BEUDAMED
    10,000 results · 47ms · Sources: EU EUDAMED, US FDA

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

    FDA Pre-Market Approval
    BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D;

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR,EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EVERA S DR, EVERA S VR,EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

    DGM-0549

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

    DGM-459

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·2 Basic UDI-DIs

    DGM-458

    Certificate
    IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

    DGM-549

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·31 Basic UDI-DIs

    DGM-548

    Certificate
    IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·33 Basic UDI-DIs

    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI COVID ANTIBODY TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HCV CONTROL TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device