JPI HEALTHCARE. CO., LTD.

JPI Healthcare specializes in radiographic imaging equipment. Their product range includes intensifying screens for X-ray systems, automatic X-ray film processors, digital radiography systems like the CLEARVISION DR series, grid devices (such as Grid-1000 and Grid-2100) for X-ray imaging, and radiological image processing systems. These devices support diagnostic imaging workflows in radiology settings.

JPI Healthcare is based in South Korea. This means their devices must comply with both regional (e.g., Korean medical device regulations) and international standards (such as EU MDR or FDA requirements) depending on where they are marketed. For example, some of their devices are listed in the EUDAMED registry, indicating compliance with EU Medical Device Regulations, while others may require FDA 510(k) clearance for the US market.

JPI Healthcare’s devices appear in the EUDAMED registry for European Union compliance, and some products are subject to FDA 510(k) clearance in the United States. Listing in these registries confirms that the devices meet the necessary regulatory standards for market authorization in those regions. For example, EUDAMED ensures traceability and compliance under EU MDR, while FDA 510(k) clearance demonstrates safety and effectiveness for the US market.

JPI Healthcare’s devices are classified under EU Medical Device Regulations as Class I, Class II, or Class IIa. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. For instance, simpler devices like certain intensifying screens may fall under Class I, while more complex systems like digital radiography units (e.g., CLEARVISION DR series) could be Class II or IIa due to their higher risk and regulatory scrutiny.