BEUDAMED
    MDR MDR QA Issued

    0425-MDR-030023-00

    Manufacturer: NOVYSTEM S.p.A.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    689
    Valid for 689 days
    Expiry: April 27, 2028

    Basic Information

    Number
    0425-MDR-030023-00
    Type
    MDR QA
    Legislation
    MDR
    Issue Date
    April 28, 2023
    Expiry Date
    April 27, 2028
    Revision
    00
    Manufacturer
    NOVYSTEM S.p.A.

    Certificate Lifecycle

    April 28, 2023 April 27, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Sep4Angio

    Quality Procedure Scope

    Device Class IIa

    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.