BEUDAMED
    FDA Registration Active 🇨🇳 China

    XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD

    Reg #: 3012268821 · FEI: 3012268821 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    11

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    Registration Details

    Registration Name
    XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD
    Registration Number
    3012268821
    FEI Number
    3012268821
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    North of the National Road 318, Dongjiazui Village,Huchang Town
    City
    xiantao Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221977

    Owner / Operator

    Firm Name
    Xiantao Topmed Nonwoven Protective Products Co., Ltd
    Operator Number
    10081073
    Address
    North of the National Road 318, Dongjiazui Village,Huchang Town
    City
    xiantao
    State
    Hubei
    Postal Code
    433000
    Country
    CN
    Correspondent
    RONG ZHU

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Bedding, Disposable, Medical KME
    Suit, Surgical FXO
    Gauze / Sponge,Nonresorbable For External Use NAB
    Gown, Surgical FYA
    Cover, Shoe, Operating-Room FXP
    Cap, Surgical FYF
    Absorber, Saliva, Paper KHR
    Garment, Protective, For Incontinence EYQ
    Pad, Menstrual, Unscented HHD
    Non-Surgical Gown OEA
    Mask, Surgical FXX

    Proprietary Names

    Disposable pillow case, Disposable blanket BED SHEET, BED COVER, BED SHEET ROLL,DENTAL SHEET Nonwoven gauze Disposable Surgical Gown (G4003) BOOT COVER, DISPOSABLE SLIPPER,SLEEVE COVER, SHOE COVER CAP/DISPOSABLE CAP/NONWOVEN CAP/MOB CAP CLIP CAP/ROUND CAP,NURSE CAP,BALACLAVE CAP, SURGICAL CAP Dental bib Diaper Underpad CPE GOWN,ISOLAITON GOWN, PE RAIN COAT GOWN,APRON,LAB COAT, PATIENT GOWN,SCRUB SUIT Disposable Medical Face Mask (ear loop)

    Establishment Types

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