CALTH Inc.

Calth Inc. specializes in in vitro diagnostic (IVD) tests. These include rapid diagnostic devices like the AllCheck Syphilis Anti-TP test for detecting syphilis, the Allcheck COVID-19 Ag test for identifying SARS-CoV-2, and the Allcheck Influenza A+B test for detecting influenza viruses. These products are designed for point-of-care or near-patient testing to quickly provide diagnostic results.

Calth Inc. is headquartered in South Korea. While the company’s devices are listed in the EU’s eudamed registry under the IVD General category, this does not imply regulatory approval for the EU market. Listing in eudamed is a transparency measure for devices that have undergone regulatory evaluation in the EU, but individual devices must still meet the specific requirements of the region where they are marketed or used.

Calth Inc.’s devices, such as the AllCheck tests, fall under Class C classification in the EU’s In Vitro Diagnostic Regulation (IVDR). This classification applies to devices that pose a moderate risk to patients and require a higher level of scrutiny during the regulatory process to ensure their safety, performance, and clinical effectiveness. The classification is determined based on factors like the intended use and potential health risks associated with incorrect results.

Yes, Calth Inc.’s devices are listed in the eudamed registry under the IVD General category. This registry is part of the EU’s transparency initiative, allowing stakeholders like healthcare providers, regulators, and manufacturers to verify the existence of devices that have been evaluated under EU regulations. However, listing in eudamed does not confirm market authorization—it simply indicates that the device has undergone regulatory scrutiny in the EU context, if applicable. Other regions may have separate registration or approval processes.