BEUDAMED
    IVDR IVDR QMS Issued

    HX 2183501-1

    Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    0
    1100
    Valid for 1100 days
    Expiry: June 13, 2029

    Basic Information

    Number
    HX 2183501-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    June 14, 2024
    Expiry Date
    June 13, 2029
    Manufacturer
    Shenzhen Dymind Biotechnology Co., Ltd.

    Certificate Lifecycle

    June 14, 2024 June 13, 2029

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class B

    HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W02020101 - AUTOMATED 5 PART DIFFERENTIAL HEMATOLOGY ANALYSERS W02020102 - LIMITED PANEL CELL COUNTING ANALYSERS HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030105 - HAEMATOLOGY CONTROLS AND CALIBRATORS

    Quality Procedure Scope

    Device Group Class C

    IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021109 - C-REACTIVE PROTEIN W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY

    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.