Chinese Medical Device Manufacturer Ezisurg Receives MDR Certification for Powered Endoscopic Stapler from TÜV Rheinland

Chinese Medical Device Manufacturer Ezisurg Receives MDR Certification for Powered Endoscopic Stapler from TÜV Rheinland

(IN BRIEF) TÜV Rheinland, an international third-party testing, inspection, and certification services provider, has awarded Ezisurg Medical Co., Ltd. its first MDR (Medical Device Regulation) certificate of conformity in Greater China for its “Disposable Powered Endoscopic Stapler and Cartridge.” This achievement allows Ezisurg Medical’s product to enter 27 EU countries, bolstering its global competitiveness. The Powered Endoscopic Stapler, the fourth iteration of Ezisurg Medical’s stapling series, is designed for various surgical procedures, including tissue transection, resection, and anastomosis. It has garnered an excellent reputation for clinical data completeness, product quality, and compliance with MDR technical requirements, earning approval from TÜV Rheinland’s global audit team.

(PRESS RELEASE) COLOGNE, 23-Nov-2023 — /EuropaWire/ — Recently, TÜV Rheinland, an international independent third-party testing, inspection and certification services provider, issued an MDR certificate of conformity to Ezisurg Medical Co., Ltd. (referred to as ” Ezisurg Medical”) for its “Disposable Powered Endoscopic Stapler and Cartridge” (referred to as “Powered Endoscopic Stapler”) based on REGULATION (EU) 2017/745. This is the first MDR certificate issued by TÜV Rheinland for this type of product in Greater China, meaning this product can smoothly enter 27 EU countries, further enhancing Ezisurg Medical’s international competitiveness.

Mohammed Dkhissi, Global Vice President of Medical of TÜV Rheinland Group, Wendy Geng, Vice President of TÜV Rheinland Greater China Medical, and Henry Nie, CEO of Ezisurg Medical jointly attended the award ceremony in Shanghai and exchanged views.

Ezisurg Medical is a high-tech company focusing on the research and development of medical devices for minimally invasive surgery in general, bariatric, thoracic, colorectal, urinary and respiratory procedures, founded in November 2011. Over the years, Ezisurg Medical has launched a product portfolio including staplers, ultrasonic scalpels, endoscopes, trocars, etc., and has established subsidiaries in the United States and the Netherlands, providing local customers with business operations and after-sales maintenance services, thereby enhancing its overseas service capabilities.

The Powered Endoscopic Stapler that passed the MDR compliance assessment this time is the fourth iteration of Ezisurg Medical’s stapling series, intended for tissue transection, resection, and/or creation of anastomoses in open and minimally invasive surgery. So far, Ezisurg Medical has supplied more than 4 million pieces of previous-generation stapling products for different types of surgeries around the world. Therefore, this Powered Endoscopic Stapler performs excellently in terms of completeness of clinical data, complies with relevant technical requirements of MDR in terms of product quality and management system compliance operations, and has successfully passed the evaluation of TÜV Rheinland global audit team.

Media Contact:

Jane Liang
T: 86 755 8268 1325
E: Jane.Liang@tuv.com

SOURCE: TÜV Rheinland