ificate Full Quality Assurance No, CE 00931 Issued to: C.R. Bard, Inc. 8195 Industrial Boulevard Covington Georgia a=) 30014 USA In respect of The design, development and manufacture of the products listed in the Supplementary Information: Page 2. on the basis of our examination under the requirements of Council Directive 99/42/EEC, Annex Il, Section 3.2. For and on behalf of the British Standards Institution, a Notified Body for the above Directive (Notified Body Number 0086) ase 4 nereererereerererereeecel 5 David W. Ford, Executive Director, Healthcare and Testing Services First Issued: 10 Oct 1998 Date: 7 Oct 2010 Expiration Date: 8 Oct 2015 Page: 1 of 2 Conditions of Approval Vat of tis certificate is conditional onthe quay system being maintained tothe requirements ofthe Directive. This approval excludes al products designed andlor manufactured by a thd party on behalf f the compar named (on tis certiete, unis specifealy agreed wih BS) me [eg J raising standards worldwide™ {he bn Sac tn, tdng a a consy creda he United Kngom by Raa Cate a4 wis laze aufero le inan, jana Poo npn 2 5 ‘Unted Kingdom ‘Moh (4480 768600 Web wn bsroupcom S| Group Hse 380 Chic igh Rud endon Wa 4A ase do 0996 S000, eaeertificate oo Supplementary Information to CE 00931 Issued to: C.R. Bard, Inc. Covington USA The design, development, manufacture of sterile Foley catheters and accessories (Including procedural kits and trays) and bladder temperature measuring device(s), urinary drainage/collection and volume measuring devices, urethral/intermittent catheters and accessories, ureteral catheter and accessories, urological guidewire and dilation products, suprapubic catheterization kits, percutaneous and suprapubic drains, ureteral stents, ureteroscopic and kidney stone removal devices and accessories, gastrointestinal drainage tubes and accessories, wound suction/drainage products, comparmental pressure monitoring device(s), irrigation syringes, urine and mucous specimen devices, respiratory care products, feeding tubes, securement devices for catheters with or without IV extension sets, biopsy devices, radio frequency and electrosurgical devices for ablation and coagulation of tissue, brachytherapy needles, specialty devices and bulking agents/delivery systems for Incontinence including Contigen® collagen iplant/delivery system, monitors and accessories for urodynamic evaluation of voiding dysfunctions, and pelvic prolapse repair products and accessories. The design, development, manufacture of nonsterile fecal and urinary incontinence devices, wound drainage products, ostomy products, bladder temperature/urine monitor, biopsy devices, and respiratory care products. First Issued: 10 Oct 1995, Date: 7 Oct 2010 Expiration Date: 9 Oct 2015 Pago: 2 of 2 =_ PJ raising standards worldwide” sn, eg 95, conpny corporeal by Rca awit plo aan Kevan Powe Moja ere Powel Herpnaa HP 8050165800 ve vary com 85 Ge Header 35 Chava nh Ao Ldn Wt SAW 4 (000998 000, onsenoe List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No. CE 00931 Date: 7 Oct 2010 Issued to: .R. Bard, Inc. Covington USA Subcontractor Allergan, Inc. 48490 Milmont Drive Freemont California USA Bard Limited Forest House, Brighton Road Crawley RH11 9BP West Sussex », United Kingdom Sterigenics Belgium (Petit-Rechain) SA Zoning Industrial de Petit-Rechain Avenue du Pare, 29 B-4800 Verviers, Belgium Bard Shannon San Geronimo Industrial Park Lot #1 Road #3, km 79.7 Humacao Puerto Rico USA raising standards worldwide™ Service(s) supplied Design Design of Packaging Manufacture EU Representative ETO Sterilization Manufacture Packaging Assembly Pasa =eace an by ap Car rdw lee bares Ke Hote Hajar ve Hd HeUradny preklad z anglického jazyka Certifikat Logo BSI Product Services Upiné zabezpeéenie kvality . CE 00931 Vydane: C.R. Bard, Inc. 8195 Industrial Boulevard Covington Georgia 30014 USA Tykajuce sa Navrh, vyvoj a vyroba produktov uvedenych v Dodatoénej informacii: strana 2. na zaklade nagho overenia poda poziadaviek Smernice 93/42/EHS, Priloha Il, ods. 3.2. Za av mene British Standards Institution (Britsky normalizaény institut), oboznameného organu pre horeuvedenti smernicu (¢. oboznémeného organu 0086): Neéitatefny podpis David W. Ford, vykonny riaditel, Sluzby zdravia a testovania Pruykrat vydané: 10. oktébra 1995 Datum: 7.oktébra 2010 Platny do: 9. okt6bra 2015 Strana 122 Podimionky schvalenia Platnost tohto certiikatu je podmienena systému kvalty, Kor) zachovava poziadavky smemnice. Toto schvalenie vyluéuje véetky vyrobky, ktoré boli navrhnuté a/alebo vyrobené trefou stranou v mene spoloénosti menovanej na tomto certifikéte, pokial nebolo so spoloénostou BSI dohodnuté inak. BSI Ussje spolosnosti BS!Certifikat Dodatoéna informacia k CE 00931 vwydané: C.R. Bard, Inc. Covington USA Navth, vjvoj a vjroba__sterilnjch Foley katétrov a prisiu’enstva (vratane pracovnjch nastrojov a podnosov) a zariadenia (zariadeni) na meranie teploty mechiira, mo¢ovych drenaanych / zbernjch zariadeni a zariadeni na meranie objemu, uretrdlnych intermitentnych (prerusovanych) katetrov a prisiuSenstva, uretralnych katétrov a prisiuSenstva, urologickych vodiacich drotov a dilataénych wjrobkov, suprapubickjch katetrizaénych nastrojov, perkuténnych a suprapubickych drenaznych odtokov, mogovodovych stentov, zariadenia a prislugenstva pre odstrafovanie_motovych aladvinovych kamefov, gastrointestindinych drendznych trubiek a prisiuSenstva, zariadeni pre odsavanie adrenaé ran, zariadenia pre monitorovanie vniitorného tlaku, irigatnych striekadiek, zariadenia pre odber vzoriek moée a hlienu, produkty pre podporu dychania, zariadenia pre ktmenie cez sondu (trubiéku) , zabezpetovacie zariadenia pre katétre s, alebo bez IV ( intravenéznymi ) predizovacimi supravami, zariadenia pre biopsiu, radiofrekvenéné a elektro- chirurgioké zariadenia pre ‘odstrafovanie a koagulaciu tkaniva, ihly pre _brachyterapiv, Specializovane nastroje a latky 2uzujiice priesvit motovej trubice ( bulking agents") fodvodove systémy pre inkontinenciu vratane kolagénového implantaéného/odvodového systému Contigen®, monitory a prisluenstvo pre Uurodynamické vyhodnotenie Gnikovych disfunkcii a produktov pre népravu poklesu organov panvy a prislusenstvo, Projekt, vyvoj, vjroba_nesteriinjch fekalnych a urindlnych inkontinenénjch nastrojov, produkly pre ‘drenaz ran, vyrobky pre stomiu, monitor teploly mechdira/ mocu, nastroje pre biopsiu a wyrobky pre podporu djchania, Pruykrat vydané: 10, oktébra 1995 Datum: 7.oktébra 2010 Platny do: 9. oktébra 2015 Strana 222 BSI \Udaje spolotnosti 8S!Certifikat Zoznam vyznamnych subdodavatelov certifikovanych pre poskytovanie sluzieb tykajticich sa vyrobku zahmutého v: certifikate €. CE 00931 Datum: 7. oktober 2010 Vydanj: C.R. Bard, Inc. Covington USA Subdodavater Poskytnuté sluzby Allergan, Inc. Navrh 48490 Milmont Drive Navrh obalu Freemont Vyroba Kalifornia USA Bard Limited Zastupca EU Forest House, Brighton Road Crawley RH11 9BP West Sussex Spojené kralovstvo Sterigenics Belgium Sterilizacia etylén oxidom (Petit-Rechain) SA Zoning Industrial de Petit-Rechain Avenue du Parc, 29 B-4800 Verviers Belgicko Bard Shannon Vyroba San Geronimo Industrial Park Lot &. 1 Obal Humacao Monta Porto Rico USA Strana 3 z0 4 P BSI Udaje spoiotnosti BSI9 Zadavatel: Stlus,s..0,, SR Ako timotniéka a prekladatelka anglického a nemeckého jazyka zapisana v zozname Znalcov, timoénikov a prekladatefov Ministerstva spravodlivosti Slovenskej republiky pod evidenénymi Gislami 950096 a 970669, potvrdzujem, Ze preklad stihlasi s textom pripojenej listiny. Prekladatelsky Ukon je zapisany pod poradowym islom (¢/ &/7 prekladatelského dennika. Bratislava, dia 47. L. Lo/L, 2 ee ih ‘odpis prekladatetky4 ee a — f