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

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    Filters Country: Sweden ×

    NuvoAir AB

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

    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

    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

    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

    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.

    FDA Enforcement
    Class II ·Ongoing·HemoCue AB·July 9, 2025

    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