BEUDAMED
    MDR MDR QMS Supplemented

    009-00-10-MDR

    Manufacturer: GRUPPO FARMAIMPRESA SRL
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    10
    580
    Valid for 580 days
    Expiry: January 9, 2028

    Basic Information

    Number
    009-00-10-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    January 7, 2025
    Expiry Date
    January 9, 2028
    Revision
    10
    Manufacturer
    GRUPPO FARMAIMPRESA SRL

    Certificate Lifecycle

    January 7, 2025 January 9, 2028

    Scopes

    2 scopes covering 1 risk classes

    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

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    009-00-09-MDR Supplemented
    Issued: October 24, 2024 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.