Seller shall ensure the product conforms to the following certifications, ratings and approvals: 1. FDA 510(k) 2. CE EN374 3. CE EN455-1-2-3 4. ISO 9001 5. ISO 13485 6. ASTM D6319 7. EU Type-Examination Certificate 8. PPE Regulation (EU) 2016/425 (Module C2) EN 374 CAT III 9. EN 420 10. EN 1186