UNI-TREND TECHNOLOGY (CHINA) CO., LTD.

UNI-TREND manufactures infrared thermometers that measure body temperature through the ear or skin. Their portfolio includes both contact-based ear/skin thermometers and non-contact forehead thermometers, such as the UT30H, UT306H, and UT308H series. These devices rely on infrared technology to provide rapid temperature readings, commonly used in clinical and home settings.

UNI-TREND is based in the US, though its manufacturing origins are in China. Their devices fall under Class II classification, which means they are subject to stricter regulatory oversight compared to Class I devices. In the US, their products are listed under the FDA’s 510(k) clearance pathway and comply with UDI (Unique Device Identification) requirements, ensuring traceability and compliance with safety standards.

UNI-TREND’s devices are included in the FDA’s 510(k) clearance registry and the FDA’s UDI (Unique Device Identification) database. These registries track compliance, clearance status, and device identification to ensure transparency and adherence to US medical device regulations.

UNI-TREND’s infrared thermometers are classified as Class II medical devices in the US. This classification is determined by their intended use—measuring body temperature—and their associated risk level. Class II devices require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet safety and performance standards before commercial distribution.