BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    CROSS DONNING AID

    Device
    EU MDR · Eu Md Class 1 ·Camp Scandinavia AB·On the market

    First Aid Eye Wash

    Device
    EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·On the market·4 countries

    First Aid Eye Wash

    Device
    EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·On the market·4 countries

    First Aid Eye Wash

    Device
    EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·On the market·2 countries

    GIA Premix First Aid Eye Wash

    Device
    EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·Not intended for eu market

    ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Legrand AB·On the market

    ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Legrand AB·On the market

    ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Legrand AB·On the market

    ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Legrand AB·On the market

    CROSS DONNING AID

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Camp Scandinavia AB·1 device

    Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    FDA Enforcement
    Class II ·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021

    Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    FDA Enforcement
    Class II ·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021

    Safly AB

    Importer
    🇸🇪 Sweden·3 Manufacturers

    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·January 10, 2018

    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    FDA Enforcement
    Class II ·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021

    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·July 10, 2019

    Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.

    FDA Enforcement
    Class II ·Terminated·Etac Supply Center Ab·July 25, 2012

    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·February 3, 2016