Vinno Technology (Suzhou) Co., Ltd

Vinno Technology (Suzhou) Co., Ltd specializes in handheld extracorporeal ultrasound imaging transducers and portable ultrasound diagnostic systems. These devices are designed for real-time medical imaging, enabling clinicians to perform diagnostic procedures in various clinical environments. The focus is on compact, portable solutions for ultrasound-based diagnostics.

The company is headquartered in China, specifically in Suzhou. This location influences its regulatory compliance and manufacturing operations, ensuring alignment with local and international medical device standards.

Vinno Technology’s devices are listed in the EU’s eudamed registry, which tracks medical devices authorized under EU regulations, and the FDA’s 510(k) database, which documents devices cleared for sale in the United States through the 510(k) premarket notification process. These listings reflect compliance with respective regional requirements.

Vinno Technology’s devices fall into Class II and Class IIa classifications. Class II devices typically pose moderate risks and require special controls beyond general controls to ensure safety and effectiveness, while Class IIa devices are generally lower-risk but still require validation of performance and safety. These classifications determine regulatory oversight and compliance requirements.