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Teoxane Achieves MDR Certification for TEOSYAL® PureSense and TEOSYAL RHA®
Geneva, December 1st, 2023 — Teoxane is the first company to receive the Medical Device Regulation (MDR) certification for its entire product range, including TEOSYAL® PureSense and TEOSYAL RHA®.
Geneva, December 1st, 2023 — Teoxane is the first company to receive the Medical Device Regulation (MDR) certification for its entire product range, including TEOSYAL® PureSense and TEOSYAL RHA®. This CE certification reinforces Teoxane's unwavering commitment to safety and quality in hyaluronic acid-based wrinkle treatments. Introduced in May 2017 and effective since May 2021, MDR imposes stringent requirements for efficacy, quality and safety assessments. Teoxane's compliance is evident through 14 clinical studies conducted in Europe and the United States, showcasing the notable clinical performance of its products. The certification underscores Teoxane's dedication to robust standards in product design, production, and post-market monitoring.
In 2017, Teoxane achieved a significant milestone by securing FDA approval for its RHA® range, marking a pivotal moment in the company's journey. The approval coupled with the recent MDR certification, stands as a testament to Teoxane’ s expertise in the science of facial aesthetics and solidifies Teoxane's position in the industry, dedicated to providing cutting-edge solutions for wrinkle correction.
"Receiving this approval is a source of great pride for us and a testament to our commitment to safety and clinical excellence, which are central to our product design. At Teoxane, our ambition goes beyond mere compliance with standards. We aspire to be pioneers, anticipating regulatory implementation and innovating with solutions that will raise standards in our industry, for the benefit of patients." - Valérie Taupin, CEO and Founder of Teoxane