BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Smart Otoscope Ear, Nose&Throat HD Camera (Model: 70676-TY)

    Reg #: 3022946813 · FEI: 3022946813 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD
    Registration Number
    3022946813
    FEI Number
    3022946813
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Factory No. 6, Lot CN8, Thach That - Quoc Oai Industrial Park, Phung Xa Commune, Thach That District, Hanoi Ci
    City
    Hanoi Ha Noi
    Country
    VN

    Owner / Operator

    Firm Name
    GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD
    Operator Number
    10089425
    Address
    Factory No. 6, Lot CN8, Thach That - Quoc Oai Industrial Park, Phung Xa Commune, Thach That District, Hanoi Ci
    City
    Hanoi
    State
    Ha Noi
    Postal Code
    13100
    Country
    VN
    Correspondent
    YAN NONG

    US Agent

    Business Name
    IHEALTH LABS, INC
    Contact Name
    Yange Wang
    Address
    880 W MAUDE AVE,SUNNYVALE , CALIFORNIA , 94085 , UNITED STATES
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US
    Email
    [email protected]
    Phone
    408 6638349

    Products

    Device Name Product Code
    Otoscope ERA

    Proprietary Names

    Smart Otoscope Ear, Nose&Throat HD Camera (Model: 70676-TY) Smart Otoscope Jr. Ear, Nose&Throat HD Camera (Model: 70670-TY) Visual Earpick (Model: CT01)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)