BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    NeuroTrac® IFC Rehab

    Device
    EU MDR · Eu Md Class 2a ·Verity Medical Ltd.·On the market·3 countries

    Mirai Medical Limited

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    EPORE Generator

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    EPORE Generator

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    EPORE Generator

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    CUTIS

    Device
    EU MDD · Eu Md Class 2b ·Mirai Medical Limited·On the market·7 countries

    EndoVE

    Device
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·On the market·7 countries

    Alinity i Estradiol Reagent Kit, List Number 07P5020

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Progesterone Reagent Kit, List Number 08P3620

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Free T4 Reagent Kit, List Number 07P7030

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i TSH Reagent Kit, List Number 07P4830

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·August 14, 2019

    ePORE Generator

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    EPORE Generator

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    EPORE Generator

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    EndoVE

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Mirai Medical Limited·1 device

    CUTIS

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Mirai Medical Limited·1 device

    2027/MDD

    Certificate
    MDD Annex II (excluding section 4)·Mirai Medical Limited·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·5 Basic UDI-DIs