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

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    TRANSYSTEM AMIES WITH CHARCOAL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TRANSYSTEM LIQUID AMIES MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TRANSYSTEM AMIES W/O CHARCOAL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    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

    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