Regulatory
CE MARKING : The "EC DECLARATION OF CONFORMITY TO THE 93/42/EEC DIRECTIVE" has been obtained for the BMA product on september 21, 2006.

QUALITY ASSURANCE SYSTEM : D3A Medical Systems has obtained from SGS on August 11, 2006 the EC Certificate : "Full Quality Assurance System Approval Certificate" according to the Directive 93/42/CEE on Medical Devices.