BEUDAMED
    MDR MDR QMS Supplemented

    CR-03-1230-861-24

    Manufacturer: Orion Corporation
    Basic UDI-DIs
    0
    Scopes
    13
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    01
    927
    Valid for 927 days
    Expiry: December 22, 2028

    Basic Information

    Number
    CR-03-1230-861-24
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 20, 2024
    Expiry Date
    December 22, 2028
    Revision
    01
    Manufacturer
    Orion Corporation

    Certificate Lifecycle

    December 20, 2024 December 22, 2028

    Scopes

    13 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    MDA 0315 Software

    Preceding Certificates

    CR-03-1230-834-23 Supplemented
    Issued: November 4, 2024 Expires: December 22, 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.