BEUDAMED
    FDA Registration Active 🇨🇳 China

    Sterilux AMD Sterile Bulky Antimicrobial Gauze

    Reg #: 3030067857 · FEI: 3030067857 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WINNER MEDICAL CO., LTD.
    Registration Number
    3030067857
    FEI Number
    3030067857
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street, Longhua District
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181315

    Owner / Operator

    Firm Name
    WINNER MEDICAL CO., LTD.
    Operator Number
    9012349
    Address
    42nd Floor, Building No.2, Huilong Business Center, Longhua District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518109
    Country
    CN

    US Agent

    Business Name
    Registrar Corp.
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    Sterilux AMD Sterile Bulky Antimicrobial Gauze Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-Woven Sponge Dressing Antimicrobial Super Sponge Dressing, 4.5''X4.1YDS-6P, EO Antimicrobial Super Sponge Dressing 32/12X5,6X6"-12P,2S,EO

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility