BEUDAMED
    MDR MDR QMS Supplemented

    CSQ0005230223

    Manufacturer: SILDEHA Pharma Srl
    Basic UDI-DIs
    0
    Scopes
    6
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    02
    589
    Valid for 589 days
    Expiry: January 18, 2028

    Basic Information

    Number
    CSQ0005230223
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 7, 2023
    Expiry Date
    January 18, 2028
    Revision
    02
    Manufacturer
    SILDEHA Pharma Srl

    Certificate Lifecycle

    February 7, 2023 January 18, 2028

    Scopes

    6 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    T-LYSYAL® CREMA MUCOSA NASALE, NON STERILE T-LYSYAL® CREAM FOR NASAL MUCOSA, NON STERILE rinoLYSYAL® RINOTE® LysOTIS®

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    T-LysYal® Crema Proctologica T-LysYal® Proctological Cream ProctaLys® proctoLYSYAL® RAGALGIN®

    Quality Procedure Scope

    Device Group Class IIb

    repaLYSYAL® LysaFix® tenderLYSYAL TROSYD® REPAIR KELOREPAIR®

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    CSQ0005230123 Supplemented
    Issued: January 19, 2023 Expires: January 18, 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.