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