BEUDAMED
    FDA Registration Active 🇨🇳 China

    WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.

    Reg #: 3014819517 · FEI: 3014819517 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    25
    Establishment Types
    4
    Classifications
    22

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    Registration Details

    Registration Name
    WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.
    Registration Number
    3014819517
    FEI Number
    3014819517
    Status
    Active
    Expiry Year
    2026
    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
    K171873

    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
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Pad, Eye HMP
    Gown, Examination FME
    Apron, Protective IWO
    Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) NTX
    Bedding, Disposable, Medical KME
    Shield, Protective, Personnel KPY
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC
    Fiber, Medical, Absorbent FRL
    Gauze / Sponge,Nonresorbable For External Use NAB
    Accessory, Surgical Apparel LYU
    Mask, Surgical FXX
    Disinfectant, Medical Devices LRJ
    Tape And Bandage, Adhesive KGX
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Antistick MEG
    Cap, Surgical FYF
    Cover, Shoe, Operating-Room FXP
    Non-Surgical Gown OEA

    Proprietary Names

    Face Mask Eye Pad Examination Gowns Apron Nursing Pad Medical Bedding and Blanket Disposable pillow, Reusable pillow, Non-woven pillow, Disposable Bed pillow, Disposable hygienic pillows Face Shield Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs Non woven ball(without x-ray detectable) absorbent pads OR Towel, Operation Towel Non woven swab/Non woven pad (without x-ray detectable) Surgical operation towel(without x-ray detectable) Gauze / sponge Oversleeves Nitrile Powder Free Patient Examination Gloves, Blue Color Surgical Mask Pad, Alcohol, Device Disinfectant Tape and bandage, adhesive Goggles, safety goggles, eye shield Syringe with Needle Surgical Cap Shoe Cover CPE Gowns

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility