DECLARATION OF CONFORMITY Manufactuer: Aloka Co., Ltd. ‘Address: 22-1 Mure 6-chome, Mitaka-shi, Tokyo 181-8622 Japan European Representative: ALOKA GmbH Address: Molisfeld 5,D-40670 Meerbusch,Germany ee Ultrasound Diagnostic Equipment Model Cade SSD-a5 Classification (MOD, Annex IX) Ta We herewith declare that the above mentioned products including all its accessories 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 appicable directives: Medical Device Directive: Council Directive 93/42/EEC of 14 June 1993 conceming medical devices (MDD 93/42/EEC). Standards: Harmonized Standards (published in the Office Journal of he European Commurities) applicable to this product are EN 60601~1(1990)/A1(1993)/A2(1995) EN 60601-1~1(2001), EN 60601~1-2(2001) EN 60601-1-4(1996)/A1(1999) EN 60601-2-37(2001)/A1(2008), EN 980(2003) ‘Standards EN ISO 14971(2000)/A\1(2003) Noted body: TUV Product Service GmbH, Ridlerstrasse 65 D-80339 Munchen, Germany Start of CE marking: SN: M02296 Place: Tokyo Works, Aloka Co., Ltd. , Ueda Factory, Aloka Co., Ltd, — 26 Apr 2007 Siar AL bach, Name ofissuer: Norikazu Okada Position General Manager of Quality Assurance Department ALOKA CO,LTD. L-166J-12-85-04