BEUDAMED
    MDR MDR QMS Issued

    FI24/00000064

    Manufacturer: Fiagon GmbH
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 1
    1237
    Valid for 1237 days
    Expiry: October 27, 2029

    Basic Information

    Number
    FI24/00000064
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 28, 2024
    Expiry Date
    October 27, 2029
    Revision
    Issue 1
    Manufacturer
    Fiagon GmbH

    Certificate Lifecycle

    October 28, 2024 October 27, 2029

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Z12011401 Surgical Navigation System

    Quality Procedure Scope

    Device Class IIa

    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.