Curatia Medical

Curatia Medical is a FDA, CE MDR, and CFDA-approved interventional disposables manufacturer headquartered in Sunnyvale, CA, with manufacturing operations in Suzhou, China. Founded in 2015, the company specializes in designing, manufacturing, and distributing single-use catheters and vascular access devices for cardiac, peripheral, neuro, and pulmonary interventional procedures. The product portfolio includes angiographic catheters (URSA®), guiding catheters (XCESS®), balloon dilatation catheters (Vela™, Bilia, Navajo®), introducer sheath sets (EXTesia), distal access catheters (HW-Flex), aspiration catheters (Laredo Plus), hemostasis valve kits (AutoSeal™), and long sheath sets (Crosera). EXTesia introducer sheath received FDA approval in April 2022; Crosera long sheath set obtained NMPA approval in August 2024. The company maintains ISO 13485:2016 certification, meets FDA 21 CFR Part 820, EU MDR (2017/745), NMPA YY/T 0287-2017, and Korea GMP standards. Curatia operates a global sales network spanning more than 30 countries across North America, Europe, South America, and Asia. The company also provides OEM manufacturing services for customers. Multiple unannounced FDA and TÜV SÜD on-site audits have resulted in zero findings, demonstrating compliance with quality and regulatory requirements.