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ISO 13485 : 2016 CE · EU MDR 2017/745 DRAP ELI 00850 EN 868-5 ISO 11607-1 ISO 11140-1 AAMI EC12 Since 2012 120+ hospitals FSC export certified ISO 13485 : 2016 CE · EU MDR 2017/745 DRAP ELI 00850 EN 868-5 ISO 11607-1 ISO 11140-1 AAMI EC12 Since 2012 120+ hospitals FSC export certified