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BeijingJune 9, 2026 /PRNewswire/ — Recently, TÜV Rheinland Greater China, an international independent third-party testing, inspection, and certification body, issued a Notified Body certificate under the European Union Medical Device Regulation (Regulation (EU) 2017/745, referred to as MDR) for the radiofrequency generator and disposable intravenous radiofrequency closure catheter of Kunshan Rayson Medical Technology Co., Ltd. (hereinafter referred to as “Rayson Medical”). This marks the first MDR certificate issued by TÜV Rheinland Greater China for such products.
The certified radiofrequency generator and disposable intravenous radiofrequency closure catheter are primarily used for the clinical treatment of varicose veins of the lower extremities, specifically the great saphenous vein. As a key member of the Ruibridge Dingke Group, Rayson Medical has long been dedicated to the fields of chronic disease diagnosis and treatment and minimally invasive interventions, continuously refining product performance and improving its compliance management system. The venous radiofrequency ablation products certified this time strictly meet all indicators under the EU MDR regulation and relevant harmonized standards, which will help Rayson Medical steadily expand its international market.
TÜV Rheinland issues MDR Notified Body certificate for Rayson Medical’s venous radiofrequency ablation products
TÜV Rheinland issues MDR Notified Body certificate for Rayson Medical’s venous radiofrequency ablation products
Zhang Wenxiang, TÜV Rheinland Greater China’s Medical Device Services Certification Officer and Regional Manager for North China, congratulated Rayson Medical on obtaining the MDR certificate in his speech: “With the joint efforts of both parties, the progress of this project has been very smooth, setting a good example of close collaboration between the Notified Body and the manufacturer. From project initiation to certificate issuance, it took less than nine months, reflecting Rayson Medical’s comprehensive strength in product development, quality management, and regulatory compliance. We hope to maintain this positive momentum of cooperation. TÜV Rheinland will continue to assist outstanding Chinese medical device companies like Rayson Medical in enhancing their competitiveness in the international market, accelerating their global expansion through professional and efficient testing and certification services.”
As a Notified Body under the MDR and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), TÜV Rheinland possesses deep technical expertise and a global network of experts in the medical device field, offering comprehensive support to medical device companies. Its service scope covers MDR/IVDR conformity assessment, ISO 13485 system certification, Medical Device Single Audit Program (MDSAP) system certification, Brazilian INMETRO certification, as well as medical device testing services including safety, electromagnetic compatibility, performance, usability, and cybersecurity. Additionally, it provides full-dimensional compliance technical support and solutions in conjunction with the EU Artificial Intelligence Act (EU AI Act). In the future, TÜV Rheinland will continue to leverage its extensive industry experience and technical advantages to provide professional and efficient support for the international development of Chinese medical device companies, helping manufacturers quickly and compliantly enter overseas markets.