BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Country: Sweden ×

    Her Company AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device

    Ella

    Device
    EU MDR · Eu Md Class 1 ·Her Company AB·On the market

    Ella

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Her Company AB·1 device

    Aer Beatha AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device

    Aer8 Spacer

    Device
    EU MDD · Eu Md Class 1 ·Aer Beatha AB·On the market·32 countries

    Aer8 Spacer

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Aer Beatha AB·1 device

    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

    FDA Enforcement
    Class II ·Ongoing·Hermes Medical Solutions AB·December 18, 2024

    HEA Medical AB

    Authorized representative
    🇸🇪 Sweden