BEUDAMED
    Basic UDI-DI Eu Mdr Eu Md Class 2a

    Iriscope Biopsy Procedure Pack

    Code: PP10078IRIS.KITCAT33
    View on EUDAMED
    Devices
    2
    Certificates
    0
    Notified Bodies
    0
    Auth. Representatives
    0

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    Basic Information

    UDI-DI Code
    PP10078IRIS.KITCAT33
    Issuing Agency
    IFA
    Types
    None provided
    Regulation
    Eu Mdr
    Classification
    Eu Md Class 2a
    Last Updated
    April 11, 2025

    Medical Purpose

    The procedure pack is intended to provide appropriate disposable devices necessary to take a biopsy sample in the lung tracts in combination with the video-endoscopic probe Iriscope, down to peripheral bronchi. The procedure pack must be used during an endoscopic intervention in combination with reusable devices intended to identify the biopsy site. The procedure pack must also be used in the operating channel of a bronchoscope. It includes one guide sheath, one syringe to flush, and one biopsy forceps.

    Certificate Health

    No certificates associated with this Basic UDI-DI.

    Associated Devices

    This Basic UDI-DI is associated with 2 devices.

    Name Status
    Iriscope Biopsy Procedure Pack On the market
    Iriscope Biopsy Procedure Pack On the market