BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    KI. WORKS VIETNAM CO., LTD.

    Reg #: 3006789197 · FEI: 3006789197 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KI. WORKS VIETNAM CO., LTD.
    Registration Number
    3006789197
    FEI Number
    3006789197
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    40 DAI LO DOC LAP, VIETNAM SINGAPORE INDUSTRIAL PARK
    City
    THUAN AN DISTRICT Binh Duong
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K123849

    Owner / Operator

    Firm Name
    KI. WORKS VIETNAM CO., LTD.
    Operator Number
    9090960
    Address
    40 DAI LO DOC LAP, VIETNAM, SINGAPORE INDUSTRIAL PARK
    City
    THUAN AN DT BINH DUONG PROVINC
    State
    VN-NOTA
    Postal Code
    --
    Country
    VN
    Correspondent
    CHIU-LIN - HUANG

    US Agent

    Business Name
    Compliance Engineering, Inc.
    Contact Name
    Ken Grant
    Address
    2611 Merrick Rd #66
    City
    Bellmore
    State
    NY
    ZIP
    11710
    Country
    US
    Email
    [email protected]
    Phone
    516 9847287

    Products

    Device Name Product Code
    Mouthguard, Over-The-Counter OBR

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)