BEUDAMED
    Basic UDI-DI Eu Mdd Eu Md Class 3 🇺🇸 United States

    Stellarex .035 OTW Drug-coated Angioplas

    Code: B-00813132027070
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00813132027070
    Issuing Agency
    EUDAMED
    Types
    Administering medicine Medicinal product
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 3
    Manufacturer
    Spectranetics Corporation
    Last Updated
    January 10, 2025

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    MDD Annex II Section 4 CE 634229 Dec 30, 2022

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Stellarex 0.035" OTW Drug-coated Angioplasty Balloon On the market