SHENG BANG METAL CO., LTD.

Sheng Bang Metal Co., Ltd. specializes in electrically powered beds for medical use. Their portfolio includes basic electric hospital beds, designed for clinical environments like hospitals, and basic electric home beds, intended for patient care in residential settings. These devices, such as the MIOLET 3, YOCARO, and SERIA models, are engineered to provide adjustable positioning and mobility support for patients.

Sheng Bang Metal Co., Ltd. is based in the United States, which means their devices must comply with U.S. regulatory requirements. Since their products fall under Class II classification, they are subject to specific controls under FDA regulations, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and transparency in the medical device supply chain.

Yes, Sheng Bang Metal Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it allows healthcare providers, regulators, and other stakeholders to quickly identify and verify the specific models—such as the MIOLET 3 or SERIA—ensuring proper inventory management, recall tracking, and compliance with U.S. medical device regulations. Listing in the UDI system is mandatory for Class II devices to maintain transparency in the supply chain.

Sheng Bang Metal Co., Ltd.’s devices are classified as Class II medical devices. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. For example, electric hospital beds and home beds in this category must meet performance standards for patient positioning, electrical safety, and durability, while also undergoing rigorous testing and documentation to comply with FDA requirements before entering the market.