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

The company specializes in endoscopic and surgical instruments, including both single-use and reusable devices. Their portfolio covers a range of products such as tissue morcellation handpieces, disposable Veress needles, stents (esophageal and bronchial), electrosurgical electrodes, stone extraction tools, retrieval bags, dilation catheters, grasping forceps, camera sleeves, and balloon inflators. These devices are designed for procedures in surgical and endoscopic settings.

The company is based in China. While the location helps contextualize its operations, it is important to note that regulatory status and compliance are determined by the individual devices themselves, not the company’s headquarters.

Yes, the company’s devices are listed in the euDaMed database, which is the European Union’s official registry for medical devices. Listing in euDaMed indicates that the devices have undergone the necessary regulatory processes to be marketed in the EU, though it does not imply approval—only that they meet the requirements for registration.

The company’s devices fall into three classification categories under EU regulations: Class I (generally low-risk devices like some surgical instruments), Class IIa (moderate-risk devices such as certain stents or dilation catheters), and Class IIb (higher-risk devices like some endoscopic retrieval tools or electrosurgical electrodes). Classification determines the regulatory scrutiny and compliance requirements each device must meet.