E) SHIMADZU Declaration of conformity according to Medical Device Directive 93/42/EEC Manufacturer = SHIMADZU CORPORATION ‘Medical Systems Division Address : 1, NISHINOKYO-KUWABARACHO, NAKAGYO-KU,KYOTO,604-8511,JAPAN declares, in sole responsibility, that the following product Product name : Mobile X-ray Unit ModelName + ‘MUX-100H Parte Number : 503-48500-12 Which i compliance with Annes I for 93/42/EEC and which are certified for EN 60601-I,-1-3,-1-4,-2-7,-2-28,-2-32 standard by TOV Rhelnland as Certificate No. DE 2-007339 Also, this product is certified for Geprifters Medizinprodukt (GM) by TOV Rheinland Product Safety GmbH as Certification No. 150058357. ‘The company’s Quality System is satisfied with Annex Il, Article 3 for 93/42/BEC, which is certified by TOV Rheinland Product Safety GmbH (Nortified under No. 0197) as Registration No.: HD 60011592 0001 ‘The company named above will keep on file for review the following technical documentation: *operating and maintenance instructions ‘technical drawings * description of measures designed to measure conformity “other technical documentation, eg. quality assurance measures for design and production Importer/Distributor and Authorized Representative in EU SHIMADZU Deutschland GmbH Address “Albert-Hahn-Strasse 6-10,D-47269 Duisuburg, F.R.Germany Note: This declaration becomes invalid if technical or operational modifications are introduced without the manufacturer's consent. Iy.2005 issued date) Akins Ahiszyoone (gous) Akita Shit (full name) General Manager, Quality Assurance Dept Medical Systems Div. Shimadzu Comporation ___ (position)