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,' ,' OPFAH 3 OqlHKt/'l BlflnOBlflHOCTlTOB. <r,4O CnaEHnn M EA n r{ H yl t4 qE HTp c E pTyt o I KALI|T)
' ' tdennufi,ixa4iduud HoMep npu3Ha.teHoeo opeaHy IJA.TR.126
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CHIRANA T. Injecta, a.s.Nim. Dr. A. Schweitzeral94, Stari Tur6,916 01,Slovak Republic
Tonapucrno : o6uexenoro siAnoniAamnicrro''MEPKYPI}I BECT'' ILLC UMERCURY II/EST"ropr{A}rqHa alpeca/ Legal address:79011, Yrpaina, u. Jlrnin, nyn. I. Opanr<a, 107177901I, Ulvaine, Lviv, 107/7 Ivana Franka str.
Qaxruuua agpeca/Location address :
79057, Yrpaina, u. Jlrnin, nyn. Anrononn.ra, 12879057, Ulcraine, Lviv, 128 Antonovich str.79037, Yrpaina, u. Jlrrin, nyn. 9zrzpuycrxa,4279037, Ulcraine, Lviv, 42 Chygtrynaskn str.Ter.: +38 032 244 244 0, [email protected]
Crepn.nrni preAu.rrri nupo6u oAlropa3oBoroBrrKoprrcr alnssl St er il e di s p o s ab I e me di c al dev i c e s
flepenir Me,{HrrHr,rx nupo6in 3a3HarreHr4fi y ,{o4atry J\b 1 m,{o4arry 3, ruo e neni4'eMHr.rM}r rracrr{HztMr{ rlboroCepru([ircary si.uuoeiAHoqilThe list of medical devicesindicated in Annex I and Annex 3 which is the integral partsof the Certificate of ConformityTexniqnoro peuraMeHTy IrIoAo MeAI{qHEx nnpo6in(sarnep4xenzfi floctaHoBoro KMy sfu 02 xonrns 2013poKy Ne7S3)lTechnical regulation on medical devices(approved by Deuees of Cabinet of Ministers of UlcraineNp753 dated October 02, 2013)
.{ogaror J\b3 - sa6egneqexnx SynxqionyBauHt rounrexcnoicr,rcreMr,r ynpaeniuus sxicrro (6ea nepenipr<r,r npoer<ty)/-Annex 3: ensuring of functioning of fuil quality assuroncesystem (w ithout de s ign examination)
[ificnufi s/Effective date : 1 I .03 .2019
fiitrrcnuft aolExpiry date:l 0.03 .2024
A.B. rlena.niH
A. Chekalin
CEPTI4OIKAT BIAIIOBIAHOC TIC er tifi c ate of C onformiQ
J\b UA.TR.126 753 19 037 02
Bmp oflnmrcl M anufo c t ur e r :
Micqe nupo6nnqrna/Address;
YuonnonaxeHnftrrpeAcraBHun n YxpainiI Authorize d r epr e s entative :
IlpoayrqislProduct:
BiauoniaaenuuoraulConforms withrequirements of:
Ilpoqeaypa Texni.rnoropeHraMeHTylTechnicalregulation procedure
.{o4arrcona inQopuraqin:
AupeDi
{ranHicrr nepeniprrur, 3BepuyBrlncb ao opraHy 3 oqinxr,r sianosiaHocri/The validity of the can be checked by contacting Certfrcation Body
Cropima |zl210135
,IICryENISO/IEC
-01102
.fi?ffia;';llEHTP
CSp!ltibiI{AIIII"i na*rrS'qlutitrllil xdA
i- asrszg6zl
npoBvnoK Xotxeguqa l-Hara, 2A, rricro KnTe, 02094, Yxpalxa . email: [email protected]. www.dmcs.in.ua. ran: (044) 559240
Ilepe.nirc MeArrrrHux supo6inlList of medical devices
Ng/# Haft nrenynaHns MeA[qHoro nupo6yyrcpailncrno rc llon,oro / Ulcr aini anproduct name
IlafinrenynaHnff MeA[rrnoro nnpo6yanrnifi crrco n llosoto/ Englis h productname
K.naclClass
I 2-xouuoHeHrni uupnqu in'exqiftnioAHopa3oBoro BLrKopr{craHnc, 6es/ zIOJIKOIO/TOJIKAMI'I
2-part disposable syringes without /withneedle/ needles
IIa
2. 3-rounoHenrni urnpnqu oAHoprroBoloBr,rKopucraH Hs 6es/z rolrcorc/rolxau u
3-part disposable syringes without /withneedle/ needles
IIa
aJ. fomn 4nx iH'enuifi MEDOJECT MEDOJECT Hypodermic needles IIa4. Cneuia.uura rorrKa MEDOJECT MEDOJECT Special needle IIa5. OSramnaoloriqHi roJrKlt INOX INOX Ophthalmic Needle IIa6. fonxu AJrfl BaK)ryrunoro :a6opy rcponi
CHIRAVACCHIRAVAC Blood Collection Needles IIa
7. Ilhpuqu CHIRANA iHcyriuori/ry6epryniuosi g/6eg iHrerponaHorcroJrKoro a6o orpeuo ynaKoBaHoroIOJIKOIO
CHIRANA Insulin /Tuberculin syringeswith/without integrated needle or sidepacked needle
IIa
8. lllnpuu-pyqna incvniuosa MEDOJECT MEDOJECT Insulin Pen Needle IIa9. IHrpanenosui rcarnoli CHIRAFLEX ra
CHIRAFLEX SAFETYCHIRAFLEX LV. Cannula andCHIRAFLEX SAFETY I.V. Cannula
IIa
10. MauApesa (o6rrcparop) CHIRAFLEX CHIRAFLEX Mandrin IIa1l InT paneuosna KaHroJrr run <<Merelvx>>
CHIRAFLEXCHIRAFLEX Scalp Vein Set IIa
12. Cncreua AJrfl nepenuBaHH{ inQyeifiHrxposqunis CHIRAPLUS
CHIRAPLUS Infusion set IIa
13. Cucreua AJrr rrepeirlreannr rponiCHIRAHEM
CHIRAI{EM Transfusion set IIa
14. Kanrors acnipaqifiHa CHIRAPLUS /3arrryuma CHIRAPLUS / IH'exqifinaftropr CHIRAPLUS
CHIRAPLUS Infusion spike /CHIRAPLUS Stopper / CHIRAPLUSIniection port
IIa
15. floaonmf.ffi hfr v sifaHuilt C HI RA LIN E CHIRALINE Extension line IIa16. 3 -ffijair ganifl ui&>xpan C HIRA WA Y CHIRAWAY Three Wav Stoo Cock IIa
{*a/,lac,trrg;1}4"p"*$g[_--:*?,lT,'trDirectffil"l'ty*urt
ou,u""ou-rruffi
A.B. rlerca.rrin
A. Chekalin
.2019
IdenmuQixaqiiluuil HoMep npusHaqeHoeo opeaHy UA.TR. 1 26
AoAarox llAnnex I.{o Ceprurfircary nianoshnocri J\b UA.TR.12675319 037 021
to Certificate of ConformityNb UA.TR.L26 753 19 037 02
AoAaror I dftcrrufi rpn Ha{BHocri Ceprr.r0irary si.{uoniAHocri Ns UA.TR. I 26 7 53 19 037 021Annex 1 is validwith Certificate of Codormity lW UA.TR.126 753 19 037 02
Cropiura 2 s 12
npoeynox Xorxeauqa l-Hara, 2A, uicto Kr,lie, 02094, yKpaiHa email: [email protected]; www.dmcs.in.ua; ren: ( 044) SSq24OO
