BEUDAMED
    MDR MDR QMS

    US22/00000080

    Manufacturer: Invacare Corporation
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 1
    471
    Valid for 471 days
    Expiry: September 22, 2027

    Basic Information

    Number
    US22/00000080
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 23, 2022
    Expiry Date
    September 22, 2027
    Revision
    Issue 1
    Decision Date
    January 20, 2023
    Manufacturer
    Invacare Corporation

    Certificate Lifecycle

    September 23, 2022 September 22, 2027

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Oxygen Concentrators

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    US22/00000080 Issued
    Issued: September 23, 2022 Expires: September 22, 2027

    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.