BEUDAMED
    MDR MDR QMS Supplemented

    ITH 1450762 1

    Manufacturer: Sky Medical a.s.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    2.0
    532
    Valid for 532 days
    Expiry: November 22, 2027

    Basic Information

    Number
    ITH 1450762 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 6, 2024
    Expiry Date
    November 22, 2027
    Revision
    2.0
    Manufacturer
    Sky Medical a.s.

    Certificate Lifecycle

    June 6, 2024 November 22, 2027

    Device Characteristics

    Sterile

    Conditions

    English

    The scope of certification is limited to the aspects relating to establishing, securing and maintaining device sterile conditions

    Italian

    Lo scopo della certificazione è limitato agli aspetti relativi alla dimostrazione, al raggiungimento e al mantenimento dello stato sterile dei dispositivi

    Scopes

    Quality Procedure Scope

    Device Group Class IIb

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

    Preceding Certificates

    ITH 1450762 1 Issued
    Issued: September 11, 2023 Expires: November 22, 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.