Classification:( MDD Annex IX):
We herewith declare that the above mentioned product meet the provisions of the following EC Council Directive and Standards. All supporting documentation are retained under the premise of manufacturer and the notify body.
General Applicable Directive:.
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical device (MDD 93/42/EEC )
All applicable harmonised standard ( published in the Official Journal of the European Communities )
Notify Body:TüV Product Service GmbH, Ridlerstr.65,
D-80339 Munich, Germany
Certificate:G2D 99 11 36335 001
Date CE Certificate is Expired:
Date CE mark was affixed: