BEUDAMED
    MDR MDR QMS Issued

    JP24/00000273

    Manufacturer: MIKASA X-RAY Co.,Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    1211
    Valid for 1211 days
    Expiry: October 1, 2029

    Basic Information

    Number
    JP24/00000273
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 1, 2024
    Expiry Date
    October 1, 2029
    Revision
    1
    Manufacturer
    MIKASA X-RAY Co.,Ltd.

    Certificate Lifecycle

    October 1, 2024 October 1, 2029

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    MDA0201, MDS1009, EMDN: Z11039011

    Quality Procedure Scope

    Device Class IIb

    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.