BEUDAMED
    MDR MDR QMS Issued

    TNP/MDR/0025/4478/2024

    Manufacturer: MEDAPP SPÓŁKA AKCYJNA
    Basic UDI-DIs
    0
    Scopes
    5
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    Ver. 01
    456
    Valid for 456 days
    Expiry: September 8, 2027

    Basic Information

    Number
    TNP/MDR/0025/4478/2024
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 9, 2024
    Expiry Date
    September 8, 2027
    Revision
    Ver. 01
    Manufacturer
    MEDAPP SPÓŁKA AKCYJNA

    Certificate Lifecycle

    September 9, 2024 September 8, 2027

    Scopes

    5 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Oprogramowanie umożliwiające przetwarzanie, wizualizację danych w formatach DICOM, STL, OBJ / Software that allows processing,visualization of data in DICOM, STL, OBJ formats

    Quality Procedure Scope

    Device Group Class IIb

    Analityczny system medycyny cyfrowej / Analytic digital medicine system

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIb

    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.