BEUDAMED
    MDR MDR QMS Amended

    FI24/00000055

    Manufacturer: Vitec Codea Oy
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 2
    451
    Valid for 451 days
    Expiry: September 2, 2027

    Basic Information

    Number
    FI24/00000055
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 25, 2024
    Expiry Date
    September 2, 2027
    Revision
    Issue 2
    Manufacturer
    Vitec Codea Oy

    Certificate Lifecycle

    November 25, 2024 September 2, 2027

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Medical software for emergency patient care reporting V92 medical device SW - not included in other classes

    Preceding Certificates

    FI24/00000055 Issued
    Issued: September 3, 2024 Expires: September 2, 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.