Certifications

• FDA 510(k)- K070907, K163443
• EC Certificate – Full Quality Assurance System, Certificate No. CE 596785
• Certificate of Registration, Quality Management System – ISO 13485:2016, Cert. No. FM 596532
• MDSAP Certificate – Certificate No. MDSAP 686872
• Canada: Medical Device License 81976
• CB Test Certificate Ref. No. US-TUVR-8827
• Certified Foreign Medical Device Manufacturer, Japan, Cert. No. BG30402325