BEUDAMED
    MDR MDR QMS Issued

    TNP/MDR/0022/5296/2024

    Manufacturer: Onwelo Sp. z o.o.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Ver. 01
    398
    Valid for 398 days
    Expiry: July 11, 2027

    Basic Information

    Number
    TNP/MDR/0022/5296/2024
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 12, 2024
    Expiry Date
    July 11, 2027
    Revision
    Ver. 01
    Manufacturer
    Onwelo Sp. z o.o.

    Certificate Lifecycle

    July 12, 2024 July 11, 2027

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Oprogramowanie do wizualizacji, analizy i opisu danych obrazowych TK, MRI i RTG. / Software for visualization, analysis and description of X-ray, CT and MRI imag

    Quality Procedure Scope

    Device Class IIa

    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.