BEUDAMED
    MDR MDR QMS Issued

    2022-MDR/QS-021

    Manufacturer: FOTONA, proizvodnja optoelektronskih naprav d.o.o.
    Basic UDI-DIs
    0
    Scopes
    6
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    470
    Valid for 470 days
    Expiry: September 21, 2027

    Basic Information

    Number
    2022-MDR/QS-021
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 21, 2022
    Expiry Date
    September 21, 2027
    Revision
    00
    Manufacturer
    FOTONA, proizvodnja optoelektronskih naprav d.o.o.

    Certificate Lifecycle

    September 21, 2022 September 21, 2027

    Scopes

    6 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Magnetic therapy devices

    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.