Data / Medical devices / China / Gcmedica Enterprise Ltd. (wuxi)

Gcmedica Enterprise Ltd. (wuxi): FDA-registered device maker in Wuxi Jiangsu, China, 1 510(k) clearance

Name: Gcmedica Enterprise Ltd. (wuxi) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gcmedica Enterprise Ltd. (wuxi) is registered with the FDA (registration 3007681502) in Wuxi Jiangsu, China. It lists 26 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 2, 2019. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007681502
Address: Loujin Industrial Park,Shuofang, Wuxi Jiangsu, China, 214143
Owner or operator: GCMEDICA ENTERPRISE LTD. (WUXI) (10028756)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: March 3, 2009
Registered through: 2026
Brand names listed: Aspiration Tubing Set, BOUGIE, CAT - CANNULA, NASAL, OXYGEN, Ear Syringe, HOLDER, I.V FLUID TRANSFER, Light handle cover, Male Urinal and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Oropharyngeal, Anesthesiology	CAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bath, Sitz, Nonpowered	KTC	1	Contract manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Contract manufacturer	accessdata.fda.gov
Bougie, Eustachian	KBI	1	Contract manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Contract manufacturer	accessdata.fda.gov
Container, Sharps	MMK	2	Contract manufacturer	accessdata.fda.gov
Curette, Uterine	HCY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hematocrit, Tube, Rack, Sealer, Holder	GHY	2	Contract manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Contract manufacturer	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Contract manufacturer	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Contract manufacturer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Snare, Surgical	GAE	1	Contract manufacturer	accessdata.fda.gov
Syringe, Ent	KCP	1	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Contract manufacturer	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Contract manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Contract manufacturer	accessdata.fda.gov
Urinal	FNP	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
December 2, 2019	K182819	Decanting Device	LHI	Substantially Equivalent	Gcmedica Enterprise Ltd.(Wuxi)	accessdata.fda.gov

Compare with other makers

Updated December 2, 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.