Bye & Health Care {on eo Oop a a 08, en NIDEK CO.,LTD. 25" Document No BRQHOIGTONOREFIIIEUOY ECLARATION OF CONFORMIT Manufacturer's name _NIDEK Co Ltd, Manufacturer's addvess _ 14-14 Machama, Hishich, Gamagor, Ashi 19.0098, NIDEK sa European Representative _Buropare, 19 rue Auguste Perret, 94042 Créteil, France Mentifiestion of device _ AUTO REFIKERATO/TONO/PACHYMETER, Mosel No. TONORI Classification(Annex 1X, MDD) Category (Annex I, RoHS) 5 Classification(2000/289/EC, R&TTE) 1 We herewith declare under our sole responsibility that the above mentioned products meet the provisions of th following EC Council Directives and Standards, All supporting Aocumentation is retained under the premises of the manufacturer. The supporting technical documentation is also retained at NIDEK s.2., Europare, 19 rue Auguste Perret, 94042 Créteil, France, DIRECTIVES and STANDARDS — Date CE Mark General applicable directives Stan ao ‘COUNCIL DIRECTIVE 93D EEC [ EN ISOTSI85, EN ISOIA971, TECHOOD! (of 14 Jute 1993 concerning medical | IEC60601-1-2,TEC6O601-1-6, IEC6082S-1, rs Sevices 1EC62304,IEC52366, EN 18015004. 180180042, 8010342, 18010543, 108612, EN9S0, 1S015223-1,118Z0150 | _ O12 ‘COUNCIE DIRECTIVE | ENS0S81 over 1,2 AUIVESIEU of 8 une 2011 ‘concerning restriction ofthe use of| ‘certain. hazardous substances in lciricl and electronic equipment ‘COUNCIL DIRECTIVE 1999/5/EC [TECGO6OL-T, TECODSOT-I-2, over TE 2 fof 9 March 1999 on radio | ENG09S0-1, ENG23I1, ENG2479, ‘equipment and telecommunications | EN3O1 489-1, EN301 489-17, {ermisal equipmest and the mutual | EN300 328, recognition of thei conform Notified Body ‘TOV SUD Product Service GmbH, Ridlerstr. 65, 80339 Miinchen, Germany Certificate G1 13 07 23658 128 (Annex If, Section 3 of MDD) “Place: Aichi, Japan _ Bffective date: November 13, 2015 Signed by te of signature: Noy. | |, CO/e Corporate Advisor NIDEK Co,, Ltd