BEUDAMED
    12 results · 16ms · Sources: EU EUDAMED, US FDA

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    SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LiNA Medical ApS

    Manufacturer
    🇩🇰 Denmark·TUV NORD Polska Sp. z o.o

    BrainCapture ApS

    Manufacturer
    🇩🇰 Denmark·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    SP Medical A/S

    Manufacturer
    🇩🇰 Denmark·TÜV Rheinland LGA Products GmbH

    1ML ONCE Luer Centric Clear Non-sterile

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·CODAN Medical ApS·1 device

    1 ML CODAN PRIMO TBC Luer Centrisk Clear Sterile

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·CODAN Medical ApS·85 devices

    Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·May 25, 2022

    Innoventa Medica ApS

    Manufacturer
    🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB

    MDR-007

    Certificate
    MDR QMS·BrainCapture ApS·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    28620145188

    Certificate
    MDR QMS·Innoventa Medica ApS·Intertek Medical Notified Body AB

    TNP/MDR/0013/5613/2023

    Certificate
    MDR QMS·LiNA Medical ApS·TUV NORD Polska Sp. z o.o

    HZ 2320977-1

    Certificate
    MDR QMS·SP Medical A/S·TÜV Rheinland LGA Products GmbH