BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    BI X GmbH

    Manufacturer
    🇩🇪 Germany

    NEBU-TEC med. Produkte Eike Kern GmbH

    Manufacturer
    🇩🇪 Germany

    EIT EMERGING IMPLANT TECHNOLOGIES GMBH

    FDA registration
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH·4 products·🇩🇪 Germany

    ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    e-fix E36

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Alber GmbH·7 devices

    e-fix E35

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Alber GmbH·25 devices

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025