BEUDAMED
    MDR MDR QMS Issued

    FI24/00000061

    Manufacturer: Optomed Oyj
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 1
    1093
    Valid for 1093 days
    Expiry: June 5, 2029

    Basic Information

    Number
    FI24/00000061
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 6, 2024
    Expiry Date
    June 5, 2029
    Revision
    Issue 1
    Manufacturer
    Optomed Oyj

    Certificate Lifecycle

    September 6, 2024 June 5, 2029

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Z121201 Ophthalmology assessment and diagnosis instrument

    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.