BEUDAMED
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    Berlin Heart GmbH

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device

    EXTRA-CORPOREAL CIRCULATION SYSTEMS

    Device
    EU MDR · Eu Md Class 2b ·Berlin Heart GmbH·On the market·27 countries

    BERLIN HEART GMBH

    FDA registration
    BERLIN HEART GMBH·2 products·🇩🇪 Germany

    Stationary driving unit Ikus Rev. 2.1

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Berlin Heart GmbH·1 device

    EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

    FDA Enforcement
    Class II ·Ongoing·BERLIN HEART GMBH·June 17, 2026

    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.

    FDA Enforcement
    Class I ·Terminated·BERLIN HEART GMBH·May 31, 2023

    Berlin Heart GmbH

    System producer
    🇩🇪 Germany