BEUDAMED
    IVDR IVDR QMS Issued

    HX 1108389-1

    Manufacturer: biocyc Biotechnologie GmbH & Co. KG
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.0
    1107
    Valid for 1107 days
    Expiry: June 20, 2029

    Basic Information

    Number
    HX 1108389-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    June 21, 2024
    Expiry Date
    June 20, 2029
    Revision
    Rev.0
    Manufacturer
    biocyc Biotechnologie GmbH & Co. KG

    Certificate Lifecycle

    June 21, 2024 June 20, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01030709 - PRIMARY ANTISERA FOR IMMUNOHISTOLOGY

    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.