BEUDAMED
    MDR MDR QMS Supplemented

    FI23/0000004

    Manufacturer: Planmed Oy
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 3
    229
    Valid for 229 days
    Expiry: January 23, 2027

    Basic Information

    Number
    FI23/0000004
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 13, 2024
    Expiry Date
    January 23, 2027
    Revision
    Issue 3
    Manufacturer
    Planmed Oy

    Certificate Lifecycle

    February 13, 2024 January 23, 2027

    Conditions

    English

    PMCF investigation to be planned and conducted for Planmed Verity image processing algorithms

    Scopes

    4 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Z11030202: Diagnostic X-ray equipment and accessories

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Z110306: Computed tomographs (ct)

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    FI23/0000004 Supplemented
    Issued: December 4, 2023 Expires: January 23, 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.