专注血管介/植入领域，成都医疗器械企业获国际权威认证

Core Viewpoint - Chengdu Niuchuang Medical Device Co., Ltd. has officially obtained ISO 13485:2016 certification, confirming its management system in the fields of neuro-interventional, peripheral interventional, and coronary interventional products meets international standards [1][4]. Company Overview - Niuchuang Medical, established in 2021, focuses on the vascular interventional/implantation field and is recognized as a national high-tech enterprise and a specialized and innovative enterprise [3]. - The company has developed the Niuchuang Feige™ peripheral papillary balloon dilation catheter, which is the world's first product of its kind [3]. Certification and Globalization - The ISO 13485 certification serves as a mandatory entry requirement for the international medical market, marking the official start of Niuchuang Medical's globalization journey [4]. - This certification is a comprehensive system certification for the entire company, not limited to specific products, allowing the company to provide safer and more reliable innovative medical device solutions globally [4]. Product Development and Market Position - In April 2023, the Niuchuang Feige® peripheral papillary balloon dilation catheter received approval from the National Medical Products Administration, with all three systems (35 system, 18 system, 14 system) now approved for market [6]. - The Niuchuang Feige® series is designed for percutaneous transluminal angioplasty of the peripheral vascular system and can also be used for the dilation of arteriovenous fistula stenosis, filling a gap in both domestic and international markets [6]. - The innovative product features a non-compliant high-pressure papillary balloon, providing greater dilation pressure to improve patient surgical success rates compared to traditional products [6]. R&D Achievements - Since its establishment, Niuchuang Medical has successfully developed dozens of products within a year and has achieved commercial capabilities with cumulative revenue reaching several tens of millions [7]. - As of the first quarter of 2025, the company has obtained 11 Class III product registration certificates and 2 Class II product registration certificates, with over 20 products in its portfolio [7]. Future Plans - Niuchuang Medical is investing in the construction of research and industrialization bases for vascular interventional/implantation products in Chengdu Tianfu International Bio-City, focusing on the development and production of interventional products for ischemic stroke, intracranial aneurysm treatment, and coronary artery stenosis [9]. - The company aims to establish standardized engineering laboratories, research centers, and public testing platforms for vascular interventional/implantation medical devices in the central and western regions [9].