Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.

Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. specializes in three primary device categories: single-use flexible endoscopic biopsy forceps for obtaining tissue samples during endoscopic procedures, non-bioabsorbable skin staplers designed for wound closure, and single-use surgical suction system collection containers used to manage fluids during surgeries. These devices are developed to meet specific clinical needs in minimally invasive and surgical settings.

The company operates from the United States. While the name may suggest an international focus, its manufacturing and operational headquarters are located within the US, where it develops and distributes its medical devices.

The devices produced by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each device type, including flexible endoscopic biopsy forceps, skin staplers, and surgical suction collection containers, by assigning a unique identifier for tracking purposes.

The company’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices like some surgical instruments, while Class II devices, though still low to moderate risk, require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and clinical context, such as the use of biopsy forceps in endoscopic procedures or skin staplers for wound closure.