BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    DxC 700 AU, REF: B86444, B86446

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024

    Abbott Diagnostics Medical Co., Ltd.

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    BLOOD COLLECTION, CAPILLARY TUBES

    Device
    EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·On the market

    BUFFERS

    Device
    EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·On the market

    Determine

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market

    HIV AG/AB COMBI - RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries

    Determine HIV Early Detect

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

    EDTA Capillary Tubes

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

    Determine HIV Controls

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

    Chase Buffer

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

    V7 103108 0005

    Certificate
    IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    V7 103108 0007

    Certificate
    IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI