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

    gammaCore Sapphire

    Code: B-00815203020843
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00815203020843
    Issuing Agency
    EUDAMED
    Device Model
    gammaCore Sapphire SLC Device Kit for Evaluation (kit with refill card)
    Types
    Active
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 2a
    Manufacturer
    ElectroCore, Inc.
    Last Updated
    October 23, 2024

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 571753 May 24, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    ECOR On the market