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

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    BIACLASSICTABS

    Device
    EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·On the market

    BIAPHASERTABS

    Device
    EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·On the market

    BIACORPUS RX 4004M

    Device
    EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·On the market

    Organical CAD/CAM GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    BIACLASSICTABS

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·1 device

    BIAPHASERTABS

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·1 device

    BIACORPUS RX 4004M

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·1 device

    CAL

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

    CAL

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

    GVB-geliMED GmbH

    Importer
    🇩🇪 Germany·5 Manufacturers

    Albert Hohlkörper GmbH & Co. KG

    Importer
    🇩🇪 Germany·3 Manufacturers

    TROGE Medical GmbH

    Importer
    🇩🇪 Germany·11 Manufacturers

    Pediatric care bed; Product Designation: KayserBett IDA;

    FDA Enforcement
    Class I ·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    FDA Enforcement
    Class II ·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016

    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·May 16, 2018

    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 24, 2019

    Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·February 6, 2019

    Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 24, 2019

    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 5, 2019

    Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·September 4, 2019