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Jiangsu Rongye Technology Co.,ltd: FDA-registered device maker in Yangzhou Jiangsu, China, 1 510(k) clearance

Name: Jiangsu Rongye Technology Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jiangsu Rongye Technology Co.,ltd is registered with the FDA (registration 3016884191) in Yangzhou Jiangsu, China. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016884191
Address: Touqiao Town, Yangzhou City, Jiangsu, P.R. China, Yangzhou Jiangsu, China, 225109
Owner or operator: Jiangsu Rongye Technology Co.,Ltd (10070223)
Roles: Manufacturer
First device listed: April 16, 2020
Registered through: 2026
Brand names listed: Blood Collection Tube, Vacuum Tube, Centrifuge tube; ESR tube, Culture Swab, Stuart medium, Amies medium, Cary Blair medium, Medical suction collecting tubes for single use,Medical suction collecting tubes with Yankauer Handle, Nasopharyngeal swabs,dispoable sampling swab, Speculum, Sterile swab,, Urine bag and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-Sterile	NNW	1	Manufacturer	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Manufacturer	accessdata.fda.gov
Transport Medium, Notified Per The Vtm Guidance	QMC	1	Manufacturer	accessdata.fda.gov
Tube, Sedimentation Rate	GHC	1	Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	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
October 27, 2023	K213146	Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen	JKA	Substantially Equivalent	Jiangsu Rongye Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 27, 2023. 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.