BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable Medical Face Mask (M643BE)

    Reg #: 9614598 · FEI: 3003191210 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dongguan Sure On Plastic and Fiber Product Co., Ltd.
    Registration Number
    9614598
    FEI Number
    3003191210
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BLDG. 2, CHU FO LING, 168 INDUSTRIAL AREA, TANG XIA
    City
    DONG GUAN CITY Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240258

    Owner / Operator

    Firm Name
    Makrite Industries Inc.
    Operator Number
    8043227
    Address
    11F-5., No.79, Sec.1, Xintai 5th Rd., Xizhi Dist.,
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    221
    Country
    TW
    Correspondent
    Cynthia Shih

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    Disposable Medical Face Mask (M643BE)

    Establishment Types

    Manufacture Medical Device