BEUDAMED
    101 results · 67ms · Sources: EU EUDAMED, US FDA

    OptoMonitor 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoWire III

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Opto Wire and OptoMonitor System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SavvyWire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PacePro Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptoMonitor

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Opsens Inc.·1 device

    OptoMonitor 3

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Opsens Inc.·1 device

    OptoWire Deux Pressure Guidewire with Gauge Connector

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Opsens Inc.·1 device

    OptoWire III Pressure Guidewire

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Opsens Inc.·1 device

    CE 597147

    Certificate
    MDD Annex II (excluding section 4)·Opsens Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    CE 597148

    Certificate
    MDD Annex II (excluding section 4)·Opsens Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    Opsens B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    ProCardia Medical sp. z o.o.

    Importer
    🇵🇱 Poland·1 Manufacturer

    TOP Medical B.V.

    Importer
    🇳🇱 Netherlands·6 Manufacturers

    Bisping Medizintechnik GmbH

    Importer
    🇩🇪 Germany·13 Manufacturers

    Adhesive Backed Thermal Skin Patches

    FDA classification
    FDA Class 1 ·Adhesive Backed Thermal Skin Patches

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices