BEUDAMED
    MDR MDR QMS Supplemented

    CN23/00003444

    Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    5
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    3
    750
    Valid for 750 days
    Expiry: June 27, 2028

    Basic Information

    Number
    CN23/00003444
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    January 10, 2024
    Expiry Date
    June 27, 2028
    Revision
    3
    Manufacturer
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

    Certificate Lifecycle

    January 10, 2024 June 27, 2028

    Device Characteristics

    Sterile

    Scopes

    5 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIa

    MDA0306, MDs1009, MDS1005

    Quality Procedure Scope

    Device Group Class IIb

    MDA0312 EMDN K020199

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    CN23/00003444 Supplemented
    Issued: August 16, 2023 Expires: June 27, 2028

    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.