BEUDAMED
    MDR MDR QMS Issued

    2023-MDR/QS-006

    Manufacturer: Aireen a.s.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    711
    Valid for 711 days
    Expiry: May 19, 2028

    Basic Information

    Number
    2023-MDR/QS-006
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 19, 2023
    Expiry Date
    May 19, 2028
    Revision
    00
    Manufacturer
    Aireen a.s.

    Certificate Lifecycle

    May 19, 2023 May 19, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Medical device software-not included in other classes

    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.