BEUDAMED
    152 results · 20ms · Sources: EU EUDAMED, US FDA

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    Intelli-C, Left side suspended Tabletop, REF: 03400010

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 3, 2020

    ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 3, 2020

    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

    Hettich Labinstrument

    Importer
    🇩🇰 Denmark·3 Manufacturers

    BGI EUROPE A/S

    Manufacturer
    🇩🇰 Denmark·103 Basic UDI-DIs·116 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    XO CARE A/S

    Manufacturer
    🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·DNV Product Assurance AS and DNV Product Assurance AS

    NRT X-Ray A/S

    Manufacturer
    🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS and DNV Product Assurance AS

    Cortrium ApS

    Manufacturer
    🇩🇰 Denmark·4 Basic UDI-DIs·4 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    BIBAWO Medical A/S

    Manufacturer
    🇩🇰 Denmark·2 Basic UDI-DIs·4 Devices·DNV Product Assurance AS

    Cardia International A/S

    Manufacturer
    🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    Hedia ApS

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

    DDD-Diagnostic A/S

    Manufacturer
    🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS

    MedArt ApS

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·GMED SAS

    Reapplix A/S

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·Eurofins Electric & Electronics Finland Oy