Certifications2018-08-07T14:38:48+00:00

Certifications

  • FDA 510(k)163443
  • EC Certificate – Full Quality Assurance System, Certificate No. CE 596785
  • Certificate of Registration, Quality Management System – ISO 13485:2003, Cert. No. FM 596532
  • Canada: Medical Device License 81976
  • CB Test Certificate Ref. No. US-TUVR-8827
  • Certified Foreign Medical Device Manufacturer, Japan, Cert. No. BG30402325