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

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    NuvoAir AB

    Manufacturer
    🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018

    Tietoevry AB

    Manufacturer
    🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·Eurofins Electric & Electronics Finland Oy

    Tietoevry Sweden AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·2 Devices·Eurofins Electric & Electronics Finland Oy

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017

    PulseLavage AB

    Manufacturer
    🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·April 11, 2018

    OrthoLavage

    Device
    EU MDD · Eu Md Class 2a ·PulseLavage AB·On the market·2 countries

    GreenPulse

    Device
    EU MDD · Eu Md Class 3 ·PulseLavage AB·On the market·2 countries

    RetraLight

    Device
    EU MDD · Eu Md Class 2a ·PulseLavage AB·On the market·3 countries

    RetraLight

    Device
    EU MDD · Eu Md Class 2a ·PulseLavage AB·On the market·3 countries

    OrthoLavage® Hip/Knee Set

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·PulseLavage AB·1 device

    GreenPulse Hip/Knee Set

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·PulseLavage AB·1 device

    RetraLight LED Light Retractor (without Teeth)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·PulseLavage AB·1 device

    RetraLight LED Light Retractor

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·PulseLavage AB·1 device

    FI23/00000051

    Certificate
    MDR QMS·NuvoAir AB·SGS FIMKO OY

    CR-03-1228-849-24

    Certificate
    MDR QMS·Tietoevry AB·Eurofins Electric & Electronics Finland Oy

    CR-03-1231-829-23

    Certificate
    MDR QMS·Tietoevry Sweden AB·Eurofins Electric & Electronics Finland Oy

    C-01-1196-749-20

    Certificate
    MDD Annex V·PulseLavage AB·Eurofins Electric & Electronics Finland Oy·4 Basic UDI-DIs