BEUDAMED
    MDR MDR QMS Issued

    HZ 2159866-1

    Manufacturer: Shandong Lee Med Technology Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    916
    Valid for 916 days
    Expiry: December 10, 2028

    Basic Information

    Number
    HZ 2159866-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 11, 2023
    Expiry Date
    December 10, 2028
    Manufacturer
    Shandong Lee Med Technology Co., Ltd.

    Certificate Lifecycle

    December 11, 2023 December 10, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    A03010102 - INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS) A03010105 - INFUSION PUMP CONTROLLERS A030201 - EXTENSIONS

    Quality Procedure Scope

    Device Group Class I Sterile

    A03010103 - INFUSION CONTROLLERS WITH FLOW REGULATOR A0704 - SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS T020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR

    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.