BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    ROOT Breast Pump S12Pro

    Reg #: 3030978471 · FEI: 3030978471 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOI(VIETNAM) COMPANY LIMITED
    Registration Number
    3030978471
    FEI Number
    3030978471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot CN-16 Viet Han Industrial Park, Tang Tien Ward
    City
    Viet Yen Bac Giang
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K230776

    Owner / Operator

    Firm Name
    BOI(Vietnam) Company Limited
    Operator Number
    10062197
    Address
    Lot CN-16 Viet Han Industrial Park, Tang Tien Ward
    City
    Viet Yen
    State
    Bac Giang
    Postal Code
    26000
    Country
    VN
    Correspondent
    Sum Wing Lee

    US Agent

    Business Name
    PETER TAM-ENGINEERING CONSULTANT
    Contact Name
    Peter Tam
    Address
    11217 Black Fire Opal Dr
    City
    Las Vegas
    State
    NV
    ZIP
    89138
    Country
    US
    Email
    [email protected]
    Phone
    949 4000888

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    ROOT Breast Pump S12Pro

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)