BEUDAMED
    MDR MDR QMS Issued

    28620136087

    Manufacturer: Koios Medical Inc.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    01
    426
    Valid for 426 days
    Expiry: August 9, 2027

    Basic Information

    Number
    28620136087
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 5, 2023
    Expiry Date
    August 9, 2027
    Revision
    01
    Manufacturer
    Koios Medical Inc.

    Certificate Lifecycle

    June 5, 2023 August 9, 2027

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Image analysis software

    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.