Enztec is an MDR-certified, ISO 13485 manufacturer, compliant with CE (MDR), FDA, and TGA regulations, enabling sales in multiple international markets. Namely we can currently sell the OCI X/XR directly into Australia, Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom and United States. For some of these markets the Customer will need to act as the Importer and/or have their in-market regulatory teams complete country-specific registrations. We can also support sales into other countries through our Customers' in-market regulatory teams.