Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016685983

FEI Number

3016685983

Entity Name

JIANGSU HONGXIN MEDICAL TECHNOLOGY CO, LTD.

City/State/Country

Shuyang City Jiangsu, CN

Establishment Address

East Side of Jinhua Road, Shuyang City Jiangsu None, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Hongxin Medical Technology Co, Ltd. (Owner Number: 10064475)

Owner / Operator Contact Address

East Side of Jinhua Road, Shuyang City, CN-JS None, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2024-12-30
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2021-05-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-25
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Jiangsu Hongxin Medical 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Similar Registrations

Registration Number	Establishment Name	Location
3016758972	ANJI SPENQ INDUSTRIAL CO., LTD.	Huzhou Zhejiang, CN
3010339057	SUZHOU TEXNET	Suzhou Jiangsu, CN
9611590	PRODUCTOS PARA EL CUIDADO DE LA SALUD	NOGALES Sonora, MX
1423537	Cardinal Health 200, LLC	Waukegan, IL, US
3011707784	CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016685983. Last updated year: 2026. Please use registration number 3016685983 when referencing this establishment in official correspondence.