Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016616327

FEI Number

3016616327

Entity Name

ZHANGJIAGANG SHENGANG MEDICAL PRODUCTS CO.,LTD

City/State/Country

Zhangjiagang Jiangsu, CN

Establishment Address

No.388 Yongjin Road,, Tangqiao Town, Zhangjiagang Jiangsu 215615, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Zhangjiagang Shengang Medical Products Co.,Ltd (Owner Number: 10063070)

Owner / Operator Contact Address

Xican North Road, Xican Village, Fenghuang Town, Zhangjiagang, CN-NOTA 215614, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2022-03-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-03-07
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-06-24
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-16
FMC	Patient Examination Glove	General Hospital	Class 1	880.6250	2021-03-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-23

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

Zhangjiagang Shengang Medical Products 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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

Similar Registrations

Registration Number	Establishment Name	Location
1018233	C.R. BARD, INC.	COVINGTON, GA, US
3012445205	AMSINO MEDICAL GROUP (HK) COMPANY LIMITED	HONG KONG, HK
9680890	RIBBEL INTERNATIONAL LTD.	SONEPAT Haryana, IN
3006082230	C.R. BARD, INC.	MADISON, GA, US
3031582449	JM MEDICAL CO., LTD.	Liaocheng Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016616327. Last updated year: 2026. Please use registration number 3016616327 when referencing this establishment in official correspondence.