BEUDAMED
    MDR MDR QMS Issued

    1434-MDR-004/2024

    Manufacturer: FREY SPÓŁKA JAWNA
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    1
    Revision
    1 / 19.06.2024 / S/708/BM/2022
    1105
    Valid for 1105 days
    Expiry: June 18, 2029

    Basic Information

    Number
    1434-MDR-004/2024
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 19, 2024
    Expiry Date
    June 18, 2029
    Revision
    1 / 19.06.2024 / S/708/BM/2022
    Manufacturer
    FREY SPÓŁKA JAWNA

    Certificate Lifecycle

    June 19, 2024 June 18, 2029

    Device Characteristics

    Intended Medical Purpose

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class I Measuring Function

    Z1212012003 - PERIPHERAL VISION ANALYSERS

    Quality Procedure Scope

    Device Class I Measuring Function

    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.