BEUDAMED
    MDR MDR QMS Issued

    ES23/00000553

    Manufacturer: CARDIVAIS S.A.
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    722
    Valid for 722 days
    Expiry: May 30, 2028

    Basic Information

    Number
    ES23/00000553
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 30, 2023
    Expiry Date
    May 30, 2028
    Revision
    1
    Manufacturer
    CARDIVAIS S.A.

    Certificate Lifecycle

    May 30, 2023 May 30, 2028

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    MDN1202 & MDS1005

    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.