Taducere din limbaenolezrin limba romena

slqla nsirumentalion Laboratory

iN ATENTTA cELoF tNTERESAT|

siimaledomn.

Nol, lrstrunrernaton Laboratory s.p.A., p n pr€zgnta dec alEm ca

SANPRODI4ED SFL, Bucuresti, Romania€sle uniculnostru disl ribuilo r pe inlreg
leriloriul Rofraniei al Liniei Gem pentru setuicii Medicale de urgen!4.

DOCUIMENT VALBIL PANA LA ALTE NOTIFICAFI

P€ntru lnstrumentalion Laboratory S.p.A.

SemnStu15 indesc fabiE
Apllcata glamplaweden Group/lnstrumenlation Laboralory

lnstrumenlal on Laboralorv S.p A.

lnlemational Aea Manaqer

nstrumenralion Laboralory spa

Sede Legale, Adminislraliva e operaliva
var€ Mo.za,338 20128 Milano,ltala
Jel.+39 02 25221 Fd +39 02 2575250
 Trad!.ere din limbaenobzeln limba roman,

Sigla lnslrumentallon Laboralory

iN ATENT a cELoR tNTERESAT|

Sllmatedomn,

No, nsttumentalion Laboralory S.p.A. , avand adresa ir Viale Monza

338-20128. Milano llalia, prn prezenia aulorizirn MEDICARoM GRoUP sFL,
slr. lnlrarea Glucozei 37 39, Bucuresli Romania,]n calilate de unjc dlslributor
pe tenlorul Ro.naniei, s5 promoveze, sa vandi gisa presleze seNce, asislenl-
tehnica giiniGlnere pentru Lnia Gem.

semnel!re indesciirabi e
ApLjcala Slamplla Weden Group/lrstrumental on Laboralory

rnsrrumenrar on Labo@lory s.p.A.

lnlernational Area Manager

nstrumenlalion Laboratory SPA

Sede Legale, Adminlslraliva e operaliva
Vale lr,,lonza,338 - 20123 Milano, ltala
d
Iet.+39 02 25221 F +39 02 2575250
INSTRUMENTATION LABORATORY SPA

uNt EN lso s001 200e

lln ,
'
,'!.
D!!!ir!Li!l {:!!,r !r'! ianx
iba
fradu.s..inLab d im5i !n!l.7ri
(
c sr)e r \ nhn lrQNl I

rsjlTlro ]JL.LR rL'rcllro\r oF -l \ rlt allr,\

rLRrr(.\rNl0l54ffi

lNsl nt ltEN f'\TION t.\BOR\l()Rl sP'\

t-10D8 N,l _A\O{N1l) VIAL.L VONIA ll8
r\ rnl Lnnan&]. Ptr[r J! ruu
lirls \lll A\o lllL) \ l.\L F \n\7\ ljr
I
Ibi D0 {SCOI-IPLCF\O \l') lo\\r\Dl SIRl\lF( \RO\l'\ lri
L

I rr rLr( {\L\\(iORRL\\r\L\llr \
l r '.'. r. " rrrJ l "rlr'i " l
rLnr r'rdnl
r rNr ( r.l EN rso 9lirl 1008

lrL rtr trr rL.lorr.lt r.ir\trJir ll'DL^rq1 It

(i'r'.r.rrll^rca \Iil.mel\n lf ar icrclr\ I s r rcc
drrnonic ii \no
Pr.rccur.. Frodrrt. n \riTrre d. reNcn\ isr s'rlcnre 'l nrce c ri ricc

crRrloL\! 11\' j LLPRtSiDL\rE

\'aGajiardLrr liL:i \1lL\\O (\ll) ll \lr'\
#ffiRTFF;EATE
iUV Rheiniand cf North America. inc. -tI\.

'' 3ts tr:1g "ltatr(lfr :.a*o, a!f *.. 1 : -

ii:i'.laiwelll\vetue 180 lartvreli foec
re!rngror. iEA 92421- :1i25 tsedfo.cl. i!/iA 3'173!-2+43
USA JSA

j.s,J :ercioFr..t l1!..Jtaclure Dsrrr,:.. ;ir ::,v, 1-.r:

s R€age.ts An;r),;ersrSoha:r. Jsed ,r tr.;
i.reer i: :,a,c..srs 3r"a [4a.agenrenl.i H..]o.:::rs :i5.in. ysls Bloec
Ca3 an .r m:it tr- alectro ytes G uci.e l.3ciare 31i aioo.j;ra )ris
. -i D-. s

ISO S001: to00

i4 300 2884

.
i',. ttr'.. a,2'.t:'-'
!L{tuN,.dn nl,r er!L(/!

( [R l l ( \l'
I lrV itlr! hnd Anr.rrn d. N.tul lnt
l l a r nn.it. lloid. N.(t\\r. C l 06rilr'

r. iil(r pr frrl . ilri ' .r

lnstrumenfatio n torv Co.

130 I

Le\!'!1,$. 1V.\ 0l 1lI .lllj

,\ inpl..rrnl,t si ncntinr un si\lcn de.,litnle pcnlru

Lnd elc.ruL trr n(Lr1 ua,. i_r docrnre rrl rn raF.rlrl nr l0'lt)l
^ S I dcN!r{rL c. s. deitlnr.\r c.fr1.l. rr .n ln,Nlrr0
'
ISO 9001:2000

N1.r Dnrllc .t.l.l'r .r Drtrrr hrl.rtrtri rar..sln .ciilr.rr \i l. rflrcrrcx c.ri .Li
t\i r' .' ,- lr'. , 'l ',1 .."/..r
rtrc!rsrrrtu nl r.nrli.arulu

(.11!UcatLLl crl. \rlxhil dc Ii (. rl( fu| .s1. \al.bLl Pin^ Lir

I r|rrili.lollt "1Nlnli.l(r
l
 :-::..=. lrp+il'.
ttu.ls
TNSTRUMENTAT|oN LABoRA l.CrtaaspA

uNr EN lso 13485 2004

Documenr,n I'mba.nsl.a si naL'ur
l cdLarcpana r I dn hmbioslra)
.l\Q ntr nanhtu rl rQl\rEr

(rR FrcAro,310

I]{STRTIMENTATIO\ I-ABORATORY SPr\

120128 VILANOI\1ll \lAI F luo\Zr\ 3:18

avod u'Droarlcru'cEd.luru
r.r0L23 \rrLANO (NIr)-\1A1tr r\rO\ZA rr3
r 6100 ascolrPicLNo (Ar)-zo\A rNDfslRrAr F cANiPor liNGo. \'IA r17'
r l0rJ0cAvli\.\coBRr{\2.,\(\r) vla RoMr\ l0r

A nnplemcnrar si incnrinc n sisteflde manalemental cahrah carc csrc n

.ontonnniid cn urmamrul $.nddd
t,NI CFI F\ tSO 1t,185 2004

Pentu u.maroarclc acn\ nari COD EA29 a. 19

. or'cr. h/dr r FnPo'tc4

lJrolcclare productie t \anTare dereacti!r si vsleme cl'nicecnimice.

CFRTIO(]^LNY'1 ILPRESIDENTE
vnGc'!d,id J l0l:i VILANo (Ml) ITALIA

(rsat$!, h!r. i,r5n

'r[d-u!
SrgldSNClRT
 E CMDCA!

,nslrrm€ttallon Lail,rratoty c..

113 Hartw€ll Av?nue
iE'(ingt".. MA X2421'3125
!1S,1

Liis esiablishea :dn

OualitY lllanagenlen: Svstem
accjrrring tc
lsf] i3435:2t43
3as91t5! 0al
a..ri':t i -oistralli. 7,i 5oo 359/

Ei."i.l G3:

./,F
!)t
ir ,

..i-
l!' I
lrdtrcc, N dr r, mt,r sille4

CERTIFICAT Sisld rL \ Rhenrland

T(l\ Rhe rland.\n*icr de \.id lnc. recunos. r CiviDC,\s
cen'1i., 'cs:slnL

Insh umcntation Laboratorv Co.

113 llarNcll Arc.
Lcxington. \1.\ 02.121 t S.\

un sisr.m de nanraem$tal calnrtii

i..onrornritire cu

lS() l.ll35:20i13

nL Cer'lcd inrelisrrare

Penlru design ulsi d€zroll!.c,. trodr.riatdnrriburia si serricFnt

dispozitirrl.r d. dirgnosric in kicurilor, rc.criyilo., progranutui pe.rrn
'irr.,
inrli.rrefolositpeniru scr€ening,diagnosri.utsinrnagcn€ntulh€no3rr,.i,
litrinolizei.gazelDr in snngc, ccoxin.triei. th-utui. etNtrotiritoi stuc.zci,
lrttsiilor,inalitilo.dcsangc,inclusnadkaoritnelord€diaqno{i.inv roln
parul bo!r2vtrlui.

s,unsr'{ {.rcd(.d.3.\rs

Furniorn.sf6.art BI udor..
(l*ry*
s.,t",'igii)
oZ
.';:.t^{
?.;:_q..tl
Ta )ehon it har coht. uf {pril 1006

Me, undesriften Zanora. as LegalRelresenLarive oflnstrunenbrion

Jose
Labonbr/ S.p a. , ratd in Viale NloMa. il8 - 20128 Mitano - Tet: 0:2j22t.
!d:22575250 . heEb) conlim that Instrun€ntarion Labo.atory Spa is Lhe
sole ddlfacturer worldside lor rle canidees ritn icase s (cEM pak) used bv
C .V er ,000 d, ly p
orr"rern
p.oduct. cEM Pr.mjeri000 blood gas dali,ze.. is a dosed sysrem which
.tuot p€rforn uiir drr orher mdufactu.e. s rcagenls, bur ou patenled
cadndges (cEM Pak). ln$runenration Laboratory herebl ceni0 thai atl
cartrides (GEM Pak) that cm be used br GELf Prenier jooo ae Frodlc€d onlv
inour fadories ar Lexinqi.n, UniLed Stares.

M uo rd(0)j2!F4ior)rjxrjo
drbuurd,r ,D!r Pad! o Dueo cqr)
A$drPrso rd (dr6)'31 Fa016){r36j rd{56Lrrr rlslD
Trxdr.e.adrn I' h3 $!1.74 ron!mrl)

S q r li- rums ron LrboRu^

C,tr. rori cei intcre'rii Ii\l\ x7l/ 3 st'rilic 2006

Subrmnrh'1. loie Za'noq L,:bo.alo^ sra. n

ndjuL i vid! iuoiua :13. t0Lt3 v lao rt 0t?5??t. F lt57sli0.
_ p.i 0..zctrla.of fi m
nDi!l.ahErtrm! aror Labomrot sp. ese drtr prcdrcator din LuiP sicrnuselor cr Eaclv
(ctrM Prk) url'id.d. r,aL'-n'lGE\ Prcmcr1000
Prcdtrn,l rorm. airlLTdrrl dr sze soga GE\1 P..nn( i{roo. rep€zsra Ln skEn
'n prodrc or fl dor cL .an6e e 6ft!.rtc JN or
erdui\ $rc in F e li'nd or! ru Pad'\tr altu,
lc[\l Pak) lnnn]menh0on Laboft .rn6.l.1cE\tPal)c.o
suit dtrl,zaE de drlLzord CEM rtrmLrr 1000 sunr prodtrs nun.t d lirbnca nodtr d'o
L.xinsbo srati. Lniie ale A'n.!tr

lniiumcnhnon L.bo,do\- 5 ll i

sbnpLLr liiam$ Labo€ror!

'arotr

LJ\x]jl19!rlslli$bJrri,!
I .xdue,e d d hnti3 cDqlq l&cuEnr n,u Li,Lmr\l

\'!lil rr, .i!tro Lrbolnu--

D[Cl,lR\'l t u Dl] ( o\!'()R]ltTA rE cr:

!:1001)
Sitem(;LM O I'remier

lrsn ume.iailon Lxborx(o.y Co

Lc\irqan \lA 02421 SLA

Petre/e rn r ruro zit I E hrs1nDenla(ion laliorrtory Spa

20118- Nlilano lhl'a

Ltrbo,rLo'! Lle!a'a c. rrodusul( c.) e.umeDle ini,loj
n{L .oituin. cu dftc rle s nmdsn,A c LtrLui, I:uropei. sDecrll.irc r a.dn:

lvD43/79lCn(27110r1993) Anr$liilll

! ISO t|011,,00 srLenr.. nDrgeiic rl .:l hr L

. l\O lraii rq9ar,Dapo,!\rd,.c,.trle Strren,.de.al'rar.

. ll CFR Pidci 309 10. slz 5. 31! lr0 3:0 16! (r). 1J20 11) 320 ?0
. lso lr9?l 1000. D6poznr'c n.d'dle mrnalemerrllu rscunLorh
dtoour eriedrrle ^plGrer
. llN6l0l0 L le9!-l\) 02 \of,ne ds !c.u' de pcr! .chlp3nretuui eledn.
'
oditurrstrare conto sirzde Li,{oiaror pidlx I ttrir.s.neELe
Pan$ I l.nnre lpecLlLd .phqb'le edipa {!ulu,
'nedLcal
PsN dmgionillra n !tr'o
r l\61010Iosl (tnDre:pecrk apl, b Lc crhiprmc rh,id.ldb.,rl.r oDar
! ie xurotr,ar 1016 I petratr arrLue i . L!\.optrr
l9sa aldr A Eni., r.drb s t.ni,:,hh. Imunrarc Mexa Bj
' FN6lrl6l
e.hLprmenl eLet!. dc DastrE. co'rioln u peniu hbonior
. E\ 'r30 1996'A lo93 s,mb.lun !nil.. url'zxrc pcnn ench.hrea
d6rozilir.Lo, !n.d ca e
. ISO ljlli 1000 DLpo.r!e Nledr.al. S'fiboLLtr'.arc aebtrie triLdre la

.u -.r'. i r' u
d'"qroni. Ln !Ldo petrn ut'.lctr.nnt
 t LN 391 lO0L Inshcnuni de d liac pdnh i'xrunr.nic de dFg.osr m \rbo
penitu zprolesonrt

Lex,iglo(. seprenbne :006

Dtrcct rdc lnsun'u CalLht, !emnatura nidesc,fa6Llr

fj:l CI-AIRI]E IHFOBAT,I)

(ilv P,cnrcr1000 Pak p€itro g.z€ Ln

f'
0002.13 rj0q?

L9-"4j!!l]aiqo,:ri!
!t!
6E\1 Pfu e :1000
P'efte, t rr0 Pa[ Deituor,€
Prr pen ! ea4 r

lnqr 11.rt ediu , ClurorL:dr

catus pentru ri de bne i 4epEmri i)

!4u:!e'ru u ll!!!c!k ( rspammr)
l0:o?1107j34

oo0r.lrrooii
 c€M Pr.nie,3000 Pak iQr\,r petrnu L

ae in sqe /Hcr,lledrolii,
E.;;F., .a!'.rj!14.;p;;-,-

tail i,"; r,' aii ;,;

Li,r r'nnlr",rooo
Hrr Fler tulr 6 lszJ

t 11!i pJ!!.el: !!1919

r-
I '!:E!!!fq
Cafr.enn'l50Le.e
Le,j

Dtulcrcl fi tlA $Jltru

! r IM1^r,
r rrrrra,rvornur,* 5\)9
'""
I, d!rcj!! !j! LiEla e,,stea tdjqllenr nuhirils!)
sigl. lJBltonc .rionLnboBrory

Df,CLAR"C.TIf DE CONfOR]\TITATE CE

lnslrumentalion l,aboratory Co

I-e\inslor MA 02421 SUA

l*a--* hrst ume.ration Iaborarort Spa

20128' Milano Iralia

Pnn pre.nra ln{Dmenrarioi produsul (c1el cDumcrare fraijos

su coniofre d dnecrivele Europe e specificxk ir @nn

DirecIiY,lJf,:
iVD-93/?9/CE ( 2?/10/r993)-An.x, I si III
Siandard {el:
E\ t,t4l

Dnec n peniru Asiq!irs Calnatii

Instufremaion L-ahorarory2002/2txl3
slslr Ii{mnenianon Labomrdtu

CVP (p.odus petr!a valldarei calibmrii)

002,1001413- l.l2l Contll 0

u.l.(M'*
0043,{00
100!ql6l! 'or' .p-''ml-.I \0.04
0e3.133s0 cdnr]l qped]m]'e'e] lll N0Il097 l
oorioo.c, \P,p"d, o.1r .dioi,ed.3l0d-,,r.,cr ' .r0l
C\T'o lr pna...da6 dlbrfr""\el : 301
.'\o p'od. c'ra."drer.a b'dn'l-e I i3'
Hen'atoc' r Chcck t oN N0632131 -
000o3... 0 rFTi.,.' her tn.l \0- :
00,63i !. . 9 r" ". 'I dtb' ro \0 2-?
\,luLri l aO Orirneicr t.evel ?
MlLtl4 (ro-Oximctci l-evel l
MLLti .l CiO (ximebr:ont l
Ahc Aditi.ialBlo.d aon r Mtrlri
Cen Crit r'hcck M'nribvcl
!4' 2_00
111e """r,qep, ,'l|:.| ht"o
L r'o3 | r'.' d 'l_r - c:'T
ro.' .r:4rrL$ L LllI rr
0105 dlo qh-An,li-h Bmd(.n".1 \.J.,.,.
0005llltoll IAh.AnificialBlo.dc.nr.rN.tr,r
Abc AdificlslBl.od a.n.l lke or r
l({nalSraid.rd I 5 nmol/L Cs
oruriede sp.b4

Iooo,s]'adt
la.r**:r*, Abc AdificialBlood aontroL Hi
7 l3a!ll Relerence Bufler
000q3r Lr0l CLan nt SoluLi,r
000rr|rllrr ler! n! Soufor

vddrtrLL:icu *dR la le.urNt2003

rn{tumefrri.n r abo,aroN 2001/2003

{a r?

l i;d; wrl -

!Mro! - t-l

!l0i

\^-)b.. Rd-*is-;d-'d
P'l!l!| 1!r!r:rr!rq

*n&un no c\pn h l9 fl's$101)li