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Data / Medical devices / China / Wellmien Healthcare Tech.(suzhou) Co., Ltd.

Wellmien Healthcare Tech.(suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 4 510(k) clearances

Wellmien Healthcare Tech.(suzhou) Co., Ltd. is registered with the FDA (registration 3014819517) in Suzhou Jiangsu, China. It lists 22 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 6, 2019. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Wellmien Healthcare Tech.(suzhou) Co., Ltd.
FDA registration number
3014819517
Address
1-3603, Global 188, NO.88 Suhui Road, Suzhou Industrial Park, Suzhou Jiangsu, China, 215000
Owner or operator
Wellmien Healthcare Tech.(Suzhou) Co., Ltd. (10080621)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
February 15, 2021
Registered through
2026
Brand names listed
Apron, CPE Gowns, Disposable pillow, Reusable pillow, Non-woven pillow, Disposable Bed pillow, Disposable hygienic pillows, Examination Gowns, Eye Pad, Face Mask, Face Shield, Gauze / sponge and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Apron, ProtectiveIWO1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Exporter to the USaccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNExporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the US, Specification developeraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)NTX1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pad, EyeHMP1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Shield, Protective, PersonnelKPY1Exporter to the USaccessdata.fda.gov
Syringe, AntistickMEG2Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 6, 2019K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseMEGSubstantially EquivalentJiangsu Micsafe Medical Technology Co., Ltd.accessdata.fda.gov
November 15, 2017K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy DrugsLZASubstantially EquivalentZhonghong Pulin Medical Products Co., Ltd.accessdata.fda.gov
March 9, 2016K152712Nitrile Powder Free Patient Examination Gloves, Blue ColorLZASubstantially EquivalentZhonghong Pulin Medical Products Co., Ltd.accessdata.fda.gov
August 9, 2010K101000WELLMIEN SURGICAL MASKFXXSubstantially EquivalentWellmien (Suzhou) Import & Export Trading Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 6, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.