Ottobock 10V8 Instrucciones De Uso página 14

of this document, particularly due to improper use or unauthorised modi-
fication of the product.
5.2 CE conformity
This product meets the requirements of the European Directive 93 / 42 / EEC
for medical devices. This product has been classified as a class I device
according to the classification criteria outlined in Annex IX of the directive.
The declaration of conformity was therefore created by the manufacturer
with sole responsibility according to Annex VII of the directive.
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