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ITH 1450762 1

Certificate
MDR QMS·Sky Medical a.s.·TUV Rheinland Italia SRL

2024-MDR/QS-010

Certificate
MDR QMS·TatraMed Software s.r.o.·3EC International a.s.

2022-MDR/QS-027

Certificate
MDR QMS·CHIRANA T.Injecta, a.s.·3EC International a.s.

2022-MDR/QS-026

Certificate
MDR QMS·CHIRANA T.Injecta, a.s.·3EC International a.s.

2022-MDR/QS-025

Certificate
MDR QMS·CHIRANA T.Injecta, a.s.·3EC International a.s.

2022-MDR/QS-024

Certificate
MDR QMS·CHIRANA T.Injecta, a.s.·3EC International a.s.

2022-MDR/QS-022

Certificate
MDR QMS·MEDIST, s.r.o.·3EC International a.s.

2019-MDD/QS-032

Certificate
MDD Annex VI·TatraMed Software s.r.o.·3EC International a.s.·1 Basic UDI-DI

01801

Certificate
MDD Annex II (excluding section 4)·Lenstec (Barbados) Inc.·BSI Group The Netherlands B.V.·761 Basic UDI-DIs

144878-19-04-04

Certificate
MDD Annex II (excluding section 4)·UTAS Technologies·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.·4 Basic UDI-DIs

144941-19-06-18

Certificate
MDD Annex II (excluding section 4)·UTAS Technologies·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.·3 Basic UDI-DIs

2020-MDD/QS-005

Certificate
MDD Annex II (excluding section 4)·TATRAMED spol. s r.o.·3EC International a.s.·1 Basic UDI-DI

26007

Certificate
MDD Annex II Section 4·Messer Tatragas, spol. s r.o.·CERTIQUALITY S.r.l.·3 Basic UDI-DIs

2195-MED-2036501

Certificate
MDD Annex II (excluding section 4)·Cerdak (Pty) Ltd·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

2020-MDD/QS-006

Certificate
MDD Annex II (excluding section 4)·TatraMed Software s.r.o.·3EC International a.s.·1 Basic UDI-DI

01081

Certificate
MDD Annex II (excluding section 4)·Lenstec (Barbados) Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

SBL-3™

Certificate
MDD Annex II (excluding section 4)·Lenstec (Barbados) Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Softec HD3™

Certificate
MDD Annex II (excluding section 4)·Lenstec (Barbados) Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

ThoraxBelt

Basic UDI-DI
EU MDR · Eu Md Class 1 ·POSTHORAX s.r.o.·1 device

Argon med. Messer 15,3m3 F50 P300

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Messer Tatragas, spol. s r.o.·1 device