Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016884191

FEI Number

3016884191

Entity Name

JIANGSU RONGYE TECHNOLOGY CO.,LTD

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

Touqiao Town, Yangzhou City, Jiangsu, P.R. China, Yangzhou Jiangsu 225109, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Rongye Technology Co.,Ltd (Owner Number: 10070223)

Owner / Operator Contact Address

Touqiao Town, Yangzhou City, Jiangsu, P.R. China, Yangzhou, CN-JS 225109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Speculum Blood Collection Tube, Vacuum Tube Centrifuge tube; ESR tube blood collection needle Medical suction collecting tubes for single use,Medical suction collecting tubes with Yankauer Handle Medical suction collecting tubes for single use,Medical suction collecting tubes with Yankauer Handle face mask forceps Urine bag sampling collection kit, disposable viral transport tube, disposable viral collection tube Urine bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2024-03-11
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2025-06-30
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	2025-06-30
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-06-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-06-30
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-01-16
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-01-16
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-16
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-06-30
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-03-11
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-04-16
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-03-11

Official Correspondent

yue Jiang

US Agent Details

Chris Nagle Email: Cnagle@woodsideacquisitions.com Phone: (814) 2182804

Related Public Records

Same Entity

Jiangsu Rongye Technology Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016884191. Last updated year: 2026. Please use registration number 3016884191 when referencing this establishment in official correspondence.