BEUDAMED
    MDR MDR QMS Supplemented

    ITH 1024597 1

    Manufacturer: Asensus Surgical Italia S.r.l.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    4.0
    386
    Valid for 386 days
    Expiry: June 30, 2027

    Basic Information

    Number
    ITH 1024597 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 16, 2024
    Expiry Date
    June 30, 2027
    Revision
    4.0
    Manufacturer
    Asensus Surgical Italia S.r.l.

    Certificate Lifecycle

    July 16, 2024 June 30, 2027

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIb Class IIa

    Other active non-implantable surgical devices

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable instruments

    Preceding Certificates

    ITH 1024597 1 Amended
    Issued: April 30, 2024 Expires: June 30, 2027

    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.