Skannex regulatory


QA and Regulatory

  • Skannex Quality Management System and product development is performed according to ISO-13485
  • Skannex Hardware manufacturer is ISO-13485 certified, and comply with directives, relevant standards and GMP for medical devices in China and EU
  • Skannex Software is CE marked


  • SkanMulti is CE marked
  • SkanFlexi is CE marked and approved in China by sFDA
  • SkanSmart is CE marked