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Sources: EU EUDAMED, US FDA
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EPT 0477.MDD.19/3104.1
Certificate
MDD Annex II (excluding section 4)·Labomar S.p.A.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
G1 098021 0005
Certificate
MDD Annex II (excluding section 4)·Pie Medical Imaging B.V.·TÜV SÜD Product Service GmbH·23 Basic UDI-DIs
V1 105961 0002
Certificate
IVDD Annex IV (excluding sections 4, 6)·Ace Medical Technology Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
MD 31136
Certificate
MDD Annex II (excluding section 4)·Xmed-MF·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
MED 31136
Certificate
MDD Annex II (excluding section 4)·Xmed-MF·KIWA CERMET ITALIA S.P.A.·143 Basic UDI-DIs
MED 31137
Certificate
MDD Annex II (excluding section 4)·Xmed-MF·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
41377505-00
Certificate
MDD Annex II (excluding section 4)·MicroSurgical Technology Inc.·INTERTEK SEMKO AB·19 Basic UDI-DIs
M.2024.MDR.1046
Certificate
MDR QA·Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.·UDEM Adriatic d.o.o.
TNP/MDD/0376/5182/2021
Certificate
MDD Annex II (excluding section 4)·CHIROMEGA·TUV NORD Polska Sp. z o.o·6 Basic UDI-DIs
26007
Certificate
MDD Annex II (excluding section 4)·Messer Tatragas, spol. s r.o.·CERTIQUALITY S.r.l.·36 Basic UDI-DIs
P22-01624-250637
Certificate
MDD Annex II (excluding section 4)·Agepha Pharma·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI
2024-MDR/QS-022
Certificate
MDR QMS·Herb-Pharma Corporation s.r.o.·3EC International a.s.
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