BEUDAMED
    MDR MDR QMS Amended

    ITH 1984728 1

    Manufacturer: Pikdare S.p.A.
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    1
    Revision
    7.0
    328
    Valid for 328 days
    Expiry: May 2, 2027

    Basic Information

    Number
    ITH 1984728 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 4, 2024
    Expiry Date
    May 2, 2027
    Revision
    7.0
    Manufacturer
    Pikdare S.p.A.

    Certificate Lifecycle

    November 4, 2024 May 2, 2027

    Device Characteristics

    Sterile

    Scopes

    4 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Active non-implantable devices for monitoring of vital physiological parameters

    Quality Procedure Scope

    Device Group Class I Sterile

    Non-active non-implantable devices for wound and skin care

    Quality Procedure Scope

    Device Group Class IIa

    Active non-implantable respiratory devices

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

    Preceding Certificates

    ITH 1984728 1 Supplemented
    Issued: July 11, 2024 Expires: May 2, 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.