Tokyo Hookd Modis. ne EC Declaration of Conformity ‘Tokyo Book Modisys ne. 4-44-21 Higashitoyode, Hine, Tokyo 181-0082, Japan Herowith declares conformity of tho product ‘The companyimanutacts Designation: ‘Automated Clinical Analyzer and its Spare Parts TypatSerial Numbor, ote: Blois 30), O2-Lite 270, SAPPHIRE 400 Promium, TMS 301, TOBO-270,ImmTox, SK300 “Soria No, sooorto%16 Manufactured at Hirose Electronic Systom Co, Lt Nasu Factory, 1635-1 Yonku-cho, Nasushiobara-shi, Tochigi 329°2746, Japan | nin applicable rogulations below | ee Directive: In vitro Diagnostic Medical Devices Directive: SHITOIEG - Annex! and Anwx Il IVD athe products iasstcavon: Non ist A Noni B and not for satestng ontoumiy Asaoesinon ase: WDD SB7QI Annex | ove so rnin | forts Direcve gl. | 2O1/6SIEU til Harmonized European Standards applied EN 6¢040-t: 2010 EN 61010-2.081; 29 rec e1oro2-101:21 EN etoaect: 2012 pathozed presenta a EU/ TO ole ‘spp Han Thanh in roa Sonaulting Gb Herlssts BO SEES. npr Gemary Ter anaes |A gas | KenpTakewent, | Manager of Quality Assurance Division [ior Tolyo, span [ee 26,2018(Second page ) ‘Allthe relevant accesseries and coneumabies 0-01-0047 0-01-0087 10-17-0208 20-22-0901 20-22-0991 20-29-0096 20-22-00060 20-20-0097 20-22-02970 20-22-0086, 20-72-0998 20-22-0099 20-22-09900 20-22-04 20-22-0025, ao a-o4rae aoa 044 20-2 015 20-21-0470 20-27-0077 20-27-0407F 20-20-0872 20-30-0884 120-20-08810 20-20-0699 20-20-0872 o-01-o04 20-20-0679, 2-07-0055 2-07-00550 220-0878 2420-06780 (0-00-00010 20-06-0107 o-72-016nF 0-72-0204, o-72-0205, ‘0-22-02650 520500 sp20se ‘spz0500 DP Steet, DP Stat (oops) Woshig Soin Took wthoat lovel suit Ast. Sample Cp odop23) Sample Cap 0 (100098 1000) Regent bot (2p with Ca) Reaent bot br o00pe= with Cap) Reagent ott 28m (20922 with Cp) Reagent hott 25m odDgcs wth Cap) Reagent ott 3m (20po8 with Cap) Reagent otto Co009¢8 with Cap) Reagent otto Cap Cope) Reagent botte Cap D 1000p) ‘Asie Wasting Seaton ‘eid Wasting Solution Reference Elecirade NotSedimleactrode K(Potaeumacrode (CkChirslEectroe Calrater + Pinch Vale Tae Sample Tb Catch Raising Ruber (Ope) Reagent bette 4 (20s with Cop) Reagent bt O at (100pe= wih Cap) Sample Holder New Type (IUpes) Reagent area Reade (th tachment & connects) Washing Saliton Aine W-TYEE (Fast Detergent | (DML xpos) eagontProbe sting Soliton Aline W-TYPE (Fast Detorgnt | (OL X5pee) Catt -8U (Opes) Civtte-2UD (20093) Dri Nace Tp (pes) Drying Roza Tp (oes) {SE Clearer) Halogen Lamo Assy. 0 (Opes / set) Patio sy ith Gonmoctr Calter Sat AD Feogent Botte ~T2 20m! (pes with on) agente = T20 2010000 thea eogentBotlo 240m!” (pes wi op) Reopen Botta ~T20 Al (1000p with cap) ator Fier pce) ator Fier D (Opes) Wash eohton Fiter pes) Wash sahtion Fier D (509) ‘kane Wasting Sobtionce Tokyo Hook! Medieys ine EC Declaration of Conformity ‘Tho companyimanutactior: Tokyo Bookt ted 451421 Higashitoyods, Hino, Tokyo 191-0052, Japan Herowith declares conformity of the product Designation ‘Automated Clinical Analyzer TypotSerial Number, ete: Boll 801 Superior, GIOLIS SD, TMS 60i Superior, SAPPHIRE £500 Superior, SAPPHIRE 500, 8K500, BIOCLIN 400, Touo-480 Serial No, ‘5000010810 ~ EMDA Code 210143 Manutactrod a Hirose Electronic Systom Co, Lid Nasu Factory 19354 Yonki-cho, Nasushiobara-i, Tochigi 828-2146, Japan 'SAO Y BAN CHINA] {With spptcabi regulations below ° is gta Ee Directv Machinery Directive bosiarce in Vitro Diagnostic Medical Devices Directive: SUIZSIEC Annex Land Annex Il, VD other products. Classification: Non-List A, Non-Lit 8 snd nat for soltnsting Conformity Assessment Route: IVDD 88/7HEC Annex EMC Directive : 2ovanoieu RoHS Directive 2OHSSIEU Harmonized European Stindards applied EN 610104 : 2003 EN 61040.2.081: 2002 +4, EN 6to10-2-104: 2002 EN 613264:2048 spun Sain Think EN ISO 14074: 2012 ENISO 19223-42016 EN EC 62308 2006 EN IEG 6oae8 ; 2008 Authorized representative in EU TCF holder 'M7 Promadt Consulting GmbH ‘ientotstrse 80, 0-66386 St, ngbert, Gormany Tol (49}-6894:581020 A Ge Fon Takeueh, ‘Manager af Quality Assurance Division ‘Tokyo Book! 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