BEUDAMED
    MDR MDR QMS Suspended

    24 0263 QR/NB

    Manufacturer: KARDI AI Technologies s.r.o.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    1146
    Valid for 1146 days
    Expiry: July 28, 2029

    Basic Information

    Number
    24 0263 QR/NB
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 29, 2024
    Expiry Date
    July 28, 2029
    Decision Date
    September 27, 2024
    Manufacturer
    KARDI AI Technologies s.r.o.

    Certificate Lifecycle

    July 29, 2024 July 28, 2029

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    ECG telemetric monitoring system

    Preceding Certificates

    24 0263 QR/NB Issued
    Issued: July 29, 2024 Expires: July 28, 2029

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.