Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010612620

FEI Number

3010612620

Entity Name

CHANGZHOU INTL. TRADE & ENTERPRISES COOPERATIVE CO., LTD.

City/State/Country

changzhou Jiangsu, CN

Establishment Address

No.20 Floor, Huajing Building, No.1 Hejing Garden, Zhonglou District, changzhou Jiangsu 213000, CN

Establishment Type(s)

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

Owner / Operator

Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. (Owner Number: 10059339)

Owner / Operator Contact Address

No.20 Floor, Huajing Building, No.1 Hejing Garden, Zhonglou 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

Sterile disposable skin stapler Disposable Specimen Retrieval Bag Disposable Grasping Forceps Disposable Biopsy Forceps, Disposable Rotatable Biopsy Forceps Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing Air/Water Channel Cleaning Adapter, Suction Cleaning Adapter Disposable Bite Blocks Skin Staple Removers Dilators

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2022-04-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-11-01
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2022-10-30
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2022-10-30
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2022-10-30
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-10-30
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-10-30
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2022-10-30
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-11-22
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2022-10-30

Official Correspondent

Chao Huang

US Agent Details

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

Related Public Records

Same Entity

Changzhou Intl. Trade & Enterprises Cooperative 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

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1320894	CONMED CORPORATION	Utica, NY, US
3009221094	PYMDS TECHNOLOGY CORPORATION	WuGu Taipei, TW
3030511423	ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010612620. Last updated year: 2026. Please use registration number 3010612620 when referencing this establishment in official correspondence.