BEUDAMED
    MDR MDR QMS Issued

    MDR-0016

    Manufacturer: Optotek d.o.o.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    1195
    Valid for 1195 days
    Expiry: September 15, 2029

    Basic Information

    Number
    MDR-0016
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 16, 2024
    Expiry Date
    September 15, 2029
    Revision
    1
    Manufacturer
    Optotek d.o.o.

    Certificate Lifecycle

    September 16, 2024 September 15, 2029

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Neodymium surgical laser

    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.