BJ BRAUN. O!o/oi3. EC Declaration of conformity. 3 ( r 2.J Date: FLEXÍMA/SOFTIMA 35. BASE PLA TE Ef CLOSED OR ORA INASLE OR HIGH FLOW POUCH
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1 au capital dn C APE 3250 A EaxOl W Corresponciing to the attached product listing, are class I medical clevices. 93/42/EEC concerning medical devices which apply to it. ;- Skg Social Revision: Q3d of June 2013 In addition we certify that the above mentioned product group meets au requirements of the DIRECTIVE sole responsibility, that the product group: First issue: 1 7 oř December Signature I Rcgulatory Oeclaration CE conformt DM non 5térII Ise 8BMFMS i -D EN I We hereby, B. Braun Medical, 204, avenue du Maréchal iuin, Boulogne Cedex, France, declare under According to annex VII of the Directive 93/42/EEC concerning Medical Devices EC Declaration of conformity 204, avenue du MarÉcha Juin F Boulogne Cedex BJ BRAUN B.Braun Medical S.A.S. 2 10? Boulogrie Ccix Société pr Actioris Simplitiée Laboratair Phrmaccutiqu Sirn vcnu dlj MarchaI Juin RCS Nantnrc Date: 3 ( r 2.J Date: O!o/oi3 Name Isabelle DESPLAT Name : Ludovic ETCHEVERRY Affairs Quality Et Regulatory Affairs BASE PLA TE Ef CLOSED OR ORA INASLE OR HIGH FLOW POUCH FLEXÍMA/SOFTIMA 35
2 High Flow Pouch. PRODUCT RANGE Base Plate Et Closed or Drainable or PRQDUCT LIST EC Declaration of conformity au capital de APE 3250 A F Bouogne Cedex Fax S3 99 Socit par Actions SImplifie Sircn , avenue du Maréchal JuÉn TéI Laboratoir Phrmaceutique RCS Nantcrre Siege SDciaI Dclaration CE d conformté Prodit List BBMF M D-EN First issue 7 of Decem ber Revision 03 of June 2013 Signawre Signature Date: ( c 2 Date: Name : Isabelle DESPLAT Nariie Ludovic ETCHEVERRY Rcgulatory Affairs Quality Et Regulatory Affairs (ot number). Date of first EC-marking (or first 17 ih of December 2012 See attached product list REFERENCE PRODUCT (Drainable pouches). GMDN code (es) surgery Of the enterostomy type.. Intended use Twopiece couection system for patients having undergone a O Sterile / Non sterile Non sterile. Class I III F Boulogne CedeX 204, avenue du Maréchal Juin BBRAUN B.Braun Medical S.A.S.
3 BIBRAUN ECDeclaration_of conformity B.Braun Medical S.A.S. 204, avenue du Maréchal Juin F Boulogne Cedex FLEXIMA/SOFTIMA 3S Base plate Et closed or drainable or high flow pouch Table 1: Flexima/Softima 3S base plates CODE Box ot / SPECIFIC PACKAGING DESIGNATION REFERENCES (mm) XX FLEXIMA/SOFFIMA3S 5 Or 10 products XY Base plate 045 K FLEXIMAJSOFTIMA 35 Box of S or 10 products Base plate O 45 / FLEXI MA/SOFTI MÁ 35 Box ot S ar 10 products Base plate O 45 J Box of 5 or 10 products Base plate O 45 J XX FLEXIMA/SOFTIMA3S Box ot 5 10 products XY Base plate ar 055 K e FLEXIMAISOFTIMA 35 Box ot 5 or 10 products Base plate Box ot 5 or 10 products Box FLEXIMA/SOFTIMÁ 35 Base plate XX FLEXIMA/SOFIIMA3S 10 products XY Base plate ať Sor FLEXIMAJSOFTIMA 35 Box of 5 ar 10 produc[s Base plate O 55 I 35 O 55 I K15-50 O 65 / 45 Box of XX FLEXIMA/SOFTIMA3S 5 praciucts XY Base plate orio 080 K
4 Beige BERAUN EC Declaration of conformity B.Braun Medical S.A.S. 204, avenue du Maréchal Juin F Boulogne Cedex Table 2: Flexima/Softima 35 closed pouches CODE / PACKAGING Box Of 30 Or 50 products SPECI FIC POUCH DESIGNATION COLOUR I REFERENCES SlZE J (mm) Ctosed pouch Transparent Transparent Closeci pouch MAXI Transparent 65 Transparent 80 Beige FLEXIMA/SOFFIMA 35 Beige Beige Beige Box of 30 or 50 proclucts FLEXI MA/SOFÍIMA 35 Closed poueh Transparent 45 I Closed po uch MIDI Transparent 55 Beige Box oř 10, 30 Or 50 products XX XY FLEXIMA/SOF[IMA 35 Beiqe _Box_of 10, 30 or 50 products XX XY FLEXI MA/5O FÍIMA Box oí 30 or 50 products FLEXIMA/SOFVIMA 35 MINI Beige 45 Beige 55 2/4
5 BIBRAUN EC Declaration of conformity 1 Table 3: Flexima/Softima 3S RoII Up drainable pouches B.Braun Medical S.A.S. 204, avenue du Maréchal iuin F Boulogne Cedex SPECIFIC POIJCH r?j CODE/ PACKAGING DESIGNATIQN COLOUR REFERENCES SlZE (mm) oř 30 Or 50 prociucts Box of 30 Or 5oproducts Box of 30 or 50 praducts Box oř 30 or5o products RoII Upcirainable pouch - FLEXIMA/SOFJIMA 35 RoIľUp drainablepouch FLEXIMA/SOFI1MA 35 RoIľUp drainable pouch RoIIUp drainable pouch RoIľUp drainable pouch MAXI Transparent 45 Transparent 55 Transparent 65 Transparent 80 Beige FLEXIMA/SOF[IMA 35 Box of 30 ar 50 products RoIľUp drainable pouch Box oř 30 Or 50 products Box oř 10, 30 or 50 p rodu cts RoIľUp dra inable polich FLEXIMAJSOFTIMA 35 RoIItJp drainable pouch FLEXIMAISOFTIMA 35 RoII Up drainable pouch XX FLEXIMA/SOFTIMA3S XY RoIľUp drainable pouch FLEXIMA/SOFIIMA 35 Box oř 30 ar 50 products RoII Up drainable pouch FLEXIMAJSOFTIMA 35 RoIľUp drainable pouch Box oř 10, 30 Oť 50 products XX FLEXI MA/SOFĺIMA XY RoIľUp drainable pouch FLEXIMA/S0FrIMA 35 RoIľUp drainable pouch MIDI Beige 55 Beige 65 Beige 80 Transparent 45 Transparent 55 Transparent 65 Bege 45 Beige 55 Beige FLEXIMA/SOFIIMA 35 Box of 30 ar 50 products Roll Up drainable pouch Beige MINI FLEXIMA/soFrlMA3s Box of 30 ar 50 products Roll Up dramablepouch Beige 55 3/4 I
6 . Beige. I Transparent 55 CODE/ PACKAGING FLEXIMAJSOFTIMA 35 RES DESIGNATION COLOUR (mm) Table 4: Flexima/Softima 3S High flow drainable pouches 4/4 o/o\2ü 3 Signature Date Regulatory Affars Name: Isabelle DESPLAT products L Box oř 10, 30 or XY XX High Flow clrainable pouch Box oř 30 or 50 prociucts FLEXlMA/S0FIMA 35 80H FLEXIMA/SOFflMA 35 Hiqh Flow drairiable pouc! i High Flow drainable pouch 55 Beige products XX FLEXIMAJSOFTIMA3S XY High Flow drainable pouch High Flow drainable pouch Transparent FLEXIMAJSOF11MA3S l-iigh Flow dra inable pouch Box oř 10, 30 or 50 Transparent 80 EC Declaration of_conformity BBRAUN 204, avenue du Maréchal Juin F Bouiogne Cedex B.Braun Medical S.A.S.
7 vyhlasujeme na našu výhradnú zodpovednosť, že skupina produktov:. i c ooo ( AlE J200 A 70i JouIcrn [ec llx0 4 II) J 99 Lhofto,rc Pharntutqu tc pr Act n5 S p)f 5rer t2 05C F6E 2U4 flhi dli ariih,i u n In. I e SDclaI zodpovedajúcich priloženému zoznamu produktov, sú zdravotnícke pomócky triedy I. Regulačné záležitosti Kvalita a regulačné záležitosti pomócok nesterilných triedy I BBM F-M-S-l-al-O 12-1-D-EN Revízia: 03. júna 2013 PODLOŽKA A UZAVRETÉ ALEBO VÝPUSTNÉ ALEBO VYSOKOPRIETOKOVÉ VRECKO FLEXIMA/SOFTIMA 3S My, spoločnosť B. Braun Medical, 204, avenue du Maréchal Juin, Boulogne Cedex, Francúzsko, Podľa prílohy VII smernice 93/42/EHS o zdravotníckych pomůckach ES Vyhlásenie o zhode B B B. Braun Medical S.A.S. Prvé vydanie: 17. decembra 2012 Preklad z anglického jazyka 204, avenue du Maréchal Juin Okrem toho, potvrdzujeme, že hore uvedená skupina produktov spíňa všetky požiadavky SMERNICE Podpis: podpis nečitateľný Podpis: podpis nečitateľný 93/42/EHS o zdravotníckych pomóckach, ktoré pre ňu platia. Meno: Isabelle DESPLAT Meno: Ludovic ETCHEVERRY Dátum: Dátum: Vyhlásenie ES o zhode zdravotníckych F Boulogne Cedex
8 Preklad z anglického jazyka B. BRAUN B. Braun Medical S.A.S. 204, avenue du Maréchai Juin F Boulogne Cedex ES Vyhlásenie o zhode ZOZNAM VÝROBKOV SORTIMENT FLEXIMA/SOFTIMA 3S podložka a uzavreté, výpustné alebo vysokoprietokové vrecko. Trieda Sterilné/Nesterilné Uvažované použitie Kód GMDN Nesterilné Dvojdielny zberný systém pre pacientov, ktorí sa podrobili enterostómii (Uzavreté vrecká (Výpustné vrecká) POPIS VÝROBO K Pozn priložený zoznam výrobkov. Dátum prvého označenia ES (alebo číslo prvej šarže): 17. december 2012 Regulačné záležitosti Meno: Isabelle DESPLAT Kvalita a regulačné záležitosti Meno: Ludovic ETCHEVERRY Dátum: Dátum: Podpis: podpis nečitatefný Podpis: podpis nečitateľný Prvé vydanie: 17. decembra 2012 Revĺzia: 03. júna 2013 Vyhlásenie ES o zhode zdravotníckych pomöcok -zoznam výrobkov BBM F-M D-EN Lubo,atoi,c Pha,mcutqu rcc tr par Act.on S rplrf Čr u CJlrlti tr 311)00000 tc rrrrr 52 (iso S0 Sire APE JzsrJ A Sieqr Sociij )L4, aeeflue du Muruh,i tu 1 Ji uouic2 e C( IrI rua0i 4 u 51 CU 1Ub39
9 XX FLEXIMA/SOFTIMA 3S O 45 Kód/Balenie Špeciálne označenie Použitie O (mm) O 45/ O 45/ FLEXIMA/SOFTIMA 3S O 45/ XX O 55 Škatul a s 5 alebo 10 Podložka Škatuľa s 5 alebo XY Podložka Podložka a uzavreté alebo výpustné alebo vysokoprietokové vrecko Tabuľka 1: Flexima/Softima 3S podložky FLEXIMA/SOFTIMA 3S ES Vyhlásenie o zhode F Boulogne Cedex B BRAIJ N 204, avenue du Maréchal Juin B. Braun Medical S.A.S. Preklad z anglického jazyka Škatuťa s 5 alebo 10 Podložka O 55/ XX O 65 výrobkam I FLEXIMA/SOFTIMA 3S O 5 5/ FLEXIMA/SOFTIMA 3S O 65/40 výrobkam výrobkam Škatuľa s 5 alebo 10 Podložka Škatuľa s 5 alebo XY Podložka I 5-40 Škatuľa s 5 alebo 10 Podložka Škatuľa s 5 alebo 10 Podložka 1/ XX FLEXI MA/SOFTIMA 35 O 80 Škatuľa s 5 alebo XY Podložka Škatuľa s 5 alebo 10 Podložka Škatuľa s 5 alebo XY Podložka 15-65
10 2/4 Škatul a s 30 alebo 50 Uzavreté vrecko Škatul a s 30 alebo 50 Uzavreté vrecko Škatul a s 10, 30 alebo XY Uzavreté vrecko Škatul a s 30 alebo 50 Uzavreté vrecko FLEXIMA/SOFTIMA 3S Priesvitná Priesvitná Priesvitná Béžová 45 označenie vrecka Kód/Balenie Špeciálne Použitie Rozmer Farba O(m FLEXIMA/SOFTIMA 3S Priesvitná FLEXIMA/SOFTIMA 3S Béžová FLEXIMA/SOFTIMA 3S Béžová Béžová Priesvtná Priesvitná Priesvitná 65 Škatura s 30 alebo 50 Uzavreté vrecko Béžová XX Béžová XX Béžová FLEXIMA/SOFTIMA 3S Béžová 4! MINI Béžová 5! Tabulka 2: Flexima/Softima 3S uzavreté vrecká ES Vyhlásenie o zhode B BRAIJ N 204, avenue du Maréchaj Juin B. Braun Medical SA.S. Preklad z anglického jazyka Uzavreté vrecko Uzavreté vrecko F Boulogne Cedex Uzavreté vrecko MAXI Uzavreté vrecko Uzavreté vrecko Uzavreté vrecko Uzavreté vrecko Uzavreté vrecko MIDI Uzavreté vrecko Škatuľa s 10, 30 alebo XY Uzavreté vrecko Uzavreté vrecko
11 Preklad z anglického jazyka B BRAUN B. Braun Medical S.A.S. 204, avenue du Maréchal iuin F Boulogne Cedex ES Vyhlásenie o zhode Tabul ka 3 : Flexima/Softima 35 výpustné vrecká Roll-Up Kód/Balenie Špeciálne Použitie Rozmer Farba O (m označenie vrecka Priesvitná Priesvitná Priesvitná FLEXIMA/SOFTIMA 3S Priesvitná 80 Škatul a s 30 alebo 50 MAXI Béžová FLEXIMA/SOFTIMA 3S Béžová Béžová Béžová Priesvitná 45 Škatura s 30 alebo XX Priesvitná 55 Škatuľa s 10, 30 atebo XY MlDl Priesvitná Béžová XX Béžová 55 Škatuľa s 10, 30 alebo XY Béžová Béžová 45 škatuya s 30 alebo FLEXIMA/SOFTIMA3S MINI Béžová 55 škatuľa s 30 alebo 50 Í 3/4
12 Preklad z anglického jazyka B BRAUN B. Braun Medical S.A.S. 204, avenue du Maréchat Juin F Boulogne CecleX ES Vyhlásenie o zhode Tabuľka 4: Flexima/Softima 3S vysokoprietokové výpustné vrecká ) Kód/Balenie Špeciálne Použitie Farba O (mm) označenie Priesvitná 55 Vysokoprietokové výpustné vrecko Priesvitná 65 Vysokoprietokové výpustné vrecko XX Priesvitná 80 Škatuľa s 10, 30 alebo XY Vysokoprietokové výpustné vrecko FLEXIMA/SOFTIMA 3S Béžová 55 Vysokoprietokové výpustné vrecko Béžová 65 Vysokoprietokové výpustné vrecko XX FLEXI MA/SOFTIMA 35 Béžová 80 Škatuľa s 10, 30 alebo XY Vysokoprietokové výpustné vrecko Dátum Regulačné záležitosti Meno: Isabelle DESPLAT Podpis: podpis nečitateľný 4/4
13 Tlmočnícka doložka Sworn Translator s Certificate Ako súdna tlmočníčka slovenského As a sworn translator of the Slovak jazyka menovaná dekrétom ministra language appointed by the Minister of spravodlivosti Českej republiky Spr Justice of the Czech Republic by Spr 5 6/97 56/97 zo dňa 12. mája, 1997 týmto Decree dated May 12, 1997 I confirm potvrdzujem, že tento dokument je hereby that this document is a correct and presným a úplným prekladom do full translation into the Slovak language and slovenčiny a súhlasí doslovne so complies verbatim with the attached znenírn pripojenej listiny v anglickom document in English. This translation has jazyku. Tlmočnícky úkon bol riadne been duly entered into the journal under the zapísaný do dermíka ako položka č. 3 / t number Ing. Ingrid Mrázová
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