3D Systems Allevi 1, User Manual

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3D Systems, Inc. CD-000224-ENG
21
EC DECLARATION OF CONFORMITY (DoC)
We
Manufacturer:
3D Systems, Inc.
Address:
333 Three D Systems Circle Rock Hill, SC 29730
declare under sole responsibility for issuing this declaration of conformity in relation to the following Product(s):
Product Description: 3D Bioprinter
Model:
Allevi 3
Serial Number:
For the above given Product(s) is hereby declared that it conforms to the essential requirements set out in
community harmonization legislation mentioned below:
Machinery Directive 2006/42/EC
Electromagnetic Compatibility Directive 2014/30/EU of 14 October 2014
Radio Equipment Directive 2014/53/EU of 16 April 2014
Restriction of use of certain Hazardous Substances Directive 2011/65/EU of 7 January, 2011, Directive EU
2015/863 of 21 March, 2015
Statement about the relevant harmonized standards that have been used, or statement about the specifications in
relation to which conformity is declared (Standard: Date of Issue):
EN 12100:2010 IEC 61010-1:2010+A1:2016
IEC 61010-2-010:2014 EN 55032:2015+A11:2020
EN 55035:2017+A11:2020 EN 61000-3-2:2014
EN 61000-3-3:2013 EN 301 489-3 V2.1.1:2017
EN 301 489-1 V2.2.3:2019 EN 300 328 V2.2.2:2019
EN 50581:2012
Name of Person Authorized to compile the technical construction file: Jasper Vandendriessche
Grauwmeer 14, 3001 Leuven, Belgium
Local contact for regulatory topics
only:
North America Europe
3D Systems, Inc
333 Three D Systems Circle
Rock Hill, SC 29730, USA
3D Systems-Leuven
Grauwmeer 14, 3001
Leuven, Belgium
Signed for and on behalf of:
San Diego, CA, USA December 1, 2021
Place of issue Date of issue Doug Hoffman, Engineering Director