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Sources: EU EUDAMED, US FDA
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EPT 0477.MDD.20/3838
Certificate
MDD Annex II (excluding section 4)·Drugs Minerals and Generics Italia S.r.l.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
EPG-0342-21
Certificate
MDD Annex II Section 4·Savio Industrial S.r.l.·ISTITUTO SUPERIORE DI SANITA'·2 Basic UDI-DIs
QCT-0170-21-03-21
Certificate
MDD Annex II Section 4·Savio Industrial S.r.l.·ISTITUTO SUPERIORE DI SANITA'·2 Basic UDI-DIs
ME 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·2 Basic UDI-DIs
QCT-0090-18-03-18
Certificate
MDD Annex II (excluding section 4)·Drugs Minerals and Generics Italia S.r.l.·ISTITUTO SUPERIORE DI SANITA'·2 Basic UDI-DIs
EPT 0477.MDD.21/4232
Certificate
MDD Annex II (excluding section 4)·Drugs Minerals and Generics Italia S.r.l.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
MED 20024
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
Lettera approvazione ISS del 04/01/2024 Prot. 216/ON-ISS.12.00 MCE 4/24
Certificate
MDD Annex II (excluding section 4)·Drugs Minerals and Generics Italia S.r.l.·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
QCT-0090-18- 06-18
Certificate
MDD Annex II (excluding section 4)·Drugs Minerals and Generics Italia S.r.l.·ISTITUTO SUPERIORE DI SANITA'·22 Basic UDI-DIs
QCT-0090-18-07-18
Certificate
MDD Annex II (excluding section 4)·Drugs Minerals and Generics Italia S.r.l.·ISTITUTO SUPERIORE DI SANITA'·2 Basic UDI-DIs
20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·3 Basic UDI-DIs
EPG-0093-18
Certificate
MDD Annex II Section 4·I.R.A. Istituto Ricerche Applicate S.p.A.·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
EPG-0252-19
Certificate
MDD Annex II Section 4·Mastelli S.r.l.·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
MD 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·4 Basic UDI-DIs
009-00-10-MDR
Certificate
MDR QMS·GRUPPO FARMAIMPRESA SRL·ITALCERT SRL
CVD002824
Certificate
MDR Technical Documentation·Alfa Intes Industria Terapeutica Splendore S.r.l.·ISTITUTO SUPERIORE DI SANITA'
ITH 2473502 1
Certificate
MDR QMS·MEDI-CARE SOLUTIONS SRL·TUV Rheinland Italia SRL
005-00-01-MDR
Certificate
MDR QMS·TECNOFAR s.p.a.·ITALCERT SRL
ITH 1986726 1
Certificate
MDR QMS·Empatica S.r.L.·TUV Rheinland Italia SRL
IT335698
Certificate
MDR QA·WORK IN PROGRESS BIO-MEDICAL S.R.L.·BUREAU VERITAS ITALIA S.P.A.