BEUDAMED
    MDR MDR QMS Issued

    IT328666

    Manufacturer: SIGMA ENGINEERING S.r.l.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    947
    Valid for 947 days
    Expiry: January 11, 2029

    Basic Information

    Number
    IT328666
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    January 12, 2024
    Expiry Date
    January 11, 2029
    Revision
    1
    Manufacturer
    SIGMA ENGINEERING S.r.l.

    Certificate Lifecycle

    January 12, 2024 January 11, 2029

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    MDA 0308 - Active non-implantable devices for wound and skin care

    Quality Procedure Scope

    Device Class IIb

    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.