Source: Originally published by TÜV Rheinland Greater China on 27^th August, 2026.

Original article（from TÜV Rheinland Official WeChat Service Account）

English translation: Prepared by TransEasy Medical Technology Co., Ltd. for international communication purposes.

On August 25, TÜV Rheinland Greater China, an international independent third-party testing, inspection and certification organization from Germany (hereinafter referred to as “TÜV Rheinland”), awarded Medical Device Regulation (EU) 2017/745 (MDR) Notified Body certificates to two Class III medical devices of TransEasy Medical Tech. Co., Ltd. (hereinafter referred to as “TransEasy Medical”): EasyProsthes® Surgical Meshes and DegraTack® Pre-loaded Absorbable Tacks.

 

This indicates that the two high-risk hernia and abdominal wall surgical medical devices manufactured in China meet the regulatory requirements for the EU market and also establish a compliant foundation for TransEasy Medical to further expand into the global market. Based on currently available information from publicly accessible EU regulatory databases and industry sources, TransEasy Medical is at the forefront among Chinese manufacturers in obtaining EU MDR Notified Body certificates for Surgical Mesh and Pre-loaded Absorbable Tacks.

Zheng Zhiguo, General Manager and Executive Director of TransEasy Medical; Xie Qingsong, Executive Deputy General Manager; Zhang Xiangdong, Deputy General Manager; Mohammed Dkhissi, Vice President, Global Medical Devices Services, TÜV Rheinland; Geng Wen, Vice President, Medical Devices Services, Greater China; Zhang Wenxiang, Regional Manager, Northern China; and other representatives from both parties attended the event.

 

Mohammed Dkhissi said: “MDR has long been regarded as one of the most stringent regulatory frameworks in the global medical device industry. It sets extremely high requirements for the full life-cycle management, clinical evidence, quality systems and risk management of medical devices. In particular, for Class III high-risk medical devices, the application process is more complex and the technical requirements are higher. The successful certification of TransEasy Medical’s two core hernia surgery products is a landmark breakthrough in China’s hernia repair field, and also demonstrates that the technical capabilities and compliance level of Chinese-manufactured hernia surgical devices have reached international standards.”

 

The EasyProsthes® Surgical Meshes covered by this certification are indicated to reinforce soft tissue where weakness exists during open or laparoscopic procedures, i.e., repair of inguinal hernias. DegraTack® Pre-loaded Absorbable Tacks is intended for fixation of hernia mesh to soft tissue in laparoscopic or open general surgical procedures, including primary abdominal wall hernia repair, secondary/incisional abdominal wall hernia repair, and abdominal wall reconstruction. Both products are classified as Class III medical devices and are key consumables used in hernia and abdominal wall surgery.

 

Zheng Zhiguo said during the discussion: “The acquisition of the MDR certificates is an important milestone in TransEasy Medical’s internationalization process. On the one hand, it demonstrates that the company’s capabilities across the entire chain, including product design and development, production quality control, risk management and clinical evaluation, meet international standards. On the other hand, it opens a channel for high-end Chinese-made hernia surgical medical devices to enter the EU market, helping high-quality Chinese-made medical devices expand globally. In the future, TransEasy Medical will continue to focus on clinical needs, remain committed to technological innovation, continuously improve its product portfolio, further consolidate its advantages in the domestic market, and steadily advance its global strategy, so that more high-quality Chinese-made medical devices can serve patients and healthcare professionals both in China and overseas.”

 

Geng Wen said: “In recent years, with the continuous improvement of domestic material science, precision manufacturing and clinical translation capabilities, the application of Chinese-made hernia surgical devices in domestic clinical practice has become increasingly mature. Some high-end product categories have already established a foundation for competing alongside international brands, and overseas markets will become the next major area of focus. As an MDR Notified Body, TÜV Rheinland relies on localized project teams and has long supported Chinese medical device companies in expanding overseas, with a greater focus on whether companies can establish long-term compliance capabilities oriented toward global markets. In the future, TÜV Rheinland will continue to leverage its professional strengths as an international third-party organization to support more innovative Chinese medical device companies such as TransEasy Medical in enhancing their international compliance capabilities and promoting high-quality Chinese-made medical devices into the EU and other overseas markets.”

 

As a Notified Body for MDR and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), TÜV Rheinland has extensive technical expertise and a global network of experts in the medical device field, and can provide comprehensive support to medical device companies. Its services cover MDR/IVDR conformity assessment, ISO 13485 management system certification, Medical Device Single Audit Program (MDSAP) certification, Brazil INMETRO certification, as well as medical device testing services including safety, electromagnetic compatibility, performance, usability and cybersecurity. It can also provide comprehensive compliance technical support and solutions in conjunction with the EU Artificial Intelligence Act (EU AI Act).

 

In the future, TÜV Rheinland will continue to provide professional and efficient support for the international development of Chinese medical device companies through its extensive industry experience and technical expertise, helping manufacturers achieve compliance and enter overseas markets efficiently.

 

About TransEasy Medical

 

TransEasy Medical Tech. Co., Ltd. was established in November 2002. It is a National High-Tech Enterprise specializing in the R&D, manufacturing and sales of general surgical medical devices, including products for hernia and abdominal wall surgery. With more than 20 years of experience in the hernia surgery field, the company has continuously developed and refined its range of domestically manufactured hernia repair products and is a leading company in the field of hernia and abdominal wall surgery in China.

 

Translation and Source Notice This English version is a translation of the original Chinese article published by TÜV Rheinland Greater China on 27^th August, 2026.

 

References to EU MDR certification apply only to the products and certification scope specified in the applicable certificates.

 

Published on TransEasy website: 28^th August, 2026

 

Disclaimer: This content does not constitute any form of medical advice or product promotion. For any medical concerns or diagnosis, please consult a qualified healthcare professional.