Declaration of Conformity 符合性声明- 2010 MDD原件

DECLARATIONOFCONFORMITYTOCOUNCILDIRECTIVE93/42/EECOF14JUNE1993CONCERNINGMEDICALDEVICESRef:ENISO/IEC17050-1revisiondate:June2009MANUFACTURER:NAMEANDADDRESSMEDICALDEVICE:NAME,TYPEAND/ORMODELORSEEATTACHEDLIST-INCLUDEUMDNSAND/ORGMDN[NAMEANDCODE]CLASSIFICATION-ANNEXIX:E.G.CLASSIIA,RULE11CONFORMITYASSESSMENTROUTE:E.G.ANNEXVII+V.3WE,THEMANUFACTURER,HEREWITHDECLARETHATTHESTATEDMEDICALDEVICESMEETTHETRANSPOSITIONINTONATIONALLAW,THEPROVISIONSOFCOUNCILDIRECTIVE93/42/EECOF14JUNE1993CONCERNINGMEDICALDEVICES;INCLUDING,AT21MARCH2010,THEAMENDMENTSBYCOUNCILDIRECTIVE2007/47/EEC.ALLSUPPORTINGDOCUMENTATIONISRETAINEDATTHEPREMISESOFTHEMANUFACTURER.STANDARDSAPPLIED:ENISO13485:2003/AC2007,ENISO14971:2007,ENISO11135-1:2007,ENISO11607-1,ENISO11607-2,ENISO10993-1:2003,EN556-1,EN1041:2008,EN980:2008以及适用的产品协调标准，至于有哪些标准，具体察看协调标准网站NOTIFIEDBODY:TÜVSÜDPRODUCTSERVICEGMBHRIDLERSTR65,D-80339MÜNCHEN,GERMANYIDENTIFICATIONNUMBER0123(EC)CERTIFICATE(S):ECCERTIFICATE(S)NUMBER(S)SHOWONLYTHEECCERTSWITHASCOPETHATCOVERSTHEPRODUCTSLISTEDEUROPEANREPRESENTATIVE:ShanghaiInternationalTradingCorp.GmbH(Europe)Eiffestrasse,80,D-20537,Hamburg,GermanyTel:0086-021-65951371，0049-40-2513175，Fax:[phone]STARTOFCE-MARKING:DATEOFFIRSTCEMARKING(ORLOTORSERIALNUMBER)USUALLY=ISSUEDATEOFECCERT.(ANDADDENDDATE-WHENECCERT.VALIDITYENDS,ORWHENDEVICECEASESTOBEMARKETED,ORWHENNBISCHANGED)PLACE,DATEOFDECLARATION:CITY,DATESIGNATURE:____________________NAME:POSITION:(RESPONSIBLESENIOREXECUTIVEOFMANUFACTURER)