Dossier d`information Euro Pharmat
Contents
1. DECLARATION OF CONFORMITY We declare under our sole responsibility that the Medical Device Terumo Syringe without Needle m e SS 108 SS 208M SS 05L6 SS 1086 S 20ES 5890176 _ SS 05LM_ _ SS 10ES _ SE 0 6 SS 03L 55 055 SS 10ESM _ 20ES1 5 0311 5540556 8 20L S420ESM S8403LM SS 10L SS420LI Es SS403L6 SS 10L1 SS 20LN S84038 SS 10L6 SS420LM 550356 SS IOLM 554208 SS 05L _ 55 011 SS 01H1 Class Ha Rule 2 Annex IX MDD _ meets all the provisions of the Directive 93 42 EEC as amended which apply to it 556 1 2001 T50 10993 11 2006 150 14971 2009 150 7886 2 1996 980 2008 180 7886 1 1993 1 1995 EN 1041 2008 standards national EN ISO 11607 12009 standards or other normative documents ISO 14644 11909 ISO 594 1 1986 EN ISO 10993 1 2009 ISO 11737 1 2006 ISO 10993 42002 Amd 1 2006 ISO 11737 2 2009 TSO 10993 5 2009 ISO 8537 2007 190109983 10 20 LI Conformity Assessment Procedure Terumo Syringe rew 16 POB 85003 FT euro pharmat Seringues trois pi ces 15 21 lt gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL rm a TUV Rheinland LGA Products GmbH Registration No DD2. greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL SERINGUES TROIS PI ECES i Renseignements administratifs concernant l entreprise Date de mise jour Septembre 2011 Nom TERUMO France Adresse compl te Tel 01 30 96 13 00 Fax 01 30 43 60 85 Bat Uranus e mail terumo france terumo europe Rue H lene Boucher 1 Parc Ariane Site internet www terumo europe com 78284 Guyancourt Cedex Coordonn es du correspondant Tel 01 30 96 13 03 mat riovigilance Fax 01 30 43 60 85 S bastien RENARD e mail sebastien renard terumo europe com Informations sur le dispositif ou quipement o Denomination commune selon la nomenclature d Europharmat Seringue 2 2 D nomination commerciale Seringue trois pieces eee D nomination commerciale Seringue trois pieces Code nomenclature Code GMDN 13940 Code CLADIMED Code LPP Non applicable liste des produits et prestations remboursables inscrits sur la liste pr vue l article L 165 1 Classe du DM lla Directive de l UE applicable 93 42 r vis e 2007 47 Selon Annexe n 11 et V Num ro de l organisme notifi CE 0197 T V Rheinland Cologne Allemagne Date de premiere mise sur le march dans l UE Avant 1998 Fabricant du DM Terumo Belgique Terumo J apon Terumo Philippines Descriptif du dispositif avec photo sch ma dimensions volume Seringues trois pi ces st riles Seringue destin e
3. ex F 5 m TUVRheinland TUV Rheinland Boc oe ums v LGA Products GmbH Tillystra amp e 2 90431 N rnberg Attachment to Registration No DD 60038153 0001 Report No 60013826 003 Manufacturer Terumo Philippines Corporation 124 Esst Main Avenue Laguna Technopark Binan Laguna Philippines Scope FL peo I LACCUrTE NCS wi Ll Lied 1 1 Syringes wich eec Uri nary Bags Date 08 03 2011 FT euro pharmat Seringues trois pi ces 13 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ia a TUVRheiniand TUV Rheinland Doc 1 2 Rev 0 LGA Products GmbH Tillystra amp e 2 90431 N rnberg Attachment to Registration No DD 60038153 0001 Report 60013826 003 Manufacturer Terumo Philippines Corporation 124 East Main Avenue Laguna Technopark Binan Laguna Philippines Scope Produc Byringes with Needle Intravenous Catheter 7 1 LCD sal l l 1 Jup i T T Le ibn Ba bk uh als um acht 4 Rr hd a tA Irradiation using Electron Beam Date 08 03 2011 FT euro pharmat Seringues trois pi ces 14 21 lt gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ANNEXE 4 1 TERUMO TERUMO PHILIPPINES CORPORATION 124 East Main Ave Laguna Technopark Bi an Laguna Philippines Tel No 049 541 2111 Fax No 049 541 2121
4. l injection de m dicaments imm diatement apr s leur pr paration nsertion photos reli au point 9 FT euro pharmat Seringues trois pi ces 1 21 lt gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL Tableau des r f rences R f rences Volume Description Nbre Nbre Unit boite unit carton 85501 1 Embout centr 1800 255025 2 5ml Emboutcentr 100 1200 1 S05SE1 5 Embout centr 100 1600 25510 5 10 Embout excentr 100 500 8SS20ES1 20 Embout excentr 50 600 1SS30ESE1 30 Embout excentr 50 400 2BSSOES 50 Embout excentr 25 100 seringue tuberculine seringue insuline Conditionnement Emballages UCD Unit de commande 25 50 ou 100 seringues selon le volume CDT Multiple de l UCD Quantit variable selon le volume voir tableau ci dessus QML Quantit minimale de livraison Le carton Code barres EAN Descriptif de la r f rence POSITIONS REFERENCES EXPLICATIONS 1 1 2 8 Lieu de fabrication 15 apon 2 Belgique et 8 Philippines lt 55 85 01 02 05 10 Volume en ml 0121ml 02 2 4 5 20 30 50 055ml 10 10mI 20220ml 30230ml 50 50ml T Tuberculine nsuline T S C ES C Embout cath ter ES Embout excentr S Embout centr Eloul St rilisation aux rayons p Etiquetage Voir ANNEXES FT euro pharmat Seri
5. FT euro pharmat Seringues trois pi ces 21 21
6. T i d REP TEMLUMLO EUROPE N V e 40 3001 LEUVEN 2 ES T SEH50I3001L TERUMO SYRINGE 2 SERINGUE SPRITZE JERINGA SIRINGA SPUIT SPRUTA LATEX FREE SANS LATEX LATEXFREI SIN LATEX ER PRIVA DI LATTICE LATEX VRN LATEX FRI DE FT euro pharmat Seringues trois pi ces 5 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ANNEXE 3 APPROVAL T VRheinland EC Directive 93 42 EEC Annex ll Article Full Quality Assurance System Medical Devices Registration No HD 60035711 0007 Report No 21150638 001 Manufacturer TERUMO EUROPE N V Interleuvenlaan 40 3001 Leuven Belgium Scope Desian Development and Manufacturing of Medical Devices 1 lucts and additional sites included Date of Expiry 7 12 201 The Motified Body hereby authorizes the quality management system established and applied by the Date _ 08 12 2010 T V Rheinland LGA Products GmbH Tillystra amp e 2 90431 N rnberg Accredited by Zentralstelle der L nder f r Sicherheitstechnik 215 and Zentralstelle der Lander f r Gesundheitsschutz bei Arzneimitteln und Medizinprodukten 216 Notified under No O197 to the EC Commission The CE marking may be used if relevant and effective EC Directives are complied with C we mme ame 2 2 ew X M FT euro pharmat S
7. Corporation 44 1 2 choma Hatagaya SHIBUY A KU TOKYO 151 0072 JAPAN Scopa Products included ExtEa corpotraeal Mem Cmrdicpnpulmnemnairy Bypass Arterial Line Bl Filters Heart Lung Bypass Cardiotomy Reservoil Cardicmrimensry Bypass Blood Reserroit na El IS eh mi ri LL E TIME Loe Ce Catheter Guide Wire Guiding Catheter Catheter Introducer Stents Epidural Anesthesia Kit Extengion Tube Temperature Control Unit for Heart Lung Bypass Module Infusion Pump Syringe Infusion Punp Clinical Electronic Thermemeter Clinical Eiectronic Blood Pressure Monitar Endoscopic Electromechanical Burgi B To d FT euro pharmat Seringues trois pi ces 19 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ANNEXE 5 1 Rev 05 We TERUMO CORPORATION 44 1 2 chome Hatagaya Shibuya ku Tokyo 151 0072 Japan being the manufacturer of TERUMO Syringe Product Syringe declare that the above products of Class are in conformity with the provisions of Annex and Annex II of the EC Council Directive 93 42 EEC of 14 June 1993 as amended concerning medical devices and have been subject to the conformity assessment procedure laid down in Article 11 3 a of the Directive relating to the Full quality assurance set out in
8. Notified Body 60038153 0001 authorized by the German Competent Authority and carrying the Motified Body No 0197 Manager Quality Assurance Place Date of Issuance Terumo Syringe rey 16 POB 55003 FT euro pharmat Seringues trois pi ces 16 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ANNEXE 5 APPROVAL TUVRheinland EC Directive 93 42 EEC Annex Il Article 3 Full Quality Assurance System Medical Devices Registration No HD 60026344 0001 Report Mo 12018114 001 Manufacturer Terumo Corporation 44 1 2 chome Hatagaya SHIBUYA KU TOKYO 151 0072 JAPAN Scope Design LDewelopment and Manufacture of Medical Devices ee attachement for producta included Replaces Iprag 1 1 li HI 001 001 Date of Expiry 2 08 2014 The Notified Body hereby authorizes the quality management system established and applied by the company mentioned above The requirements of Annex ii Ar cie 3 of the directive have been nei This approval is subject to periodic surveillance defined by Annex I Article B af the aforementioned EC Directive and can be used by the company with the manufacturer s declaration of conformity Cologne 07 09 2008 Wr Grauen Stein D 51105 K ln T V Rheinland Product Safety GmbH Accredited by Zentralstelle der L nder f r Sicherheltstechnik ZLS and Zentralstelle der Lander f r Gesundheitsschutz bei Arzneimitteln und Medizinprodukten 21 61 Noti
9. Warehouse operations of medical devices TERUMO UK 3 Unity Grove off School Lane Knowsley Industrial Park South Knowsley Merseyside L34 96T United Kingdom Scope Design development and manufacture of extracorporeal circuits for open heart surgery and ancillary circuits Date 08 12 2010 t RM H H FT euro pharmat Seringues trois pieces 8 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ANNEXE 3 1 DTERUMO Rev 19 P5 3009 DECLARATION OF CONFORMITY We TERUMO EUROPE N V Interleuvenlaan 40 3001 Leuven Belgium being the manufacturer of ppp a iem TERUMO SYRINGE WITHOUT NEEDLE TERUMO SYRINGE WITH NEEDLE Product Hypodermic Syringes for manual use eee Appendix A for related product codes declare that the above products of Class Ia are in conformity with the provisions of the EC Council Directive 93 42 EEC of 14 June 1993 as amended concerning medica devices and have been subject to the conformity assessment proc edure laid down in Article 11 2 and 11 3 of the Directive relating to the Full Quality Assurance System set out in Annex and by certification of Annex 11 3 under the supervision of TUV Rheinland LGA Products GmbH Registration No HD 6003371 0001 as Notified Body authorized by the German Competent Authority and carrying the Notified Body Na 0197 E MA A RTS Affairs
10. Lech Door an Lame Lee DO Sa Oe eS 9 M TE i Dr LATE G ae gem D eem Dese ge y pena Deam c pur lyr TM PS oer in d vir imm pario Ce LATE LATE FRE The Drogen dti L ONU LE nr Statue pa ic Le gn E pego v S C ALTERS Kk rol ona d ADS OU HORS AET Tas Ets Or ken PADCA Oi inr LE sa a coena n penocfto ann ST nan Sne dH gewi Tu ET NEEN Chae ay gie ott aser RO erd wl ture PLADE eect donc Face data cence inde deae mone maria ai pieh SC PET Ur Bun pr dire econ Ce prada sii OT STORE AT FREE Laag WR vn eg Gus HO ej DR F EXT TEMISERATUTRES AMO MCD msc AUS ERIC THE Fes Span LORITES Dart Op Cal PEL d get RW POR AEs nuer Dale reich spi aras metro fei wm ane Fan CONSEPVAHE A TTMPERATUPIE ECCESSIVE LOH UC CTE Tie oye Lacs Lc amus oe soi rt eel ad puc mere VENFONBONE ALLA EAR DIR TTA STUDIUMS Tw d PSECU TEE this Dan ee ee Lt FIER i Lois s Spee bel ego Ca ed ape ee ad Pe Un si ee ST KIT eee SP MTL TE Ris se De ST Ree ben ete erg tre Mage RAN pour eter be rte d V fer Cp pu Laer Prado de SVOOR OIGEALAA Hat Un er Tee d Ca arcum of ai D Tir TEEPEN T
11. TERUMO EUROPE N V Leuven 17 August 2011 place and date of issue FT euro pharmat Seringues trois pi ces 9 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL L c Rev 19 P5S 3008 GIL Le 30 n m RER Blister Syringes new design Production site Terumo Europe NV Sec item m ENS 1 mi Luer Item type cent er Luer Slip Tip Eccentr IC Step Tap Catheler fn 2 Bister Syringes Bie Ver Syri new design Terumo Europe NM E mi Liber Item type node T Tuberc ulin he g amp Center Luer 5l pip Cannula sine EF ecer 3 123606 2560 3 6 161258 s asmmsi a p EH 3 18 pommiin 23 euro pharmat Seringues trois pi ces 10 21 gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL L1 L 4 CDTERUMO Rev 19 PS 3009 S Blister Syringes neve design Terumo Europe E Product item o 2 zsm LS Item type amp Center Luer Slip Tip Cannula size 1 1 18 G 1 2 mim Cannula size 2 3 216 _ 0 8 mm Cannula size 3 736 0 5 mm 13 FT euro pharmat Seringues trois pi ces 11 21 gt greiner b
12. a validit du produit 5 ans Pr sence d indicateurs de temp rature s il y a lieu Non 5 S curit d utilisation S curit technique Fb S curit biologique s il y a lieu Non applicable 6 Conseils d utilisation 61 Mode d emploi OO 6 2 Indications O 6 3 Pr cautions d emploi Voir mentions jug es utiles ci dessus _________ 64 Contre Indications o O 7 Informations compl mentaires sur le produit Bibliographie rapport d essais cliniques ou d tudes pharmaco conomiques am lioration du service rendu recommandations particuli res d utilisation restrictions de prise en charge plateau technique qualification de l op rateur etc 8 Liste des annexes au dossier s il y a lieu Pr cautions d emploi sur la boite Annexe 1 Boite Annexes 2 Certificat de marquage CE Belgique d claration de conformit Annexe 3 et 3 1 Certificat de marquage CE Philippines d claration de conformit Annexe 4 et 4 1 Certificat de marquage CE J apon d claration de conformit Annexe 5 et 5 1 9 mages s il y a lieu Format gif jpeg png FT euro pharmat Seringues trois pi ces 4 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL PHARMAT ANNEXE 1 Pr cautions d emploi boite Shad pert a amo ae Praec a Ecc wu o mon Par eem ebore EVIL Lo LAP FREE LATED Diem 51 rar
13. amp nnex lL under the supervision of T V Rheinland LGA Products GmbH Registration No HD 60026344 0001 as Notified Body authorized by the German Competent Authority and carrying the Notified Body No 0197 Authorized European Representative ERUMO EUROPE N V Interleuvenlaan 40 3001 Leuven Belem Object of the declaration see appendix A Tokyo March 21 2010 P 8 place and date of issue Uefa eg Hiroshi Nakagomi General Manager Quality Assurance Department TERUMO CORPORATION D TERUMO Page 1 of 2 FT euro pharmat Seringues trois pi ces 20 21 gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL No DOC PQB TF SS Rev 05 Appendix A List of Code Number Structure 2 9 HM WM MH oe 1 2 3 4 7 5500000 1 d 3 4 5 eS H HDH DH H OO 1 2 3 4 5 D H 1 Product series product type one digit S Syringe 2 Destination Japan and overseas two digits i Japan Overseas 3 Nominal capacity product type two digits 02 2 5mL 10 10 20 20mL 30 30mL 50 50mL 4 Cylinder haad shape one two digits vi Slip tip EDO M a Round lack ES Cross slip lip Catheter lip 5 Others Z Gamma sterilization E Electron beam sterilization 6 Injection needle type four digits Upper two digits Needle gauge Lower two digits Needle length 7 Last digit 1 CE display 05 5ml D TERUMO
14. eringues trois pi ces 6 21 gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL E WW TUVRheinland OO T V Rheinland pets Sfr 9 LGA Products GmbH Tillystra amp e 2 90431 N rnberg Attachment to Registration No HD 60035711 0001 Report No 21150638 001 Manufacturer TERUMO EUROPE N V Interleuvenlaan 40 3001 Leuven Belgium Scope Products Syringes Needles b enti at Eh ygt amg EVETIC 1 0714 PILE for open heart surgery Angiographic intei Extra corporeal circuits Hon vascular quide wires Transfusion Systems For the following medical devices the scope covers only the aspects of manufacture concerned with securing and maintaining sterile conditions Ancillary devices for extracerporeal circuits for open heart surgery Blood collecting systema Syringes for oral enteral use Date 08 12 2010 FT euro pharmat Seringues trois pi ces 7 21 lt gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL TUVhRheinland T V Rheinland edes Spe News LGA Products GmbH Tillystra amp e 2 90431 M rnberg Attachment to Registration No HD 60035711 0001 Report No 21150638 001 Manufacturer TERUMO EUROPE N V Interleuvenlaan 40 3001 Leuven Belgium Scopa Bites included TERUMO EUROPE N W European Distribution Center Hrikkenovenstraat Ap LI p m e a E rte mon 7 1 row m
15. fied under No to the EC Commission The CE marking may be used if all relevant and effective EC Directives are complied ees ee ee eid NOR RE Lie A WE i mn mar FT euro pharmat Seringues trois pi ces 17 21 lt gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL TUVRhelniand T V Rheinland LGA Products GmbH TillystraBe 2 90431 N rnberg Attachment to Registration No HD 60026344 0001 Report Mo 12018114 003 Manufacturer Terumo Corporation 44 1 2 chomoe Hatagaya SHIBUYA KU TOKYO 151 0072 JAPAN Scope Products included Blood Bleed Donar Set fail Lc lLUransfuaton 21524 Transfusion Filter 1 ba i ni LI a oa Hypodermic Syringe Winged Needle Dental Needie Bpinal Needie Other Medical Needle Blood Administration Set Lancet Certification Edo Wi VK Ee i EI y p A 1 M EN d y pL 2 dk x B Dipl Ing D Meier FT euro pharmat Seringues trois pi ces 18 21 greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL S TUV Rheinland T V Rheinland Doc 2 2 Rev 1 LGA Products GmbH Tillystra amp e 2 90431 N rnberg Attachment to Registration No HD 60026344 0001 Report No 12018114 003 Manufacturer Terumo
16. io one Dossier d information Euro Pharmat DISPOSITIF MEDICAL ANNEXE 4 APPROVAL TUVRheinland EC Directive 93 42 EEC Annex V Article 3 Quality Assurance System Production Registration No DD 60038153 0001 u Report No 60013626 003 Manufacturer Terumo Philippines Corporation 124 East Main Avenue Laguna Technopark Binan Laguna Philippines Scope Manufacture of Disposable Sterile Medical Devices E ert Replaces Approval Registration DD 60029244 0001 Date of Expiry The Notified Body hereby authorizes the quality management system established and applied by the company mentioned above The requirements of Annex V Article 3 of the directive have been mot This approval is subject to periodic surveillance defined by Annex V Article 4 of the aforementioned EC Directive and can be used by the company with the manufacturer s declaration of conformity Date 08 03 2011 T V Rheinland LGA Products GmbH Tillystra amp e 2 90431 N rnberg Accredited by Zentralstella der Lander f r Sicherhaitstechnik ZLS and Zentralstelle der Lander f r Gesundheitsschutz bai Arzneimitteln und Medizinprodukten ZLG Notified under No 0197 to the EC Commission Ce The CE marking may be used if all relevant and effectiva EC Directivas are compliod with FT euro pharmat Seringues trois pi ces 12 21 gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL
17. ngues trois pi ces 2 21 Dossier d information Euro Pharmat DISPOSITIF MEDICAL Composition du dispositif et Accessoires pour chaque l ment ou composant pr cis polypropyl ne Polystyr ne Elastom re thermoplastique Lubrifiant Huile de silicone Pour les composants susceptibles d entrer en contact avec le patient et ou les produits administr s pr cisions compl mentaires v Absence de Latex Absence de produit d origine animale ou biologique v Absence de PVC Toutes mentions jug es utiles pour les pr cautions d utilisation V rifier l int grit du prot Strict usage unique gt Eliminer de fact Domaine Indications Domaine d utilisation selon liste Europharmat injection ndications selon liste Europharmat Injection ou pr l vement FT euro pharmat Seringues trois pi ces 3 21 lt gt greiner bio one Dossier d information Euro Pharmat DISPOSITIF MEDICAL 3 Proc d de st rilisation DM st rile OUI Mode de st rilisation du dispositif St rilis l Oxyde d thylene validation du process selon la norme EN 150 11135 1 2007 Pour r f rences avec un 1 ou un 8 st rilisation par rayonnement p selon la norme EN 150 11137 1 2006 11137 2 2007 4 Conditions de conservation et de stockage Conditions normales de conservation amp de stockage pr cautions particuli res Eviter le stockage des temp ratures excessives et l humidit Dur e de l
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