CE Certification Europe
Production Quality Management System Certificate:
MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH.
Notified body no: 0482
European Medical Devices Directive Annex V Certificate, No. 6408GB414090903, according to the Council Directive 93/42/EEC Medical Devices and EN ISO 13485:2003 + AC:2007 and Annex V, 93/42/EEC 3rd edition of the EN60601-1 Electrical Safety Directive, valid from 1 January 2010
Standards Applied:
ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for regulatory purposes
Manufacturer's Name: AussiMed Engineering
Medical Device: CyberTrone
Classification: Class IIa
