EN ISO 13485:2003

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Transkript

EN ISO 13485:2003
ELEKTROTECHNI CKY zKIJšpsx I US TAV
ELEcTRoTEcI,tN-IcAL
TEsTING INsTlTUTE
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cZEctl REPUBLIc
ELEKTROTECHN_ISCHEPRÚFAN5TALT_TSCHECHISCHEREPUBLIK
I}lSl |TUT ELEc lRoTEcHN lQUE D,tSsAlS - RFPUBLIQU E TCl l tQUF
3.IIEKTPoTExHHqEcKuii ucnb[ATEIbHbIii HHCTrryT
Pod Lisern
129,l7l 02 Plaha
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8 - Troja
Tlre Electrotechnical Tcstirrg Institute Ccrtificatiorr Body No. 3004 for certification of tnanagetnetrt systems, accrcdited by the Czeclr
Accreditation hrstitute, o.p.s. in accor<larrce with ČSN EN ISO/IEC l702l, grants the
CERTIFICATE
No.: 8l00l73
ťor the Quality System in accordance with
EN ISO 13485:2003
to the Firm
EKOVIJK MEDI,
s.r.o.
Na Maninách 1590, 170 00 Praha - Holešovice, Czech Republic
because it ascertained that the Quality System of the Firm in the field:
Production, sale and service oť medical devices type PNEUVEN
in the following locations:
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w,e'
cornplies with all requirernents of tlre above tnentioned Standard docurnented by the Repor1 No
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003375-0l/01 of: l7.09.2010.
103789-0l of: 10.10.20l l,
202863-0l of: 18.06.20l2
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Tlre Certiíjed Orgarrization is subject to annual check-ups canied out by the Certification Body. Any change witlrin the organizatiotl
cotrceming ůe certification slrall be followed up and apploved by the Electloteclrnical Testirlg Institute. The validity of this Certificate
tnay be suspended or cancelled in the everrt ofnon-colnpliance witlr the Standard on the basis ofwhich the Cetificate was issued.
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The validity oť the CeItificate is lirnited titt, :O.q.ZO
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Cerlificate glanted: 31.10.20l l
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Corrigendurn: 19.6.20 12
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