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Data / Medical devices / China / Ucomfor Medical Co., Ltd.

Ucomfor Medical Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances

Ucomfor Medical Co., Ltd. is registered with the FDA (registration 3009104075) in Shanghai, China. It lists 17 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 16, 2010. 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 Ucomfor Medical Co., Ltd.
FDA registration number
3009104075
Address
Rm1208, No.76 Jiuxin Road, Shanghai, 201615, P.R.China, Shanghai, China, 201615
Owner or operator
Ucomfor Medical Co., Ltd. (10038509)
Roles
Exporter to the US
First device listed
October 19, 2011
Registered through
2026
Brand names listed
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, Bulb irrigation syringe 60cc, Enteral irrigation syringe 60cc, EAR BULB SYRINGE, Piston enteral irrigation syringe 60cc, Connector, catheter, Enteral syringe, irrigation syringe, Irrigation syringe,Syringe Ear Ulcer, Leg Bag, SUCTION YANKAUER with/without vent, Suction Tubing, Suction Connection Tubing and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Exporter to the USaccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Exporter to the USaccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Connector, CatheterGCD1Exporter to the USaccessdata.fda.gov
Device, Paste-On For Incontinence, Non-SterileNOA1Exporter to the USaccessdata.fda.gov
Device, Paste-On For Incontinence, SterileEXI1Exporter to the USaccessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, DisposableFFG2Exporter to the USaccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Exporter to the USaccessdata.fda.gov
Excavator, EarJYH1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Respirator, SurgicalMSH2Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Syringe, EntKCP1Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Exporter 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
August 16, 2010K100846IMC SURGICAL FACE MASKFXXSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
July 11, 2005K050887GONGDONG DISPOSABLE VAGINAL SPECULUMHIBSubstantially EquivalentZhejiang Gongdong Medical Plastic Factoryaccessdata.fda.gov

Compare with other makers

Updated August 16, 2010. 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.