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

    gammaCore Sapphire D

    Code: B-00815203021086
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00815203021086
    Issuing Agency
    EUDAMED
    Device Model
    gammaCore Sapphire D Device Kit 36-month Preprogrammed
    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    Expired / Withdrawn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