Dexcowin

Dexcowin specializes in portable X-ray systems, including models for general radiography and specialized dental applications. These devices are designed for on-site imaging in clinical, veterinary, or field settings, providing flexibility for diagnostic procedures.

Dexcowin is based in South Korea, though its portable X-ray systems are specifically registered in the EUDAQS database (eudamed) under EU regulations. This indicates the company’s devices are intended for use within the European Economic Area and comply with applicable EU medical device directives.

Dexcowin’s portable X-ray systems are listed in the EUDAQS database (eudamed), which is the official EU registry for medical devices. This registration is required for devices marketed in the European Economic Area to demonstrate compliance with EU medical device regulations.

Dexcowin’s portable X-ray systems fall under Class IIb classification in the EU. This classification is assigned based on risk assessment criteria—Class IIb devices pose moderate to high risks and require additional scrutiny, such as conformity assessment procedures, to ensure safety and performance before market placement.