Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021349683

FEI Number

3021349683

Entity Name

CHANGZHOU ENDOCLEAN MEDICAL DEVICE CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

West Side of 4th Floor, Building E2 West Taihu Medical Industry, Incubator Park No. 9 Changyang Road Wujin District, Changzhou Jiangsu 213000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Endoclean Medical Device Co., Ltd. (Owner Number: 10083616)

Owner / Operator Contact Address

West Side of 4th Floor, Building E2 West Taihu Medical Industry, Incubator Park No. 9 Changyang Road Wujin District, Changzhou, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endoscopy Kit Cleaning Sponge Disposable Endoscope Valves System Endoscope channel accessory Disposable Endoscope Valves System Endoscope Channel Accessory Adaptor, bulbs, miscellaneous, for endoscope Distal Tip Protector Endoscopy Kit Lubricating Jelly Bowl

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2023-05-08
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2021-12-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-04-12
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2021-12-06
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2023-12-07
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2022-09-20
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-10-12
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-05-08
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2021-12-06
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2023-04-13
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2023-04-13

Official Correspondent

Wang Qi

US Agent Details

Qihui Zhang Business: ZYPPEL LLC Email: Qzhang@Zyppel.Com Phone: (617) 2991655

Related Public Records

Same Entity

Changzhou Endoclean Medical Device 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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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1047429	AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305	TOANO, VA, US
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
3033589330	Merit Medical Australia Pty Ltd.	Braiside Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021349683. Last updated year: 2026. Please use registration number 3021349683 when referencing this establishment in official correspondence.