10,000 results
·
48ms
·
Sources: EU EUDAMED, US FDA
FDA Pre-Market Approval
BRAVA CRT-P,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA Pre-Market Approval
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA Pre-Market Approval
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA Pre-Market Approval
BRAVA CRT-D,CONCERTO II CRT-D, CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA Pre-Market Approval
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA Pre-Market Approval
BRAVA CRT-D,BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA MRI ICD
FDA Pre-Market Approval
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRT
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·APTIMA HCV QUANT DX ASSAY
Colli-Pee® UAS® FV-5040
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·1 device
Colli-Pee® UCM® FV-5020
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
Colli-Pee® FV-5020
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·5 devices
ORAgene
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·9 devices
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
OMNIgene GUT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·1 device
OMNIgene ORAL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·2 devices
OG-AC1
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·1 device
ORAcollect (Swab based RNA Collection Device)
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·1 device
ORAcollect (Swab based DNA & Dx Collection Device)
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·3 devices
FDA Pre-Market Approval
BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA S DR ICD
1434-IVDD-254/2022
Certificate
IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs