BEUDAMED
    MDR MDR QMS Issued

    0425-MDR-030020-00

    Manufacturer: ENABLE INNOVATIONS SRL
    Basic UDI-DIs
    0
    Scopes
    5
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    627
    Valid for 627 days
    Expiry: February 26, 2028

    Basic Information

    Number
    0425-MDR-030020-00
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 27, 2023
    Expiry Date
    February 26, 2028
    Revision
    00
    Manufacturer
    ENABLE INNOVATIONS SRL

    Certificate Lifecycle

    February 27, 2023 February 26, 2028

    Scopes

    5 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Gocce oculari monodose e polidose Single-dose and multidose eye drops

    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.