BEUDAMED
    25 results · 72ms · Sources: EU EUDAMED, US FDA

    Contour+ (MVision AI Segmentation)

    FDA registration
    MVISION AI Oy·1 product·🇫🇮 Finland

    MVision AI Segmentation

    FDA registration
    MVISION AI Oy·1 product·🇫🇮 Finland

    MVision AI Oy

    Manufacturer
    🇫🇮 Finland·3 Basic UDI-DIs·3 Devices

    Contour+ (MVision AI Segmentation)

    Device
    EU MDR · Eu Md Class 2a ·MVision AI Oy·On the market·15 countries

    Dose+

    Device
    EU MDR · Eu Md Class 2a ·MVision AI Oy·On the market·1 country

    MVision Segmentation Service

    Device
    EU MDD · Eu Md Class 1 ·MVision AI Oy·On the market·21 countries

    MVision AI Segmentation

    FDA 510(k)
    FDA Class 2 ·Radiology

    Contour+ (MVision AI Segmentation)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Contour+ (MVision AI Segmentation)

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·MVision AI Oy·1 device

    Dose+

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·MVision AI Oy·1 device

    MVision Segmentation Service

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·MVision AI Oy·1 device

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Relia IPG

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS

    Advanced RBC Application

    FDA 510(k)
    FDA Class 2 ·Hematology

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    Eunitor GmbH

    Authorized representative
    🇩🇪 Germany·83 Manufacturers·896 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices