vietnam Co., Ltd.

    Reg #: 3006852037 · FEI: 3006852037 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Omron Healthcare Manufacturing Vietnam Co., Ltd.
    Registration Number
    3006852037
    FEI Number
    3006852037
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 28 VSIP II, St. 2, Vietnam-Singapore Industrial Park II, Binh Duong Industry-Service-Urban Complex, Hoa Phu Ward
    City
    Thu Dau Mot City Binh Duong
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K163235

    Owner / Operator

    Firm Name
    OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
    Operator Number
    10023852
    Address
    No. 28 VSIP II, St. 2, Vietnam-Singapore Industrial Park II, Binh Duong Industry-Service-Urban Complex
    City
    Hoa Phu Ward, Thu Dau Mot City
    State
    Binh Duong
    Postal Code
    820000
    Country
    VN
    Correspondent
    Thu Nguyen Minh

    US Agent

    Business Name
    OMRON HEALTHCARE, INC.
    Contact Name
    Terri Ingalls
    Address
    2895 Greenspoint Parkway, Suite 100
    City
    Hoffman Estates
    State
    IL
    ZIP
    60169
    Country
    US
    Email
    [email protected]
    Phone
    847 2475657

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)