器械РManufacturerРAddress РEuropeanРRepresentativeРProductРModel CodeРClassification:( MDD Annex IX): We herewith declare that the above mentioned product meet the provisions of the following EC Council Directive and Standards. All supporting documentation are retained under the premise of manufacturer and the notify body.РDIRECTIVESРGeneral Applicable Directive:.РMedical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical device (MDD 93/42/EEC )РStandard:РAll applicable harmonised standard ( published in the Official Journal of the munities )РNotify Body:TüV Product Service GmbH, Ridlerstr.65, РD-80339 Munich, GermanyРCertificate:G2D 99 11 36335 001РDate CE Certificate is Expired:РDate CE mark was affixed:РPlace, Date:РSignature:РName:РPosition: ManagingDirector
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