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

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    SO telesc. smoke evac. handle, NSTC,4.5m

    Device
    EU MDD · Eu Md Class 2b ·KLS Martin GmbH + Co. KG·On the market·32 countries

    BGS Beta-Gamma-Service GmbH & Co KG

    FDA registration
    BGS Beta-Gamma-Service GmbH & Co KG·47 products·🇩🇪 Germany

    BGS BETA-GAMMA-SERVICE GMBH & CO KG

    FDA registration
    BGS BETA-GAMMA-SERVICE GMBH & CO KG·82 products·🇩🇪 Germany

    BGS Beta Gamma Service GmbH & Co KG

    FDA registration
    BGS Beta Gamma Service GmbH & Co KG·20 products·🇩🇪 Germany

    Gründler GmbH

    Manufacturer
    🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

    Fiagon GmbH

    Manufacturer
    🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY

    PAUSCH Medical GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    Rhyk Technologies GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    SO telesc. smoke evac. handle, NSTC,4.5m

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·KLS Martin GmbH + Co. KG·1 device

    170770416

    Certificate
    MDD Annex II (excluding section 4)·KLS Martin GmbH + Co. KG·DQS Medizinprodukte GmbH·1 Basic UDI-DI

    Heinz Herenz Medizinalbedarf GmbH

    Importer
    🇩🇪 Germany·13 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

    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. 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.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 12, 2019