Good News: Shandong Steve Medical Technology Co., Ltd. Successfully Obtains EU MDR Certification

Recently, the core products of Shandong Steve Medical Technology Co., Ltd. (hereinafter referred to as the “Company”) — polymer silicone medical devices (including urinary catheters, gastric tubes, respiratory anesthesia circuits, abdominal drainage tubes, and negative pressure drainage devices) — have successfully passed the certification of the European Union Medical Device Regulation (REGULATION (EU) 2017/745, referred to as MDR), and officially obtained the legal qualification to enter the EU market.

The EU MDR is one of the most stringent medical device regulations in the world currently, imposing extremely high requirements on product whole-life cycle safety, clinical evidence, and quality control systems. The successful passing of this certification fully demonstrates that the Company’s product quality and management level are fully compliant with EU standards.

In the future, taking this certification as an opportunity, the Company will continue to deepen its presence in the medical device field, further expand domestic and international markets, and provide high-quality “Made in China” products and services for the global medical and healthy industry.