BEUDAMED
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    EXCOR®

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·September 23, 2024

    V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    FDA Recall
    Terminated ·Product code LXH·June 27, 2016

    V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    FDA Recall
    Terminated ·Product code LXH·June 27, 2016

    TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    FDA Recall
    Terminated ·Product code LXH·June 27, 2016

    GENSPEED Biotech

    Manufacturer
    🇦🇹 Austria·1 Basic UDI-DI·1 Device·QMD Services GmbH, QMD Services GmbH, QMD Services GmbH, and QMD Services GmbH

    MacroArray Diagnostics

    Manufacturer
    🇦🇹 Austria·11 Basic UDI-DIs·13 Devices·QMD Services GmbH

    Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.

    Manufacturer
    🇹🇷 Türkiye·45 Basic UDI-DIs·45 Devices·QMD Services GmbH

    Vitamin D xPOC

    Device
    EU IVDR · Eu Ivd Class B ·GENSPEED Biotech·On the market·1 country

    Curatia Medical Limited

    Manufacturer
    🇨🇳 China

    SULOX, HEAD, M, 32/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·September 25, 2017

    Vitamin D xPOC

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·GENSPEED Biotech·1 device

    IQMS/00001/0v002

    Certificate
    IVDR QMS·Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.·QMD Services GmbH

    IQMS/00003/0 v002

    Certificate
    IVDR QMS·MacroArray Diagnostics·QMD Services GmbH

    ITDA/00002/0 v002

    Certificate
    IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH

    ITDA/00002/0 v001

    Certificate
    IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH

    IQMS/00002/0v001

    Certificate
    IVDR QMS·GENSPEED Biotech·QMD Services GmbH

    ITDA/00002/0

    Certificate
    IVDR Technical Documentation·GENSPEED Biotech·QMD Services GmbH·1 Basic UDI-DI

    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.

    FDA Recall
    Terminated ·Tec Com Gmbh Eingang B Am Krummling 1 Kabelsketal Germany·Product code DWJ·August 14, 2018

    QMD Services GmbH

    Notified body
    🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices