Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004472854

FEI Number

3004472854

Entity Name

JIANGSU KANGJIN MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.56,ChangzhengRd.,ZhengluTown, Changzhou Jiangsu 213111, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Jiangsu Kangjin Medical Instrument Co.,Ltd. (Owner Number: 10061487)

Owner / Operator Contact Address

No.56,ChangzhengRd.,ZhengluTown, Changzhou, CN-JS 213111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE (cleaning brushes ) Disposable Spray Catheters enema bag set disposable mouth guard Disposable distal tip protector for endoscope vaginal speculum disposable catheter, Irrigation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-10-23
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2019-10-23
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2019-10-23
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2019-10-23
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-10-23
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2019-10-23
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2019-10-23

Official Correspondent

Jianqin Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jiangsu Kangjin 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
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004472854. Last updated year: 2026. Please use registration number 3004472854 when referencing this establishment in official correspondence.