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Wuxi Yushou Medical Appliances Co., Ltd: FDA-registered device maker in Wuxi City Jiangsu, China, 7 510(k) clearances

Name: Wuxi Yushou Medical Appliances Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wuxi Yushou Medical Appliances Co., Ltd is registered with the FDA (registration 3003829571) in Wuxi City Jiangsu, China. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 18, 2022. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3003829571
Address: No.115 Nongxinhe Road Dongbeitang, Xishan District, Wuxi City Jiangsu, China, 214191
Owner or operator: WUXI YUSHOU MEDICAL APPLIANCES CO., LTD (9080780)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: May 31, 2007
Registered through: 2027
Brand names listed: Multiple, Piston Syringe, YM70-80

Devices it lists

Device	Product code	Class	Role	Source
Assembly, Tube Housing, X-Ray, Diagnostic	ITY	1	Manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Manufacturer, Specification developer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 18, 2022	K210679	Medical Face Mask	FXX	Substantially Equivalent	Wuxi Yushou Medical Appliances Co., Ltd.	accessdata.fda.gov
November 22, 2016	K152906	Disposable High Pressure Injector Syringe	DXT	Substantially Equivalent	Wuxi Yushou Medical Appliances Co., Ltd.	accessdata.fda.gov
November 20, 2013	K130230	STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES	FMF	Substantially Equivalent	Wuxi Yushou Medical Applicances Co., Ltd.	accessdata.fda.gov
November 20, 2013	K130212	SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE	FMI	Substantially Equivalent	Wuxi Yushou Medical Applicances Co., Ltd.	accessdata.fda.gov
December 23, 2011	K112789	EASY TOUCH	FMI	Substantially Equivalent	Mhc Medical Products, LLC	accessdata.fda.gov
September 2, 2010	K102178	EASY TOUCH	FMF	Substantially Equivalent	Mhc Medical Products	accessdata.fda.gov
August 11, 2006	K053519	SAFETY SYRINGE	MEG	Substantially Equivalent	Wuxi Yushou Medical Applicances Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 18, 2022. 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.