Qingdao Hisense Medical Equipment Co., Ltd.

Qingdao Hisense Medical Equipment Co., Ltd. specializes in ultrasound-related medical devices. Their portfolio includes handheld extracorporeal ultrasound imaging transducers, general-purpose ultrasound imaging systems, rectal/vaginal ultrasound imaging transducers, and monochrome image display units. These devices are designed for diagnostic imaging applications, particularly in ultrasound technology.

The company is headquartered in Qingdao, China. This location reflects its primary operational base for manufacturing and distributing its medical imaging devices.

The company’s devices are listed in multiple global regulatory databases, including the EU’s eudamed registry and the U.S. FDA’s 510(k) premarket notification system as well as the FDA’s Unique Device Identifier (UDI) database. These registries help track and verify the compliance and availability of their medical devices in different markets.

The devices manufactured by Qingdao Hisense Medical Equipment Co., Ltd. fall under Class I, Class II, and Class IIa regulatory classifications. These classifications determine the level of scrutiny and regulatory oversight required, with Class I being the lowest risk and Class IIa representing moderate risk based on their intended use and potential health impact.