Declaration of Conformity

Manufacturer：
Address：

European Representative ：

Product：
Model Code See attachment：

Classification (MDD, Annex IX): XX

We herewith declare that the above mentioned products meet the
provisions of the following EC Council Directives and
Standards. All supporting documentations are retained under
the premises of the manufacturer and the notified body.

DIRECTIVES

General applicable directives:

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14
June 1993 concerning medical devices (MDD 93/42/EEC).

Standard:

All applicable harmonized Standard (published in the Official
Journal of the European Communities)

Notified Body:

Certificate: XXXXXXXXXXXX

Expirate date of the Certificate:

Date CE mark was affixed: XXXXXX

Place, Date DD MM YYYY

Signature __________________________

Name

Position Head Regulatory Affairs, Management Representative