Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006750742

FEI Number

3006750742

Entity Name

CHANGZHOU JIUHONG MEDICAL INSTRUMENT CO., LTD.

City/State/Country

CHANGZHOU Jiangsu, CN

Establishment Address

1F,4F,Ruili Building,No.2-1,Changyang Road, Wujin Economic Development Zone, CHANGZHOU Jiangsu 213145, CN

Establishment Type(s)

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

Owner / Operator

Changzhou Jiuhong Medical Instrument Co., Ltd. (Owner Number: 9104401)

Owner / Operator Contact Address

1F,4F,Ruili Building,No.2-1,Changyang Road, Wujin Economic Development Zone, Changzhou, CN-JS 213145, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sclerotherapy & Endoscopic Needles Non-vascular Guidewires Cleaning Brushes for Endoscope Forceps, Biopsy, Non-Electric Polyp Traps Dilation Balloons Bougie Dilator Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-05-08
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-10-18
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-06-25
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2007-07-13
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2014-06-25
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2019-10-18
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2019-10-18

Official Correspondent

Lin Zhang

US Agent Details

Charles MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Changzhou Jiuhong Medical Instrument 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
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006750742. Last updated year: 2026. Please use registration number 3006750742 when referencing this establishment in official correspondence.