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

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    GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Limbus AI Inc.

    Manufacturer
    🇨🇦 Canada·Kiwa Dare B.V.

    SmileSonica Inc.

    Manufacturer
    🇨🇦 Canada·Intertek Medical Notified Body AB

    Epocal Inc.

    Manufacturer
    🇨🇦 Canada·2 Importers·TÜV Rheinland LGA Products GmbH

    Dominion Biologicals Limited

    Manufacturer
    🇨🇦 Canada·TÜV Rheinland LGA Products GmbH

    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.

    FDA Enforcement
    Class II ·Terminated·Response Biomedical Corp.·March 18, 2020

    HX 1804155-1

    Certificate
    IVDR QMS·Dominion Biologicals Limited·TÜV Rheinland LGA Products GmbH

    21M00123CRT01

    Certificate
    MDR QMS·Limbus AI Inc.·Kiwa Dare B.V.

    28620156455

    Certificate
    MDR QMS·SmileSonica Inc.·Intertek Medical Notified Body AB

    HX 2262557-1

    Certificate
    IVDR QMS·Epocal Inc.·TÜV Rheinland LGA Products GmbH