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2.6
Declaration de conformité
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:
Thermocoagulator 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
and 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 ISO 13485
IEC 60601-1
IEC 60601-1-2
and is subject to the procedure set out in Annex II of the Council Directive 93/42/EEC.
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
On: 03/08/2015
Date 27/07/2015
Directive93/42/EEC
EN ISO 14971
Page 15 de 52
THERMOCOAGULATION – EVRF
IEC 62304
IEC 60601-2-2
N° de révision : 14
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