4/4 128957_V01_QSG_ASSIST_PLUS_EN.docx
Declaration of conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the device
complies with:
EU Directives and Regulations
2014/35/EU, 2014/30/EU, 2014/53/EU, 2012/19/EC, 2011/65/EC, 1907/2006, 2019/1782
S.I. 2016/1101, S.I. 2016/1091, S.I. 2017/1206, S.I. 2013/3113, S.I. 2012/3032
For detailed, signed CE declaration with regulations of other countries, please refer to the
operating instructions supplied with the device.