BEUDAMED
    FDA Registration Active 🇨🇳 China

    Surgical Mask

    Reg #: 3014819517 · FEI: 3014819517 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.
    Registration Number
    3014819517
    FEI Number
    3014819517
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-3603, Global 188, NO.88 Suhui Road, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K101000

    Owner / Operator

    Firm Name
    Wellmien Healthcare Tech.(Suzhou) Co., Ltd.
    Operator Number
    10080621
    Address
    1-3603, Global 188, NO.88 Suhui Road, Suzhou Industrial Park
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215000
    Country
    CN
    Correspondent
    Charles Shen

    US Agent

    Business Name
    Manton Business and Technology Services
    Contact Name
    Charles Shen
    Address
    37 Winding Ridge
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    608 2179358

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    Surgical Mask

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility