Focus&Fusion Healthcare (Hangzhou) Co., Ltd

Focus&Fusion Healthcare (Hangzhou) Co., Ltd specializes in hand-held extracorporeal ultrasound imaging transducers (commonly known as ultrasound probes) and ultrasound scanners. These devices are designed for diagnostic imaging, monitoring, and screening applications, leveraging ultrasound technology to visualize internal body structures for medical evaluation.

The company is headquartered in China, specifically in Hangzhou. Its geographic location supports its focus on developing and manufacturing ultrasound-based medical devices tailored for global diagnostic and monitoring needs.

The devices produced by Focus&Fusion Healthcare (Hangzhou) Co., Ltd are listed in the EU’s eudamed registry, which is the official database for medical devices authorized within the European Union. This registry helps ensure transparency and traceability of devices classified under EU regulations.

The company’s devices fall under Class IIa classification, which is the second-lowest risk category in the EU’s medical device hierarchy. This classification applies to devices that pose minimal risk but still require compliance with specific design controls, performance standards, and post-market surveillance to ensure safety and efficacy for diagnostic and monitoring purposes.