BEUDAMED
    MDR MDR QMS Amended

    MDR-003

    Manufacturer: SHL Solutions for Healthcare and Life-Sciences GmbH
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    2
    840
    Valid for 840 days
    Expiry: September 26, 2028

    Basic Information

    Number
    MDR-003
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 18, 2024
    Expiry Date
    September 26, 2028
    Revision
    2
    Manufacturer
    SHL Solutions for Healthcare and Life-Sciences GmbH

    Certificate Lifecycle

    November 18, 2024 September 26, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Various digital bioimaging management instruments - medical device software

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    MDR-003 Issued
    Issued: September 27, 2023 Expires: September 26, 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.