Certificate of CE Registration (Authorized Representatives)


ISO 13485:2016 Certificate of Registration

Medical Device Single Audit Program (MDSAP) Certificate


Declarations of Conformity - EU MDR Manual Steppers

Declarations of Conformity – EU MDR Stabilizers


























Declarations of Conformity – EU MDR Tracked Steppers

EU MDR 2017/745 Certificate

Declarations of Conformity – EU MDR Endocavity Guidance


























Declarations of Conformity – EU MDR Endocavity Standoff
























Declarations of Conformity – EU MDR Gel-Free Covers






















Declarations of Conformity – EU MDR General Purpose and Intraoperative Covers

























Declarations of Conformity – EU MDR General Purpose Guidance In-Plane, Fixed Angle

























Declarations of Conformity – EU MDR General Purpose Guidance In-Plane, Open Channel

























Declarations of Conformity – EU MDR General Purpose Guidance Out-of-Plane, Fixed Angle

























Declarations of Conformity – EU MDR Intracavity Covers

























Declarations of Conformity – EU MDR Needle Tip Tracking

























Declarations of Conformity – EU MDR System and Equipment Drapes

























Declarations of Conformity – EU MDR Transperineal Guide