Nov. 22, 2023
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.
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Specializes in the industrialization and R&D of premium Minimally Invasive Surgery solutions worldwide
Surgical Stapling Series
Energy Sealing & Dissecting Platform
+86 021 5045 6176
399 Miaoqiao Road, Pudong District, Shanghai, China