Certificates and Registrations


Certificates and Registration to ensure the quality, design, manufactury and distribution for the Gynocular and accessories that Gynius holds as a medical technology company.


FDA Registration
Department of Health and Human Services, Public Health Service

  • USA
  • China
  • Australia


ISO Certificates
Svensk Certifiering Norden, Management System Certificate

  • ISO 9001:2008
  • ISO 13485:2012


CE Approved
Läkemedelsverket the Medical Products Agency, Sweden

  • LVFS 2003:11
  • LVFS 2001:7
  • LVFS 2001:5



1. Certifiering