17-48 Melfield Gardens

EU – Declaration of conformity

14.

I, the undersigned, hereby declare that the following products:

Ropox Flexi manual incl accessories, 30-65xxx-x

Declared products belong to risk class 1 cf. rule 4.1 of Annex 8 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and comply with this Regulation, harmonized standards and product standards:

Regulations and Directives

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices.

Council Directive 2006/42/EC on Machinery

Council Directive 2011/65/EU, RoHS

Council directive 2014/30/EU – EMC Directive

Standards

DS/EN ISO 13485:2016

DS/EN ISO 14971:2012

DS/EN 12182:2012

EN 55014-1:2006 + A1:2005 + A2:2011 EN 55014-2:1997 + A1:2001 + A2:2008

EN 61000-3-2:2014 EN 61000-3-3:2013

EN 60335-1:2012 + A11:2014 + A13:2017 EN 62233:2008

EN 50581:2012

EN ISO 12100:2010 EN 60204-1:2006 EN 349:1993+A1:2008

Næstved 28.05.2019

ROPOX A/S Ringstedgade 221 DK – 4700 Næstved Tel.: +45 55 75 05 00 Fax.: +45 55 75 05 50 E-mail: info@ropox.dk www.ropox.dk

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