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Sources: EU EUDAMED, US FDA
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170726773
Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs
059786 MR2 170726773
Certificate
MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs
1434-MDD-106/2021
Certificate
MDD Annex II Section 4·PRP Science Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·21 Basic UDI-DIs
1434-MDD-107/2021
Certificate
MDD Annex II Section 4·PRP Science Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·21 Basic UDI-DIs
7074GB410200529
Certificate
MDD Annex II (excluding section 4)·Shenzhen PRO HITU Medical Co., Ltd.·DNV MEDCERT GmbH·1 Basic UDI-DI
GB24/00000191
Certificate
MDR QMS·Reckitt Benckiser Healthcare (UK) Limited·SGS Belgium NV
GB24/00000192
Certificate
MDR QA·Reckitt Benckiser Healthcare (UK) Limited·SGS Belgium NV
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