BEUDAMED
    MDR MDR QMS Supplemented

    MDR-006

    Manufacturer: Smart Blood Analytics Swiss SA
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    2
    931
    Valid for 931 days
    Expiry: December 26, 2028

    Basic Information

    Number
    MDR-006
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    April 15, 2024
    Expiry Date
    December 26, 2028
    Revision
    2
    Manufacturer
    Smart Blood Analytics Swiss SA

    Certificate Lifecycle

    April 15, 2024 December 26, 2028

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Medical device software – not included in other classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    MDR-006 Issued
    Issued: December 27, 2023 Expires: December 26, 2028

    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.