Declaration of Conformity:
Health Canada Medical Device Licences:
FDA Premarket Submission 510(k) K102253 registration:
FDA Premarket Submission 510(k) K113184 registration:
Management system fulfills the requirements of the ISO 13485:2003 standard.
A Quality Audit demonstrated compliance of the Quality Management System with DIN EN ISO 13485:2003...
An Audit demonstrated compliance of the Quality Management System with Annex II of the Council Directive 93/42/EEC concerning Medical Devices...
Ministry of Health of the Republic of Lithuania: Free Sale Certificate (Echo Blaster, LogicScan).
Health of the Republic of Lithuania: Free Sale Certificate (ClarUs).
South Korea FDA certificate: LogicScan 128 EXT-1Z Kit.
South Korea FDA certificate: Echo Blaster 128 EXT-1Z Kit.
Registration certificate of Russia: Echo Blaster 128 family scanners.
Certificate of Conformity, Russia: Echo Blaster 128 family scanners.
Registration certificate of Ukraine: Echo Blaster 128 family scanners.
Registration certificate of Uzbekistan: Echo Blaster family scanners.
Registration certificate of Peru: Echo Blaster 64/128 family scanners.