F Care Systems EVRF - Declaration of Conformity

MANUAL THERMOCOAGULATION - EVRF
Date
26/06
/20
18
Page 13 of 34 Revision N° : 18
2.6 Declaration of conformity
DECLARATION OF CONFORMITY
We,
F Care Systems NV
Oosterveldlaan 99, B-2610 Wilrijk, Belgium
Hereby declare that under our sole responsibility that the CE marked product to which this
declaration relates.
Product type: Thermo-coagulator using radiofrequency ablation intended for
treatment of varicose veins, spider veins and hemorrhoids,
including treatment of the great saphenous vein (vena saphena
magna) and small saphenous vein (vena saphena parva).
Product name: EVRF
Has been classified as Class IIb, according to annex IX, rule 9, of the Medical Device
Directive93/42/EECand is in conformity with the essential requirements and provisions of the
Council Directive 93/42/EEC concerning medical devices. and is in conformity with the
relevant harmonized standards:
EN 1041:2008+A1:2013 EN 60601-1:2006/AC:2010
EN ISO 14971 :2012 EN 60601-1-2 : 2007
EN ISO 15223-1:2016 EN 60601-2-2:2009 + A11 (2012)
EN 62304:2006/AC:2008 EN 62366:2015
and is subject to the procedure set out in Annex II of the Council Directive 93/42/EC.
This declaration is made on base of quality assurance certificate.
N° BE 10/23574093
Delivered by SGS Belgium, N° 1639
Signed :
Name: Rudi Devers.
Function: Managing Director.