"Sunvou Secures Milestone with Class II Certification for Revolutionary Oral Gas Sampling Device"

Sunvou Medical has reached a significant milestone with the successful acquisition of a Class II medical device registration certificate (No. 20242220078) for its innovative CA3138 oral gas sampling device. This achievement reflects the company’s continued commitment to advancing diagnostic technologies and expanding its portfolio of clinically valuable solutions.

The newly certified CA3138 device is designed to address a long-standing challenge in respiratory and oral diagnostics: accurately distinguishing between gases originating from the oral cavity and those from non-oral sources. By applying advanced three-dimensional simulations of gas fluid mechanics and mass transfer dynamics, Sunvou’s research and development team has created a highly precise sampling system. The device can be conveniently positioned under or on the tongue, enabling effective and controlled gas collection tailored to specific diagnostic needs.

One of the key strengths of the CA3138 lies in its ability to regulate gas collection parameters such as pressure, flow direction, and composition. This ensures that clinicians can selectively capture either oral or non-oral gases with high accuracy. When integrated with Sunvou’s multi-molecular breath analyzer, the system allows for clear differentiation in the concentration of critical biomarkers, including nitric oxide, hydrogen sulfide, hydrogen, and methane.

This technological advancement opens new possibilities for the precise identification and evaluation of both oral and systemic conditions. By enabling clearer separation of gas sources, the device enhances diagnostic reliability and supports more targeted clinical decision-making.

The certification of the CA3138 not only underscores Sunvou Medical’s innovation capabilities but also marks an important step forward in the evolution of breath-based diagnostics. As the demand for non-invasive, accurate, and efficient diagnostic tools continues to grow, this breakthrough reinforces Sunvou’s position as a leader in next-generation medical technology.