Skannex Regulatory

Regulatory

QA and Regulatory
  • Skannex Quality Management System and product development are performed according to ISO-13485
  • Skannex Hardware manufacturer is ISO-13485 certified and compliant with directives, relevant standards and GMP for medical devices in China and EU
Products
  • Skannex software, SkanMulti, is CE marked
  • SkanFlexi X200 and SkanFlexi X500 are both CE marked, SkanEasy is in the CE process
  • SkanFlexi X200 is approved in China by CFDA, SkanFlexi X500 is in the process