Certificates
Certificates as published by the manufacturer. Open any card for the full PDF.
ISO 13485Quality management systemOpen PDF
MDSAP 818101Medical Device Single Audit ProgramOpen PDF
US FDA 510(k) K212364BLTOpen PDF
US FDA 510(k) K192274BVOpen PDF
US FDA 510(k) K150388BCOpen PDF
MDL 108736BVOpen PDF
MDL 108486BL and BLTOpen PDF
MDL 108485TLOpen PDF
Australia ImplantsCertificateOpen PDF
Australia DrillsCertificateOpen PDFNeed registration or import documents for Egypt? Contact us.