BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hypodermic Needle

    Reg #: 3010147274 · FEI: 3010147274 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shanghai Hua En Industrial Co Ltd
    Registration Number
    3010147274
    FEI Number
    3010147274
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #30, NO988 HUI JI ROAD, XUANQIAO, TOWN, PUDONG
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K152824

    Owner / Operator

    Firm Name
    SHANGHAI HUA EN INDUSTRIAL CO LTD
    Operator Number
    10043241
    Address
    #30,NO988 HUI JI ROAD, XUANQIAO TOWN, PUDONG
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201314
    Country
    CN
    Correspondent
    Lisa Zhao

    US Agent

    Business Name
    UG HEALTHCARE
    Contact Name
    Patrick Stanton
    Address
    1565 Sunflower Avenue
    City
    Costa Mesa
    State
    CA
    ZIP
    92626
    Country
    US
    Email
    [email protected]
    Phone
    800 3287981

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Hypodermic Needle

    Establishment Types

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