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

    Polysmith 12.2

    Code: B-00817111021257
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00817111021257
    Issuing Agency
    EUDAMED
    Device Model
    12.2
    Types
    Active Software
    Regulation
    Eu Mdd Legacy
    Classification
    Eu Md Class 2a
    Manufacturer
    Neurotronics, LLC
    Last Updated
    August 15, 2023

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 10000463613-PA-NA-NOR May 27, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE On the market