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

    iCLAS™ Cryoablation Catheter

    Code: B-109-0013-001S9
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    2

    Basic Information

    UDI-DI Code
    B-109-0013-001S9
    Issuing Agency
    EUDAMED
    Device Model
    109-0013-001
    Types
    None provided
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 3
    Manufacturer
    Adagio Medical, Inc.
    Last Updated
    February 14, 2024

    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) G1 103403 0002 May 26, 2024
    MDD Annex II Section 4 G7 103403 0005 May 26, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    iCLAS™ Cryoablation Catheter On the market