Uroplasty Essential Incontinence Solutions

Transcription

1 MASTER Uroplasty Essential Incontinence Solutions DECLARATION OF CONFORMITY Annex II, Directive 93/42/EEC, 1993 Full Quality Assurance System Uroplasty Inc. ensures and declares that a full quality system (as specified in Section 3 of Annex II, Directive 93/42/EEC, 1993) for the design, manufacture and final inspection of the products listed below is applied and that the products concerned meet the provisions of Directive 93/42/EEC, 1993, as transposed into United Kingdom law (Le., Statutory Instrument 618), which apply to them. We further declare that IntertekiAMTAC Certification Services Limited is appointed as our Notified Body to undertake the provisions of Annex II of the directive. CLASSIFICA non CRITERIA (Annex IX, Directive 93/42/EEC, 1993) UROPLASTY Inc. MANUFACTURED PRODUCTS Product Name Catalog Number Classification Rule Urgent«lPC Neuromodulation System Stimulator Stimulation Lead Set Macroplastique~ Implants Bioplastique«l Implants VOX«lImplants PTQTMImplants E Z-GeI Lubricant Macroplastique«l Implantation System Adult Rigid Endoscopic Needles Pediatric Rigid Endoscopic Needle PTQ Rigid Needle UPC 100 (9) UPC200B (9) UPC ISO UPC 250 lla MPQ-2.5 MPQ-1.5 BPQ-I.O VOX-LO PTQ-2.5 EZ-IOOO (7) MIS-025 MIS-OI5 MRN-018 MRN-255 MRN-250 MRN-020 PRN-090 FM-0065 Rev.R E. Metcalfe 3 April 2012 Dca 1331 Page 1 of2

2 MASTER DECLARATION OF CONFORMITY (CONTINUED) Annex n, Directive 93/42/EEC, 1993 Full Quality Assurance System Product Name Catalog Number Classification 20 Gauge Cannula BPC-20G 20 Gauge Trocar BPP-20G These products are supported by the following Certificate of Authorization issued under the supervision of InterteklAMTAC Certification Services, LTD., a Notified Body duly authorized by the United Kingdom Competent Authority to carry out such assessments and bearing the Notified Body Number Certificate of Authorization Number: 068CE ~ 1 ' /1~A.1.J/i,,;Jl Michael Morrell Director of Regulatory Affairs and Quality Assurance Uroplasty, Inc.!\prJ :3) do I }- Date. Rev.R E. Metcalfe 3 April 2012 DCO 1331 Page 2 of2

3 Preklad:: anglickeho do slovenskeho ja::yka Translation from the English language to the Slovak language HLAVNY DOKUMENT Uy'oplasty Zasadne riesenia pre inkontinenciu VYHLAsE IE 0 ZHODE Priloha II., smernica 93/42/EHS, 1993 System uplneho zabezpecenia kvality Spolocnost' Uroplasty Inc. potvrdzuje a vyhlasuje, ze uplatnuje system uplneho zabezpecenia kvality (podl'a bodu 3 prilohy II. smernice 93/42/EHS) pre navrh, vjrobu a konecnu kontrolu nizsie uvedenych ryrobkov a ze tieto ryrobky vyhovuju prislusnym ustanoveniam smernice 93/42/EHS transponovanym do pravneho poriadku Spojeneho kral'ovstva (zakonnym predpisom c. 618), ktore sa na tieto vjrobky vzt'ahuju. Dalej prehlasujeme, ze spolocnost' Intertek/ AMT AC Certification Services Limited je ustanovena za nas notifikovany organ na ucely ustanoveni prilohy II. uvedenej smernice KLASIFIKACNE KRITERIA (Priloha IX. Smernice 93/42/EHS, 1993) vyrobky VYRABANE SPOLOCNOSTOU UROPLASTY Inc. azov yfrobku Katal6gove cislo Klasifikacia Pravidlo Stimulator pre neuromodulacny system Urgent PC Sada stimulacnych kablov UPC 100 UPC 200B UPC 150 UPC 250 (9) (9) Macroplastique MPQ-2.5 MPQ-I.5 Bioplastique BPQ-I.O VOX VOX-LO PTQ PTQ-2.5 Lubrikacny gel E_Z_GeI EZ-IOOO lia (7) Implantacny system Macroplastique MIS-025 MIS-OI5 Pevne endoskopicke ihly pre dospelych MRN-O 18 MRN-255 MRN-250 lia Pediatricka pevna endoskopicka ihla MR -020 Pevna ihla PTQ PRN Rev. r E. Metcalfe 3. aprila 2012 DCO 1331 Strana 1 z 2

4 HLAVNY DOKUMENT " VYHLASENIE 0 ZHODE Priloha II., smernica 93/42/EHS, 1993 System uplneho zabezpecenia kvality azov tirobku Katal6gove cislo Klasifikacia Pravidlo Kanyla, rozmer 20 BPC-20G Trokar, rozmer 20 BPP-20G I1a Uvedene ryrobky su podporene nadvazujucim certifikatom 0 schvalenf vydanym pod dohl'adom spolocnosti Intertek/AMTAC Certification Services LTD. ako notifikovaneho organu s cfslom 0473 riadne opravneneho prfslusnym organom Spojeneho kral'ovstva vykonavat' take to posudenia. Cislo certifikatu 0 schvaleni: 068CE (Podpis] 3. april 2012 Michael Morell Riaditel' pre regulacne zalezitosti a zabezpecovanie Uroplasty, Inc. kvality Datum FM-0065 Rev. r E. Metcalfe 3. aprila 2012 DCO 1331 Strana 2 z 2

5 Prek/ad anglickeho textu priloieneho dokumentu som vypracova/a ako prek/adatel'ka zap s'ana v zozname zna/cov, t/mocnikov a prek/adatel'ov vedenom Ministerstvom spravodlivosti S/ovenskej republiky v odbore s/ovensky jazyk - anglicky jazyk pod evidencnym cis/om Prek/adatel'sky likon je zapisany pod poradovym cis/om: 75/2013 prek/adatel'skeho dennika C. 01/2013. Za prekladatel'sky likon a vzniknute naklady lictujem podl'a vylictovania na zak/ade dokladu C. PD 19/2013. V Povaiskej Bystrici dna ( I