Expanding Our Expertise with Another Certification

The EU Medical Device Regulation (MDR) (2017/745) has replaced the existing Medical Device Directive (93/42/EEC) with the goal of enhancing clinical safety and establishing a more transparent, sustainable, and internationally recognized regulatory framework.

At Burgeon, we are proud to announce that our calcium hydroxyapatite-based dermal filler, Novuma, has successfully obtained the MDR 2017/745 (Class III, MDR Annex XVI) certification, making us one of the select companies in Europe to achieve this milestone!

This certification is not just a regulatory approval, but a testament to Burgeon’s commitment to quality, safety, and innovation. With Novuma, we have once again demonstrated our compliance with the highest industry standards, ensuring safe and effective solutions for our customers.

We will continue to push boundaries and bring innovation to the industry!