24
HiToP
®
191
gbo Medizintechnik AG
2005
Version 1.5
E C CERTIFICATE OF CON F O R M I TY
Name of manufacturer :
gbo Medizintechnik AG
Address
:
Kleiststrasse 6
D - 64668 Rimbach
Germany
We hereby declare under our sole responsibility that the product described below
conforms in design and make as well as in the versions delivered to the
corresponding safety and protection requirements defined in the applicable EC
regulations.
Harmonized standards have been used for all conformity checks, national
standards have not been applied.
Any change to the product design that is not validated by us will render this
declaration invalid.
Type of product
:
High Tone Power Therapy Device
Label
:
HiToP
®
191
Part-No. 017-0-0015
Options
:
none
Accessories
:
Description
Part-No.
Rubber electrode 115 x 175 mm
²
017-0-0046
Rubber electrode 80 x 120 mm
²
017-0-0047
Easy-Fix-Electrode 80 x 120 mm
²
017-0-0062
Corresponding EC regulations:
EC medical devices directive (93/42/EEC)
Conformity assessment
procedure
:
Annex II of the directive 93/42/EEC
Classification
:
IIa (according to MDD, appendix IX)
Name und registration no.
of the Notified Body
:
TÜV SÜD Product Service GmbH in Munich/Germany
with the registration no. 0123
Additional information
:
none
Date
:
February-1, 2007
Name of persons responsible :
Dr. Eberhard Keck
Title/Function
:
CEO
Signature
:
