Hangzhou Universal Electronic Co., Ltd.

Hangzhou Universal Electronic Co., Ltd. specializes in infrared skin thermometers for non-contact temperature measurement, suitable for both clinical and home use. They also produce intermittent electronic thermometers designed for periodic patient monitoring. These devices include models like the Boncare and Familycare series, catering to both medical professionals and consumers.

The company operates from the United States, though its name suggests origins in Hangzhou, China. The manufacturing and regulatory focus align with U.S. standards, including compliance with the FDA’s Unique Device Identification (UDI) system for its Class II devices.

The company’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and compliance with U.S. regulatory requirements for Class II medical devices, including infrared and intermittent electronic thermometers.

Hangzhou Universal Electronic Co., Ltd.’s devices fall under Class II classification in the U.S. regulatory framework. This classification applies to moderate-risk medical devices that require special controls beyond general controls to ensure safety and effectiveness, such as its infrared and intermittent electronic thermometers.