BEUDAMED
    MDR MDR QMS Issued

    ITH 1343916 1

    Manufacturer: AFERETICA S.R.L.
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    1.0
    1226
    Valid for 1226 days
    Expiry: October 17, 2029

    Basic Information

    Number
    ITH 1343916 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 18, 2024
    Expiry Date
    October 17, 2029
    Revision
    1.0
    Manufacturer
    AFERETICA S.R.L.

    Certificate Lifecycle

    October 18, 2024 October 17, 2029

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Dispositivi non impiantabili attivi per il trattamento e la conservazione di cellule, tessuti o organi umani comprese fecondazione in vitro e tecnologie di riproduzione assistita / Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)

    Quality Procedure Scope

    Device Group Class I Sterile

    Altri dispositivi non impiantabili attivi / Other active non-implantable devices

    Quality Procedure Scope

    Device Group Class IIa

    Dispositivi non impiantabili non attivi per il trattamento e la conservazione di cellule, tessuti o organi umani comprese fecondazione in vitro e tecnologie di riproduzione assistita / Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

    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.