BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd General 🇺🇸 United States

    Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit - 50 Count

    Code: B-00861900000398
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00861900000398
    Issuing Agency
    EUDAMED
    Device Model
    100218
    Types
    Kit Human tissues Professional testing Near patient testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd General
    Manufacturer
    CoaguSense Inc.
    Last Updated
    August 16, 2024

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    1
    Expired / Withdrawn
    0
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) MD 662930 Jun 20, 2026

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit On the market