BEUDAMED
    Basic UDI-DI Eu Mdd Eu Md Class 2a 🇺🇸 United States

    ComfortGel Blue / ProFile Lite Family

    Code: B-00606959044197
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    2

    Basic Information

    UDI-DI Code
    B-00606959044197
    Issuing Agency
    EUDAMED
    Types
    None provided
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 2a
    Manufacturer
    Respironics Inc.
    Last Updated
    February 26, 2025

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) G1 015581 0611 May 26, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Profile Lite 2 SE with Headgear, Medium, Italy On the market