BEUDAMED
    FDA Registration Active 🇨🇳 China

    WINNER MEDICAL CO., LTD.

    Reg #: 9616433 · FEI: 3005076849 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    WINNER MEDICAL CO., LTD.
    Registration Number
    9616433
    FEI Number
    3005076849
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Winner Industrial Park, No. 660 Bulong Road, Longhua District
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K023755

    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
    Correspondent
    Xiaomeng Yang

    US Agent

    Business Name
    REGISTRAR CORP
    Contact Name
    DAVID LENNARZ
    Address
    144 Research Dr, Hampton, VA US 23666 , UNITED STATES
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Pad, Alcohol, Device Disinfectant LKB
    Dressing, Wound, Hydrophilic NAC
    Hearing Aid, Air-Conduction, Over The Counter QUF
    Mask, Surgical FXX
    Dressing, Wound, Occlusive NAD

    Proprietary Names

    alcohol device disinfectant Super Absorbent Dressing Alginate Dressing Nonwoven Adhesive wound dressing (Strip) CMC Gelling Fiber Dressing Wound Dressing ALMORIS Alginate Wound Dressing Activated Charcoal Super Absorbent Dressing Silicone Super Absorbent Dressing transparent dressing Silicone Absorbent Soft Dressing with border HidraWear Superabsorbent Dressing Calcium Alginate Wound Dressing Hearing Aid Transparent Dressing Sacrum Silicone Foam Dressing with Border Silicone Contact Layer Transparent Film Dressing Foam Dressing Silicone Foam Dressing Hydrocolloid Dressing Silicone Foam Dressing with Border ALMORIS Silicone Foam Dressing Foam dressing without border Silicone Foam Dressing without Border Dimora HEEL FOAM DRESSING Without Borde HidraWear Foam Dressing Hydrocolloid (Sterile Wound Dressing with Border) Waterproof Foam Dressing Hydrocolloid Roll

    Establishment Types

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