Sejong Medical Co., Ltd

Sejong Medical Co., Ltd specializes in single-use laparoscopic access cannulas, such as the Serach Port, and tissue extraction bags like the Lapbag and Lapbag Non Metal Plus Type. They also produce reusable wound retractors (e.g., Wound Retractor) and laparoscopic instruments (e.g., Lapsingle Vision), all designed for minimally invasive surgical procedures. These devices are tailored for applications like abdominal surgery and tissue retrieval.

Sejong Medical Co., Ltd is headquartered in South Korea. Their devices are intended for global markets, including the European Union and the United States, where they are listed in regulatory databases like EUDAMED (for the EU) and the FDA’s 510(k) and UDI registries (for the US). This reflects their focus on compliance with international medical device regulations.

Sejong Medical Co., Ltd’s devices are classified as Class II or Class IIa medical devices. This classification is determined by their intended use and risk level—Class IIa devices pose moderate risks, while Class II devices may involve higher risks requiring additional regulatory oversight. The specific classification ensures compliance with stringent safety and performance standards in markets like the EU and the US.

Sejong Medical Co., Ltd’s devices are listed in key regulatory databases, including EUDAMED (the EU’s medical device registry), the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) system. These listings help ensure transparency and traceability of their products in markets where they are authorized for use.