BEUDAMED
    MDR MDR QMS Issued

    CSQ000823

    Manufacturer: Fin-ceramica faenza spa
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    642
    Valid for 642 days
    Expiry: March 12, 2028

    Basic Information

    Number
    CSQ000823
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 13, 2023
    Expiry Date
    March 12, 2028
    Revision
    00
    Manufacturer
    Fin-ceramica faenza spa

    Certificate Lifecycle

    March 13, 2023 March 12, 2028

    Device Characteristics

    Sterile Animal Tissues

    Scopes

    4 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class III

    MaioRegen Prime MaioRegen Slim MaioRegen Chondro+

    Quality Procedure Scope

    Device Group Class III

    RegenOss Ortho RegenOss Spine

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Class III

    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.