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

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    HME, 22F/15M, 22/15mm

    Device
    EU MDR · Eu Md Class 2a ·GaleMed Corporation·On the market·1 country

    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    HME with luer lock port (dead space 60ml)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    HME with luer lock port (dead space 45ml)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    HME with luer lock port (dead space 19ml)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    Angled HME with luer lock port (dead space 71ml)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    No. V1 097447 0006

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

    No. V1 097447 0006

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

    No. V1 097447 0006

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    Disposable Head Strap

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    Silicone Head Strap, Child

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    Silicone Head Strap, Adult

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    FitMax Headstrap, (for mask M, L, XL)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    FitMax Headstrap, S

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

    FitMax Headstrap, XS

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device