Data / Medical devices / China / Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.

Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.: FDA-registered device maker in changzhou Jiangsu, China, 4 510(k) clearances

Name: Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. is registered with the FDA (registration 3010612620) in changzhou Jiangsu, China. It lists 14 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 29, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010612620
Address: No.20 Floor, Huajing Building, No.1 Hejing Garden, Zhonglou District, changzhou Jiangsu, China, 213000
Owner or operator: Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. (10059339)
Roles: Exporter to the US, Manufacturer
First device listed: November 1, 2020
Registered through: 2026
Brand names listed: Air/Water Channel Cleaning Adapter, Suction Cleaning Adapter, Cleaning Brushes for Endoscope, Dilators, Disposable Biopsy Forceps, Disposable Rotatable Biopsy Forceps, Disposable Bite Blocks, Disposable Endoscope Valves System, Disposable Grasping Forceps, Disposable Specimen Retrieval Bag and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	FAT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Exporter to the US	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Exporter to the US	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For Endoscope	FCX	2	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Stapler, Skin	QQS	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 29, 2023	K232244	Disposable Endoscope Valves System	ODC	Substantially Equivalent	Changzhou Endoclean Medical Device Co., Ltd.	accessdata.fda.gov
October 7, 2022	K221310	Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing	OCX	Substantially Equivalent	Changzhou Endoclean Medical Device Co., Ltd.	accessdata.fda.gov
September 8, 2022	K221331	Disposable Endoscope Valves System	ODC	Substantially Equivalent	Changzhou Endoclean Medical Device Co., Ltd.	accessdata.fda.gov
April 21, 2020	K200053	DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)	GCJ	Substantially Equivalent	Dannik	accessdata.fda.gov

Compare with other makers

Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.