BEUDAMED
    MDR MDR QMS Supplemented

    010-00-06-MDR

    Manufacturer: GRUPPO FARMAIMPRESA SRL
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    06
    580
    Valid for 580 days
    Expiry: January 9, 2028

    Basic Information

    Number
    010-00-06-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 19, 2024
    Expiry Date
    January 9, 2028
    Revision
    06
    Manufacturer
    GRUPPO FARMAIMPRESA SRL

    Certificate Lifecycle

    June 19, 2024 January 9, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice

    Preceding Certificates

    010-00-05-MDR Supplemented
    Issued: November 30, 2023 Expires: January 9, 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.