CERTYFIKAT WE / EC CERTIFICATE zgodny z 93/42/EWG Zatacznik Ilo. «)/ acc. 93/42/EEC Annex Ilw.c.4 Niniejszym zaswiadcza sig, 2e firma / This certifies, that the company Zaktad Produkcji Sprzetu Medycznego RAVIMED Sp. z 0.0. ul. Polna 54, PL / 05-119 Lajski dla kategorii wyrobéw steryinych klasy Ilb / forthe product category class lib in sterile condition (Lista wyrobéw patre zalacznik 1 / Lis of products see annex 1) Zestaw pojemnikéw do pobierania, przechowywania i preparatyki krwi. Containers for blood collection, storage and preparation. ‘stosue system zapevnienia jakoScl w projektowaniu, produ kontrol kofcows wymienionych wyrobow zgodny 2 vymaganiami Zalacrika (2 wjaczeniem sekc) 4) dyrektyy 93/42/EWG. Dodatkowo, pray aku CE mus zosaé naniesiony numer ientyfkacyjny jednosts notyfkowan \Wazno8é tego cetykatuzalezna jest od ulrzymania syslemu zapewnieniajakoéci zgodnego 2 wymagariami dyrektywy jogo nadzorowania przez Jest notyfkowana 2godnie z Zalgcznikiom Il, rozdzal 5. Ceryikat nie moze byé przenoszony pod zadnym warunkiem. ‘nas established 3 qualty system for design, production and fina esting acc. to the requirements of Annex Il (excluding eection 4) ofthe directive 93/42/EEC. Adddonal to the CE-marking the notifcation number ofthe Notiied Body has tobe axed. The vali ofthis certincate is based onthe ‘maintenance of the quay system in accordance withthe requirements ofthe directive and its surveliance by the Notited Body accoraing Annex I section 5. The ceticate may not be taneforred under any crcumstances. Ne raj. | Rog.-No. TNPIMOD/0242/4245/2018 Wazny od / Valid from 13-11-2018 Raport nr / Report No. PL4245/2018 Weény do/ Valid until 12-11-2024 (wae iia Juzwiak Katowice, 14-10-2018 “nostka Certyfikujaca Wyroby Medyczne / Chriicaton body for medical devices Jednostka notyfikowana Numer identyfikacyiny 2274 ‘Notified Body ID. No. 2274 TUV NORD Polska Sp.20.. ‘+48 32 786 46 46, Fax +48 52 786 46 01 Ul Mickiewicza 29 40-085 Katowice ‘wonwtunord pl, biuro@tuv-nord pt Dopuszcza sig kopiowania certyfikatu tylko w niezmienione| postaci. / Copies ofthis certificate only without changes.ZALACZNIK oe, s:o00125 1 ANNEX o.s ou 1015 do certyfikatu numer rejestracyjny / fo Certificate Registration No. TNP/MDD/0242/4245/2018 Raport nr / Report No.: PL4245/2018 Weazny od / Valid from 13-11-2018 Wazny do / Valid unt 12-11-2021 Typ Type \Wytoby / Products asa /ciass—UMONS RECO aj 4 Cyyanam Sai w 09% Cert Sas SOO} ml © a5 Container wan Sedum Cte 9% Sedum Cheri (10-00) RSSDeOOS Paprnie 4% Cine Soy 25050) et © aes Contanarwin 45 Sada Cs sin (20500 SSO TODO Popes etnran ACOA) (10-1000) a5 Contr w ACOA) solo (150-100 RORREZ Popa 12% rorwaren Chara Soar Sad ® 088 Contr wer ¥2 Sadun Gri salen 50 ORION E Poarein? 35% reawaren CHora Soar © 5 Contr wah 28% Sem Chai salstlon 500m RORETE Pojarene 18% anrem CHa Soar 30m © a5 Canter wah 65 Sam Chie salstlon 900m ROLORES "PjareR9evram CHork Soa (97) S00 mT © ‘area ‘Contin th 9% Sach Co selon.) 30 6 ORES Pajares 167 eran Cryer Soa SO cS ‘Contana it 47% Sodm Cre son ROTOR Pajares 1.75 ere Crna Soa 000TH © ras ‘Conte it 475% Sad Gate 1000 ROTI ajeiz pre Roden o wsohin size gia TOO © oma itso preserain ser ah ph eral concaaton 400m) RONG ajnni avi widen isin Seana pewats 20 ® ona nih bod presen nw ow ars conaraton 40.7 STOIC oj ane SAG T5100) ® 7085 tar SAGA sls (180000 mt ‘RSS aI er eo pea CPORT wb CPO [0 SV w 785 ‘Sag ta ah GEDA to CPD 160 80) mt ROS HO)S0-00}a er | Zs pod 2 CPA b CPD (b eOOEOSO) wt Boat Stnth CPD CHD on 50) mt 7s | SonTSS ARTE | wpa = CFO CPO SSA SS ANON RTT eas Giawe Tg am PDA er CPD SOIT E0 SONIDO ot | ercgosmarsonnrss | ase pra 7001 1 CPOE penne Go esroRaTS ARON TETRA a | Soceoeaser Pee oe esracaen 1 CPDL! f PO ih pat srage contin (150-00 55015080 TITSDSBOATEOITTTH— | Zw gos CEON CPO Hen Seay ancien su s0ON oem ebeoH a — | — S| ATES Soares itl sate CPOR CR uta (SOHN RD OBNT9D 00) md TTTsDAnOEOATOHT | Zw pov TOPO WB CPO jen So pacha PK Ke HEE GOTT? | Te] A766 Sobran one ‘soon (Seemnntan enn S00 Titi GPoa to CPS wh cnt aa ar recta e150. spline Samak Katowice, 14-10-2018 ‘panostka Cenyfkujaca Wyroby Medyczne / Eeriication body for medica devices Jednostka notyfikowana Numer identyfkacyiny 2274 Notified Body ID. No. 2274 TOV NORD Polska Sp. 200. {8 +48 32 706 40 40, Fax +48.32 786 4601 Ul Mickiewicza 20 40-085 Katowice ‘wor tu- nora pl, biuo@tuwnord pl Dopuszcza sig kopiowania certyikatu tylko w niezmienione| postaci./ Copies ofthis certificate only without changes.ZALACZNIMK «,s1000225 | ANNEX wo so0 2015 do certyfikatu numer rejestracyjny / fo Certificate Registration No.; TNP/MDD/0242/4245/2018 Raport nr/ Report No.: PL4245/2018 Wazny od / Valid from 13-11-2018 Wazny do/ Valid until 12-11-2021 Twi vyoby Process asa /ciaseUMONS as orem es RON EOSuTaS | Zw GRE CRON TEC IE EORTSESDHRE ara Sen Tip wih CASA SO TOS SOT IOSD SE SOTT RTT | Fa az OPOE jo Ree ARIE ea booKsar Feomoon staonntsnsonat ‘i tm CPD-SAG ptt sre con (5050/ 5600150 00.4 Rea Say Zea py zCPG SAGA rem cei oro SOE IN STAT areas itsaaoocone ‘of Po. aay 5040912060 2000 Soames SPOS penton moana ia eo SF oe smcsnet ‘Sacre (ooo eant so snorm Fee ein: tg cre artnet con 600 TILRDSDONTEOSOTT | tet gory Ove Dr CPOSAGH OR AOA SOARO RT 785 bois ‘ie Top ton nn CPO SHON uD OID Coat FIT DUDOTEOIOHTI. | Zan 9 Ge CPO“SAGHE io 5 eH Son SOTA TSH | 885 ‘Pores fom Til op Son lt CPD SAGL wh cng ron 5 S005 HERONTDGDONTO- | et goenry ECPORT ut C°0 S840) Soa aD. 40 ares) Sonisoaeanoere ‘tmape tw DA o C0 50 ana e050 $00 exisoz60n sees | Zsa 2 CPORT ub CO pm chow Ew CHOSONTSO! | 1B} — a0 Seisoocerancrce | papeont So ators rant th Dt CPD wth pe stage ti (80 40 TSO OD EERO RESON] Sete cre x DT wR CPO i WH WG TSO RDOTSOSOOTET a8 600) 150-800}CaL lublar CL |800)(150-600}m1 “ | Sterne tn cost cro man mein 0 HOH HOA HO BOER SOROITSE. | Seri aco CFD wR CPO = in chen KENT HER > | ar885 Scoisosnocerciuercr | reas ecpan icoanmcoount son oo aiora Sterns crane mn pt one sno reton (150- Sa Stn Sn. TOTO SONS [eet perry £oPU aca Se RE ORT RETRO Bares ontsoono con Bent ih PD nC an Oh 6a Uae | [ ERO aesDOTse —| Zw een xCPOSRGNTz aia rec A TODD oe anisowconr Say teennitasore Sete th Cu pi stron 80D SORES SSO mo) Sei x ODN Wi oT ATO SE ROT ED ATONTEE— | 5 | TB ap st wth CPO SAGM i hoy aca (80402504010 Wasa Katowice, 14-10-2018 Hesnestka Certyikujaca Wyroby Medyczne / (Fentcaton body fr medical devices ‘Jodnostka notyfikowana Numer identyfikacyiny 2274 ‘Notified Body ID. No. 2274 TUV NORD Polska Sp. 20.0. ‘8 +48 32 786 46 46, Fax +48 32 786.4601 UL Mickiowicza 29 40-085 Katowice wiv. tuv-nord pl, biurog@tuv-nord.p Dopuszcza sig kopiowania certyfikatu tylko w niezmienione| postaci. / Copies ofthis certificate only without changes.ZALACZNIMK oe, srom 325 ANNEX 1.1.s003015 do certyfikatu numer rejestracyiny / to Certificate Registration No.: TNP/MDD/0242/4245/2018 Raport nr Report No. PL4245/2018 Weazny od / Valid from 13-11-2018 Weeny do/ Valid until 12-11-2021 pType Wyoby Produets Kiasa/ciass MONS [ REx: sO Gow(s0- | arin pawn = GPOSAGM zoom do paschomyeta Pek wiv Go Teak] Te ‘aaa soo e0a00}eSneL icckovew (0400) 50601 5030115000) ‘Sie sown CPSAGU wih stage cantar anise edton (80- | ‘Snopieo evo 50e00(150 cla so-soD-eRD. | Zeit pach 2 CPO! bb CPO STROM STAD SOND ANTED TAT ® ony rac ano TSO Nca loc | ume et win CFDA GPO (Yo0c00 90600 8 B00 ADE DEO) SIs) 159<00)(s0- | Zevaw psotony _CPORT UB CPO Zpemaon de praachowvans PGR TOOSIORTSO. |W SION TECSeONTSOSO}CSP hater | 0st nO) tbea0/ 50cm & | Gums ser ms CPO or CHD wh petal tage contr 5050150500505 50- ‘toyreo. ero zs RSiSOOHNC TD SOONED———| Besta peseteg = CPONT CPO FE re TT TKN (CORO ROTO IS © 75 oon rscecoysoecjeat weer | 00) San) 68600 e Site CFO or CPO wa ken ter (5042015040 504015. | STS; TEDNOWTED. | esa pesokcny x CPO ub CPD x pomaion a paschouyeais BER a TAFE SS = are Soon race00yrsoc0c=e | recut iaocpow (130 S00) 5060015060015. 60050 Oye wasorcit ‘Gane st mn CPO4t a CPO wah lle ata conta’ ace reducton Ma (8- zoo. co 150.60) 150-00(19 oi TS s-SOyCTDRMONTEO- | Zesaw econo x COD-SACU | 5-0) SOO DADO TL ALOHA ATT @ 7085 oo rsceoytiseso0]sm | Gunaple set mn COP. SAGY 60 00/20 60700 8016060016.) ‘aio sn) 1sb=00,(e0- | Zstaw pecnohy zCPD-SRGH x aetna da BERS PAR Hoe [HOSTS © Te oorsceoytisesocsme | sooysc soa ts0 sox 50 cOOea ‘ui sa mt CPD-SAG wen plat serge conane(18-500//150800/150600/150. 2 sree eee —| recap aR SEE} eee cam | 2 eee nee pane emcee —— tere meena | — | foovrsbamisaacojcsnet, | amt (10-000 t0-s0) 10 Sony S800) e0 600% ‘Strum set wn cho. SAGU wiht strap onan andleocye resin ta (60- ‘onset ap e0 20 50600755600 TS SSESESSIS | et sty SPY ee 0 TATRA ESTO TTT soamsoauisa | om ‘Sojcanare wih CFDA.) CFD (8 600 15000115060 60 SDD SO. ‘Rave spAONT=D- | Zest sotcatony £ CPO ub PD x ajalon Go pachowyara Pak Ko (RE SEONTSO™ |B Sooiessoontcosunniso. | ons snot anos co en} isotope Solarian ce ‘Sects mh CFDA ar CD wan plate ere conn 150-50) 0600/1 SBADONS- acoso sooo ‘RI c-SpTSOaRONT- | ania eesotny «GEOR CFO Bor oe Nn TEOSTTSO ROT ® 75 fcojcachberte | Sean ete Choa: or 0 wn han eon ar (150 $05 606060015 eco sto soci SEO aUKT=D=OW HD. | Zara eesotery # COOK LBOPD = jonaion de pew GOT Ta ® aS eaONTBDEnONTSOCOON TSO. | redkel ocjow (10 SI0) 50 E00) 50 e018) 150:00) 10 ae ‘isk Katowice, 14-10-2018 4 “Sfonsta Cryfiace Vyoby Medyane/ brtication body fr mode devices Jednostka notyfikowana Numer identyfikacyiny 2274 Notified Body ID. No. 2274 ‘TOV NORD Polska Sp. z0.0. ‘ +48 92 780 46 40, Fax +48 32 786.4601 ul Mickiewicza 29 40-085 Katowice ‘www tuv-nard pl, biuro@tuv-nord.p Dopuszeza sie opiowania certyfikatu tylko w niezmienionej postaci./ Copies ofthis certificate only without changes.ZALACZNIK oe, sro425 | ANNEX o.1 s0040r5 do certyfikatu numer rejestracyjny / to Certificate Registration No.: TNP/MDD/0242/4245/2018 Raport nr Report No. PL4245/2018 Weaeny od / Valid from 13-11-2018 Weeny do / Valid until 12-11-2021 este Wyroby Products lass cass UMONS [eoorsPC Rare — ‘See sl ih CROAT 9 CPD wih lal Se li i is ASN ED {0/80 B00 50S00/750.6001 1508010 800i ‘RSUIsDODyTT=OMDDYED. | Zen estos = CPO SAG (15 00) 150 520} TED BOW TED ROWTEO OOH SO SOORT © aaa SRovsoeovisetn te. | Seen an mm Gro. SAGM (8001560190450 80 Oh 0015804 (EG GOO TaD ROW. | Zesiny satan 2 CPO-SAGN pjenniem do praionpwaria TSO] ——T ara Brow reDenoytsOs00K SO. | Gnysteoo, et sa0/ coco ech KS Eeecaia octet ots cna 240 040/121 ‘ACEDRON ID RTONTSD. | Zest aesaany «CPD SKE Wren STORRS ROGHEN COCOA ROOM TOO TOHTSE |B areas Sales RENTS | ae ca wth CoD SXGM moose recto Mr (1580018060150 60150. | storseosr so Baar, Faiie000)( 1 e050. | Zev sexs « CPD-SAGH poo do sehonywai Ka Aon eee | —— TB 7885 oojsoemnTcecoIGo- | iesorwt 5OSIOH gOS SO cOO aL eEON ORIN oc foojeane ‘Seco st CPO SAG wer pro stroge conser and eho relent (150. ects to So-co0 30 S00 20013 ant aRGeE ONT RAOWTID ——| Zest sama = CPORI WS OPD (S080 OT SORA SOTOOA TTI ® T7885 Sconspamoyisocnnico. | arotisostne Seoptisaca er Sept dt nth CPOA- er CPO 150600150 800150 0011506015 801504001150 ain | EIIGED On ROOD. | ent smaribray = CPD OPO = pion a5 PERO Rk (BO HOHTSO “7085 tonpsonnnrsnscoytsn- | Sonrtsncoyenacoy so au0M 0.0m 50 600m SSonsbamjapuercr | Senna Gn wc wt rt oe cme (80-401 E0 <0 | amen SoaTerarames ——| SISO 605001 ee raantaeaona TIED eR ATOVTS. | Zest seamirty «CPR CPD x Hier BoB OGRSH TORINO TOT © a7e88 Suontsosnprisnacoyisn- | earisooonantooytseedon (90 c00 Stoyso-sooycar ule’ | Sep ot wih DAT or CAO mn cc redcton Mer (50-600 001504001150 ‘bye son S0 800) 50.500 ‘RITR-eooN a HD- | Zag siony 2 CPOR-T ub CPD 2 opmaian a eaeouwata PRE eA REET TS ® a5 SooyiepapoyrisosoN igo. | reac} ake 0 0080 G00)156 eo0M 50 COOH 150.600) 150600 15004 SoyeoapoycaPt unter CPL | Sepuplasa wip CPOR CPD ih ate! tarage coma arse rekon e150. toys abdy50 800 60 coo 50.6001 5060050 diy a a _ eee, [ee See Soe eee eerataceatieomieenariteat | spite —| exer ae nese pasoeoe serum —|— Te} Sismesere | Ramet ee ee creams oa cmmn SL ae ee eels ea, coaster eae See a at PS dubwiak Katowice, 14-10-2018 Fees a vente ere @entification body for medical devices Jednostka notyfikowana Numer identyfikacyjny 2274 Nee ay sae TUV NORD Polska Sp. z 0.0. ‘@ +48 32 786 46 46, Fax +48 32 786 4601 Aca eee ones eee are ent Dopuszcza sie kopiowania certyfikatu tylko w niezmienionej postaci./ Copies ofthis certificate only without changes.ZALACZNIK oe, s:o00525 1 ANNEX so.s o00 5015 do certyfikatu numer rejestracyjny / fo Certificate Registration No.; TNP/MDD/0242/4245/2018 Raport nr / Report No. PL4245/2018 Weazny od / Valid from 13-11-2018 Wazny do/ Vatid unt) 12-11-2021 Typ/Typ0 wyoby /Produes asa /ciassUMONS 5 ‘OF DOT. BOOTIE. = ‘iso so) OWED. | Za seers = CPD-SAGIT = paolo aR AK ak EEG GT © “75 Boon rso coo 0-c00150- | ios 00} soa00/ 50 ee 500) 15-80) 15-00) 0 At OH s060}¢me Sept se in CPD.SAG wih lt! Seago Coane arg nlzyt aor fe (150. ena c00 5020150600 S000 00 DD I TSOSOOHSOBOOHTED: | Zestaw do poo plasalrery z CPO 6000/1600) 150 SY SD DO 7008 foontsoone ‘Dol asmaphees set wth CPO (1800/50 00/5080) 15060 PRO TTT en nea ewer TORR OPO =< a7 DONTE Zasan 5 dy paras wal tone] CPORT UB CPD a) 785 ‘ype 8 sth aco ood clean wih GPOAL CPO ROTO ajar rsivaran VES de labore] wepaata be 20-1 © a5 [Conti ith HES sson fr bray Eb reparation (20 750)m FTE{ISG- OOH ISO-S00/IEO'00) | Zesaw psc pony do podria i na suowce ISOS ISD-SOAC TD DIT © Tae “Tl sy sta od aso rain si (7 600,150 600) 1500) RSTO TONY Zesaw pre arferowch pjdezy 50-1000) m0 © ‘ara ‘Stage rater bags st (507000 STOO a lr se para 10) ae Pasa PSE cS ‘Shag raster bogs a (501000) et SOT See ee w ‘Sing vaste set wih acai rdin er 8000) 01 ROTA DOTS RIOT Zastow paenkw arta nay TETEDOWTSO CORT ® a8 Beant Fans bgs oe (150.30)10 004 | RTTs0 50; Sn) TD RIO) | Zest aaa ar pas SOTO THORN TNT © ae ‘ere os st (0 000 00150000 ‘Rly SOs TOOOHLTED- | Zestw oj Fareerwychpowdry (1 ye sOOHTSDSOORISO SOOT © TES oon soo) cre art bge so 50.600 S060 SOOO S800) STH iso-Soy(1SD-ODHTEO- | Za ppm Pnaeraweh pierOyHE OH TSO COOH SRO SOSH TOT © a5 SOOM Iso-eoyt 0-00) ‘inte rant gs so (0-0 1480050600! 150S00 150.600 woh Jednostka Certyfikuigca Wyroby Medyczne / ertification body for medical devices Jednostka notyfikowana Numer identyfikacyjny 2274 ‘Notified Body ID. No. 2274 Katowice, 14-10-2018 TOV NORD Polska Sp. 20.0. |B 448.92 786 46 46, Fax +48 32 786 4601 Ul Mickiewicza 28 40-085 Katowice ‘www tuv-norpl, biuro@tuv-nord.p Dopuszcza sie Kopiowania certyikatutyko w niezmienione| postaci./ Copies ofthis certificate only without changes.