Healcerion Co., Ltd.

Healcerion Co., Ltd. specializes in general-purpose ultrasound imaging systems. These devices are designed for diagnostic purposes, allowing medical professionals to visualize internal body structures in real-time. Examples include models like the SONON 300L, SONON 500L, and SONON300C, which are intended for use in clinical settings.

Healcerion Co., Ltd. is headquartered in South Korea. The company’s location influences its regulatory compliance processes, particularly for devices marketed in international markets like the EU and the US.

Healcerion Co., Ltd.’s ultrasound systems are included in multiple regulatory databases: eudamed (for EU market compliance), the FDA’s 510(k) premarket notification database (for US market clearance), and the FDA’s Unique Device Identifier (UDI) system (to track devices post-market). These listings help ensure transparency and traceability of the devices in their respective regulatory environments.

Healcerion Co., Ltd.’s ultrasound imaging systems fall under Class II and Class IIa regulatory classifications. Class II devices typically pose moderate risks and require special controls to ensure safety and effectiveness, while Class IIa devices are a subset with slightly lower risk. These classifications determine the regulatory scrutiny and documentation requirements for each device model.