Zhejiang Feiman Medical Technology Co., Ltd.

Zhejiang Feiman Medical Technology Co., Ltd. specializes in electrohydraulic universal operating tables. These devices are engineered for surgical environments, offering adjustable patient positioning and hydraulic control to enhance precision and comfort during procedures. The focus is on supporting clinical workflows in operating rooms.

The company is based in the US, which means its devices must comply with U.S. regulatory standards. Since its products are classified as Class I medical devices, they are subject to general controls under FDA regulations, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and transparency in the healthcare supply chain.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and identifying medical devices in the U.S. market, ensuring compliance with FDA requirements for Class I devices, which typically require UDI labeling to facilitate monitoring and recall management.

The devices manufactured by Zhejiang Feiman Medical Technology Co., Ltd. fall under Class I classification in the U.S. regulatory framework. This classification is assigned based on the risk profile of the product—operating tables like these are considered low-risk, requiring only general controls (such as good manufacturing practices and UDI labeling) rather than pre-market approval or post-market surveillance beyond standard compliance.