Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.

The company specialises in single-use bipolar electrosurgical handpieces that include integrated electrodes, primarily designed for open-surgery applications. Additionally, it produces a multi-purpose surgical power tool system and operating racks tailored for surgical environments. These devices are intended to assist in precise tissue manipulation and energy-based surgical procedures.

The company is headquartered in China, as indicated in its regulatory documentation. This location is relevant for understanding its operational base and potential regulatory pathways for its devices.

The company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing is required for transparency and traceability of devices marketed within the EU, ensuring compliance with regulatory requirements.

The company’s devices fall under Class I, Class IIa, and Class IIb classifications in the EU. Classification is determined by factors like the device’s intended use, risk level, and interaction with the body. For example, single-use bipolar electrosurgical handpieces with electrodes are typically classified as higher-risk (Class IIa or IIb) due to their energy-based function and surgical application, while operating racks may qualify as Class I due to lower risk.