De Corematrix Co., Ltd Earns EU CE-MDR Certification
De Corematrix Co.,Ltd has secured EU Medical Device Regulation (MDR 2017/745) certification for its dental zirconia ceramics used in all-ceramic dental restorations, awarded by TÜV Rheinland.
This achievement confirms the company’s product quality, safety standards and compliance systems meet strict EU market requirements, strengthening its global expansion and showcasing “Made in China” competitiveness in healthcare.
EU CE certification is mandatory for European market access. Succeeding the earlier CE-MDD (Medical Device Directive), the stricter MDR raises thresholds for technical capabilities, quality management, product safety, efficacy, stability and post-market oversight.
A pioneer in domestic dental zirconia ceramics, De Corematrix has long focused on R&D and lean production with rigorous quality control. The MDR certification reflects TÜV Rheinland and EU market recognition of its technical, quality and system strengths.
De Corematrix will leverage this to boost innovation and quality, uphold “quality-driven, globally trusted” principles, serve domestic and international clients, and advance industry growth.