Soluscope
Contents
1. D05157B Soluscope EC MANUFACTURER S DECLARATION OF CONFORMITY D claration de conformit CE du Fabricant FULL QUALITY ASSURANCE SYSTEM Syst me complet d Assurance de Qualit Manufacturer s Name SOLUSCOPE Nom du Fabricant Address 100 rue du Fauge ZI Les Paluds 13400 AUBAGNE Adresse FRANCE Product Reference SL V3 PA UL R f rence du produit SOLUSCOPE SERIE 3 PA ULTRASOUND VERSION Classification of the Medical Device Class Il b Annex IX Rule number 15 Classe du Dispositif M dical Classe Il b Annexe IX R gle n 15 Type designation Washer disinfector D signation Laveur d sinfecteur Scope of Application Flexible endoscope reprocessing to be used exclusively Domaine d application with SOLUSCOPE C and SOLUSCOPE P amp A chemicals according to the user manual Nettoyage et d sinfection des endoscopes souples utiliser exclusivement avec les produits SOLUSCOPE C et SOLUSCOPE P amp A conform ment au manuel d utilisation GMDN Code amp Term 35628 Washer decontamination Code amp D signation GMDN endoscope flexible Notified Body 0843 Underwriters Lab International UK Organisme notifi Ltd Quality management System according to ISO 9001 2008 and to ISO 13485 2003 CE Marking ifi N 7 ifi Expiry 2017 Marquage CE Certificate No 537 Certificate Expiry 06 Sept 20 Certificate No 10383939 Certificate Expiry 06 Sept 2017 undersigned2. Jean Fran ois BIRY C E O of SOLUSCOPE SAS declare that the above mentioned device complies with the relevant provisions according to the European Directive 93 42 EEC concerning Medical Devices as amended Annex II with exemption of section 4 as transposed in the French decree N 2009 482 of 28 April 2009 and particularly fulfils the Essential Requirements according to the Annex l consequently the CE mark is affixed on the above cited device Je soussign Jean Fran ois BIRY P D G de SOLUSCOPE SAS d clare que le dispositif m dical d crit ci dessus est conforme aux dispositions qui le concernent selon l Annexe I l exception du point 4 de la Directive Europ enne 93 42 CEE amend e relative aux Dispositifs M dicaux transpos e en droit fran ais dans le d cret N 2009 482 du 28 04 2009 et en particulier satisfait aux Exigences Essentielles de l Annexe l en cons quence la marque CE est appos e sur ce dispositif m dical Date September 7 2014 www soluscope com 100 rue du Fauge Z I Les Paluds 13400 Aubagne France T l 33 0 4 91 83 21 22 Fax 33 0 4 91 83 21 10 E mail info soluscope com Soluscope SAS au capital de 11 700 000 Code APE 3250 A RCS Marseille 490918075 N TVA intracommunautaire FR 36490918075 Siret 49091807500048 Organisme de formation enregistr sous le num ro 93131375813 aupr s du pr fet de la r gion Provence Alpes C te d Azur
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