BEUDAMED
    MDR MDR QMS Issued

    ITH 2409169 1

    Manufacturer: Roncadelle Operations Srl
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    1.0
    412
    Valid for 412 days
    Expiry: July 25, 2027

    Basic Information

    Number
    ITH 2409169 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 26, 2022
    Expiry Date
    July 25, 2027
    Revision
    1.0
    Manufacturer
    Roncadelle Operations Srl

    Certificate Lifecycle

    July 26, 2022 July 25, 2027

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Class I Sterile

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa Class I Sterile

    Dispositivi non impiantabili non attivi per la somministrazione la canalizzazione e la sottrazione di sostanze, compresi i dispositivi per dialisi / Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

    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.