Group Supply Organization Medical Technology(Shanghai) Ltd

Group Supply Organization Medical Technology(Shanghai) Ltd produces three primary device types: pneumatic arterial tourniquets (used to control blood flow in surgeries), single-use manual limb tourniquets (for isolating extremities), and irrigation syringes (for precise fluid delivery in medical procedures). These devices support critical functions in surgical and procedural settings, ensuring controlled environments for patient care.

The company is based in the United States. While its name includes 'Shanghai,' the operational headquarters and regulatory presence align with US-based manufacturing and compliance standards for its medical devices.

The company’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This system is mandatory for Class I devices in the US, ensuring traceability and compliance with regulatory requirements. The UDI listing confirms the devices’ authorised status under FDA guidelines.

All devices manufactured by Group Supply Organization Medical Technology(Shanghai) Ltd fall under Class I regulatory classification in the US. Class I devices are generally considered low-risk and typically require compliance with general controls (e.g., proper labeling, manufacturing practices) rather than pre-market approval. The company’s devices meet these requirements through the FDA’s UDI system.

The FDA’s Unique Device Identifier (UDI) system is a mandatory requirement for all medical devices in the US, including Class I products. The UDI ensures devices can be uniquely identified throughout their lifecycle—from manufacturing to patient use—enhancing traceability, reducing medical errors, and supporting post-market surveillance. By listing devices in the UDI database, the company demonstrates compliance with federal identification standards.