Ventilation manufacturer Telesair clinches CE Mark for Bonhawa HFOT System

Telesair, Inc., a vanguard in advanced respiratory technology, has clinched the coveted CE (Conformité Européenne) Marking, a monumental accomplishment under the rigorous European Medical Device Regulation, for its cutting-edge Bonhawa High Flow Oxygen Therapy (HFOT) system. This pivotal approval paves the way for its use in treating patients grappling with respiratory insufficiency.

Securing the CE Mark under the stringent European Medical Device Regulation (EC/MDR) is an accolade not many achieve, particularly noteworthy as the Bonhawa HFOT is among the initial US-based respiratory therapeutic devices to attain this recognition.

Bonhawa’s hallmark HFOT system, distinguished by its lightweight design, offers an impressive flow range of up to 80 L/pm, complemented by its effortless disinfection process and user-friendly touchscreen. These features not only promise a more expansive therapeutic spectrum and efficient sanitization but also facilitate caregivers by diminishing their workload and enabling an external room view of patient settings and pertinent data.

Reflecting on this landmark achievement, Telesair’s CEO, Bryan Liu, proclaimed, “The European approval of our Bonhawa system marks a seminal juncture for Telesair.” He attributed this rapid success – realized in under 10 months – to their stellar team, groundbreaking respiratory tech products, meticulous attention to detail, and unmatched value. Liu also teased their focus on swiftly attaining approval for their impending next-gen home-based platform.

Telesair’s triumphant acquisition of the CE Mark and the subsequent European debut of its state-of-the-art oxygen therapy system amplifies the firm’s market outreach, which already encompasses Latin America and Southeast Asia.