Shanghai Microport Ep Medtech Co., Ltd.

Shanghai Microport Ep Medtech Co., Ltd. specializes in single-use cardiac devices. Their portfolio includes cardiac mapping catheters with fixed curve designs, primarily for diagnostic electrophysiological studies, and percutaneous transseptal access sets used to guide interventions across the atrial septum. These devices are tailored for procedures like structural heart interventions.

The company operates from the United States, though its manufacturing may occur in China (Shanghai). The U.S. presence is relevant for regulatory engagement, particularly with the FDA’s UDI system, where their devices are listed.

Yes, the company’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry tracks Class II medical devices authorized for commercial distribution in the U.S., ensuring traceability and compliance with regulatory requirements.

All of the company’s listed devices fall under Class II classification in the U.S. This classification applies to devices that pose moderate risk and require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness without requiring pre-market approval.