pascrencianescea Penumbra 49 Declaration of Conformity Manufacturer: Authorized EC Representative: Design / Manufacturing Facility: Product Category: Product Trade Name: Products: Classification: GMDN Code: Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA. MedPass International Ltd. Windsor House Barnett Way Barnwood, Gloucester GL4 3RT, UK Phone: +44 (0) 1452 619 222 Penumbra, Inc. 1351 Harbor Bay Parkway ‘Alameda, CA 94502, USA Catheter, embolectomy Penumbra System® See Attachment(s) Class III based on Annex IX, Rule 6 of Directive 93/42/EEC, as amended, Reperfusion Catheter: 58173 (Class III, Rule 6) ‘Separator: $8173 (Class Ill, Rule 6) Aspiration Tubing: 41978 (Class Ila, Rule 2) I, the undersigned, hereby declare that the Medical Device(s) specified above meet the provisions of Directive 93/42/EEC (MDD), as amended, including 2007/47/EC which apply to them, as transposed into the national laws of the EU member states. This declaration is supported by: ‘© The Penumbra, Inc. Quality System Certificate based on LS. EN ISO 13485; 2012 (MD19.4277, expiration date 20 August 2016), issued by NSAI (Dublin, Ireland). © The MDD Quality System Certificate, Annex II.3 of the EC Directive (252.711, expiration date 20 September 2015), issued by NSAI (Dublin, Ireland, CE 0050). + The Penumbra, Inc. EC Design Examination Certificate in accordance with Annex IL-4 of the EC- Directive (252.711, expiration date 20 September 2015), issued by NSAI (Dublin, Ireland, CE 0050). Signature: Mheha cla hla Date: C7 bet Zoe Name & Michaela Mahl Tae, Regulatory Affairs Program Manager Reviion pa. 7-0619 2! PageATTACHMENT TO THE DECLARATION OF CONFORMITY Product List: “Penumbra System” (Class III, Rule 6) Catalog Number Pscos4 PSCOS4L127 PSCOS4L125 PSCOS4MP127 PSCOS4MPI25 Psco4t Psco32 Psc026 4MAXC 4MAXC130 4MAXC125 4MAXCMP 4MAXCMP130 AMAXCMP125 3MAXC Pscos4 PSCOS4L127 PSCOS4L125 PSCOS4LI15 SMAXACE132 SMAXACE127 SMAXACE125 SMAXACELIS Pssos4 PSso41 PSS032 PSS026 PSFOS4 PSFO41 PSF032 PSF026 3MAXS, Pss3D Ps002 Pso02A S003 Pso04 Ps005 S006 S007 PSoO8 PSO02F PSOO2AF PSOO3F ‘Atachment oe Decaration of Contry for Peru Description Reperfusion Catheter 0S4 straight, 132 Reperfusion Catheter 054 straight, 127 Reperfusion Catheter 054 straight, 125 Reperfusion Catheter 054 MP shape, 127 Reperfusion Catheter 054 MP shape, 125 Reperfusion Catheter 041 Reperfusion Catheter 032 Reperfusion Catheter 026 Reperfusion Catheter 4MAX straight, 139 Reperfusion Catheter 4MAX straight, 130 Reperfusion Catheter 4MAX straight, 125 Reperfusion Catheter 4MAX MP shape, 139 Reperfusion Catheter 4MAX MP shape, 130 Reperfusion Catheter 4MAX MP shape, 125 Reperfusion Catheter 3MAX Reperfusion Catheter SMAX, 132 Reperfusion Catheter SMAX, 127 Reperfusion Catheter SMAX, 125 Reperfusion Catheter SMAX, 115 Reperfusion Catheter SMAX ACE, 132 Reperfusion Catheter SMAX ACE, 127 Reperfusion Catheter SMAX ACE, 125 Reperfusion Catheter SMAX ACE, 115 Separator 054 ‘Separator 041 Separator 032 Separator 026 ‘Separator Flex 054 / SMAX ‘Separator Flex 041 /4MAX Separator Flex 032 Separator Flex 026 ‘Separator 3MAX Separator 3D Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Penumbra System Ordering Convenience Code Revision per: 7-0ct-13 ‘Page 20f3ATTACHMENT TO THE DECLARATION OF CONFORMITY PSO04F Penumbra System Ordering Convenience Code PSOOSF Penumbra System Ordering Convenience Code PSO06F Penumbra System Ordering Convenience Code PS007F Penumbra System Ordering Convenience Code PSO08F Penumbra System Ordering Convenience Code (Class Ha, Rule 2) Pst Aspiration Tubing PsT2 MAX Aspiration Tubing » ‘Aracmact'o he Dacron of Cott fr Penumbra, he Revision por 7-0ct-13, — Page 30f 3PREKLAD Z ANGLICKEHO JAZYKA Penumbra £2 Vyhlasenie o zhode Vyrobea: Penumbra, Inc. 1361 Harbor Bay Parkway Alameda, CA 94502, USA Autorizovany zastupca ES: MedPass International Ltd. Windsor House Bamett Way Barnwood, Gloucester GL4 3RT, Spojené krafovstvo Telefon: +44 (0) 1452 619 222 Dizajnérske / vyrobné zariadenie: Penumbra, inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA Kategoria vjrobku Katéter, embolektémia Obchodny nazov vyrobku: Penumbra System’ Vyrobky: Pozrite prilohuly Kiasifikacia: Trieda_Ill_podfa prilohy IX, pravidlo 6 smemice 93/42/EHS v zneni neskorsich predpisov. Kod GMON: Reperfizny katéter: 58173 (trieda Ill, pravidlo 6) Odluéovaé: 58173 (trieda Ill, pravidio 6) Odsavacia hadicka: 41978 (trieda Ila, pravidio 2) Ja, dole podpisany, tymto vyhlasujem, 2e zdravotnicka pomécka, resp. pomécky uvedené vySsie 8 v sillade 5 ustanoveniami smemice 93/42/EHS (MDD) v zneni neskor8ich predpisov, vratane smemice 2007/47/ES, ktoré sa na ne vzfahujé a ktoré boli transponované do vnutrostatnych pravnych predpisov Clenskych statov EU. Toto vyhlasenie je podiozeneé: + Osvedéenim o systéme kvality Penumbra, Inc. podta I.S. EN ISO 13485: 2012 (MD 19.4277, datum skonéenia platnosti 20. augusta 2016), vydanym NSAI (Dubin, irsko). + Osvedéenim o systéme kvality MDD, priloha II.3 k smemici ES (252.711, datum skonéenia platnosti 20. septembra 2015), vydanym NSAI (Dublin, Irsko, CE 0050). + Certifikatom ES o preskumani konstrukéného navrhu Penumbra, Inc., v stlade s Prilohou 1.4 k smemici ES (252.711, datum skonéenia platnosti 20. septembra 2015), vydanym NSAI (Dublin, Irsko, CE 0050). Podpis: neéitatetny podpis__ Datum: 7. oktobra 2013 Meno Michaela Mahi afunkcia: — manazér regulatného programu Revitia 20 7. oktobra 2013 ‘rang 123Pscos4 PSCOS4L127 PSCOS4L125 PSCos4MP127 PSCos4mP12s PSCo4i Psco32 Psco26 4MAXC 4MAXC130 4MAXCI25 4MAXCMP 4MAXCMP130 4MAXCMPI25 3MAXC Pscos4 20S4L127 PSCOS4L125 PSCOSALLIS SMAXACE132 SMAXACE127 SMAXACE125 SMAXACEI15 Pssos4 Psso4i Pss032 PSs026 PSFOs4 PSFo4! PSFO32 PSFO26 3MAXS Pss3 Pso02 Pso02A Pso03 Psoo4 Psoos Ps006 S007 Ps008 Psoo2F PSOO2AF PSOO3F PRILOHA K VYHLASENIU O ZHODE Zoznam vyrobkov: ,,Systém Penumbra“ (trieda Ill, pravidio 6) Katalégové ¢islo Opis Reperfiizny katéter 054 rovny, 132 Reperfizzny katéter 054 rovny, 127 Reperfazny katéter 054 rovny, 125 Reperfiizny katéter 0S4 y tvare MP, 127 Reperfizany katéter 054 v tvare MP, 125 Reperfzny katéter 041 Reperfiuzny katéter 032 Reperfiizny katéter 026 Reperflizny katéter 4MAX rovny, 139 Repertitzny katéter 4MAX rovny, 130 Reperfitzny katéter 4MAX rovny, 125 Reperfitzny katéter 4MAX v tvare MP, 139 Reperfzny katéter 4MAX v tvare MP, 130 Reperfitzny katéter 4MAX v tvare MP, 125 Reperfizzny katéter 3MAX Reperfitzny katéter SMAX, 132 Reperfizzny katéter SMAX, 127 Reperfiizny katéter SMAX, 125 Reperfitzny katéter SMAX, 115 Reperfiizny katéter SMAX ACE, 132 Reperfizny katéter SMAX ACE, 127 Repertiizny katéter SMAX ACE, 125 Reperfiizny katéter SMAX ACE, 115 Odlutovas 054 Odluéovad 041 Odluovaé 032 Odlutovat 026 Odlutovad Flex 054 / SMAX Odlugovad Flex 041 /4MAX Odlutovad Flex 032 Odlueovad Flex 026 Odlutovat 3 MAX Odlucovat 3D Kod pre spravne usporiadanie systému Penumbra Kod pre spravne usporiadanie systému Penumbra Kod pre spravne usporiadanie systému Penumbra Kod pre spravne usporiadanie systému Penumbra Kod pre sprévne usporiadanie systému Penumbra Kod pre sprévne usporiadanie systému Penumbra K6d pre spravne usporiadanie systému Penumbra Kod pre spravne usporiadanie systému Penumbra Kd pre sprvne usporiadanie systému Penumbra Kod pre sprévne usporiadanie systému Penumbra Kéd pre sprivne usporiadanie systému Penumbra Piha k vyldseniao zhode pre spoloénost Penumbra. nc FRoviia 27, okt 2013 ‘ana 223PRILOHA K VYHLASENIU O ZHODE PSOOAF Kéd pre sprivne usporiadanie systému Penumbra PSOOSE éd pre spravne usporiadanie systému Penumbra PSOO6F od pre sprévne usporiadanie systému Penumbra PSOO7F Kéd pre sprévne usporiadanie systému Penumbra PSOOSE Kod pre spravne usporiadanie systému Penumbra (rieda Ila, pravidio 2) Pst Odsavacia hadicka pst MAX odsivacia haditka Prioha k vyldsents 0 zhode pre spolotnoet Penumbra. Ine Reviia x7. oktbbra 2013 strona 323RNDr. Anna Szulényiovi Durgalova 5 831 01 Bratislava Slovenski republika PREKLADATEESKA DOLOZKA Preklad som vypracovala ako prekladatelka zapisané v zozname znalcov, tImotnikov a prekladatefov, ktory vedie Ministerstvo spravodlivosti Slovenske} republiky v odbore slovensky jazyk —anglicky jazyk, evidentné éfslo prekladatel'a 970866. Prekladatelsky tdkon je zapisany v prekladate’skom denniku & 2 /2014 pod poradovym Gislom 36) 2014. Za prekladatel'sky tikon a vzniknuté néklady Wetujem pod! vytittovania na zaklade dokladué. 44/2014, V Bratislave dita $< ‘ls 2014 TRANSLATOR'S CLAUSE: Thave translated the source document as a translator registered in the List of E Interpreters and Translators maintained by the Ministry of Justice of the Slovak Republic, in the field Slovak - English Translations, under Translator's Reg. No. 970866. The translation is registered in the Translator’s Diary No. 2/2014 under No, S¢/ /2014. I charge you for the translation and the costs incurred on the basis of document No. 4/2014 In Bratislava on Ay"| 8, 2014