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SELF DECLARATION OF CONFORMITY

EC Representative's Name:         Richard Klukovich

Equipment Description:                 An esthetic system destined to aesthetical centers only                                                       as it is not considered to be for medical use.

Equipment  Model:                         Vascutouch/Touch 150

SAFETY STANDARDS
UL2601-1, TUV EN60601-1-2, IEC601-1

EMC STANDARDS:          
EN55011 class B, EN61000-4-2,3,4,5,6,8,11, EN61000-3-2,3, EN60601-1-2, ENV50204

EC-CONFORMITY DECLARATION
Tested to Medical standards - Medical Device Directive (93/42/EEC)
EN60601-1: MPx-yz SERIES TUV CERTIFICATE# TA5000971301

TUV CERTIFICATE# TA5000971301
EN60601-1:1990+A1+A2
IEC 606011-1:1988+A1+A2

TUV CERTIFICATE# TA 50009713 02
EN60601-1:1990+A1+A2+A13
IEC60601-1:1988+A1+A2

CB TEST CERTIFICATE DE 2-004835

Although tested to medical standards, we declare that the unit above does not need the Directive 93/42 as the usage is strictly aesthetical and is not considered to be for medical use.