BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate

    Reg #: 3038592309 · FEI: 3038592309 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    VIETWELL TECHNOLOGY VIETNAM CO., LTD.
    Registration Number
    3038592309
    FEI Number
    3038592309
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT CN16 Bim Son A Industrial Park
    City
    Bim Son Thanh Hoa
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K243792

    Owner / Operator

    Firm Name
    VietWell Technology Vietnam Co., Ltd.
    Operator Number
    10093305
    Address
    LOT CN16 Bim Son A Industrial Park
    City
    Bim Son
    State
    Thanh Hoa
    Postal Code
    40700
    Country
    VN
    Correspondent
    Tram MAI Thi

    US Agent

    Business Name
    Primemax
    Contact Name
    Max Lee
    Address
    805 BARRINGTON AVE.
    City
    Ontario
    State
    CA
    ZIP
    91764
    Country
    US
    Email
    [email protected]
    Phone
    909 9801678

    Products

    Device Name Product Code
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device