Suzhou Xixin Medical Instruments Co., Ltd.

Suzhou Xixin Medical Instruments Co., Ltd. specializes in electromechanical lithotripsy systems, specifically extracorporeal shock wave lithotripters. These devices are designed to non-invasively break up kidney or urinary tract stones using controlled shock waves, helping patients avoid surgical interventions for stone removal.

The company is based in the United States. While the name suggests a Chinese origin, the operational headquarters and regulatory presence are established within the US market.

The extracorporeal shock wave lithotripters produced by Suzhou Xixin Medical Instruments Co., Ltd. fall under Class II classification. This classification typically indicates moderate risk, requiring special controls to ensure safety and effectiveness beyond general controls, though individual devices must still undergo their own regulatory authorization process.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify and verify specific devices.