BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Competent Authority: Health Products Regulatory Authority, Medical Devices Department × Notified Body: 3 Ec International A.S. × Clear all

    Elixir Medical Corporation

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices·3 Importers·3EC International a.s., 3EC International a.s., and 3EC International a.s.

    BrainU Co.,Ltd.

    Manufacturer
    🇰🇷 South Korea·1 Basic UDI-DI·1 Device·3EC International a.s.

    2020-MDD/QS-086/A

    Certificate
    MDD Annex II Section 4·Elixir Medical Corporation·3EC International a.s.·2 Basic UDI-DIs

    2020-MDD/DE-087/A

    Certificate
    MDD Annex II Section 4·Elixir Medical Corporation·3EC International a.s.·1 Basic UDI-DI

    2021-MDD/QS-008

    Certificate
    MDD Annex II (excluding section 4)·BrainU Co.,Ltd.·3EC International a.s.·1 Basic UDI-DI

    DynamX Sirolimus Eluting Coronary Bioadaptor System

    Device
    EU MDD · Eu Md Class 3 ·Elixir Medical Corporation·On the market·3 countries

    DynamX Sirolimus Eluting Coronary Bioadaptor System

    Device
    EU MDD · Eu Md Class 3 ·Elixir Medical Corporation·On the market·3 countries

    CAI Monitoring System

    Device
    EU MDD · Eu Md Class 2b ·BrainU Co.,Ltd.·On the market·1 country

    DynamX Sirolimus Eluting Coronary Bioadaptor System

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Elixir Medical Corporation·1 device

    DynamX Sirolimus Eluting Coronary Bioadaptor System

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Elixir Medical Corporation·1 device

    Depth of Anesthesia Monitoring System

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·BrainU Co.,Ltd.·1 device