BEUDAMED
    MDR MDR QMS Issued

    HZ 2011531-1

    Manufacturer: Zhejiang Eksen Medical Technology Co.,Ltd.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    1219
    Valid for 1219 days
    Expiry: October 10, 2029

    Basic Information

    Number
    HZ 2011531-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 11, 2024
    Expiry Date
    October 10, 2029
    Manufacturer
    Zhejiang Eksen Medical Technology Co.,Ltd.

    Certificate Lifecycle

    October 11, 2024 October 10, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class IIa

    Q010403 - ORTHODONTIC BRACKETS AND BUTTONS Q010405 - ORTHODONTIC WIRES Q010406 - ORTHODONTIC LIGATURES

    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.