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Sources: EU EUDAMED, US FDA
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CE 689660
Certificate
MDD Annex II (excluding section 4)·CSA Medical·BSI Group The Netherlands B.V.·2 Basic UDI-DIs
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
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