For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
Maidir leis na feistí da dtagraitear sa chéad fhomhír, déanfaidh an comhlacht dá dtugtar fógra tagairt do SF-SFU Bunúsach ar an deimhniú a eisíodh i gcomhréir le pointe 4(a) de Roinn 1 de Chaibidil I d'Iarscríbhinn XII agus dá dtagraítear i Roinn 2.2 de Chuid A d'Iarscríbhinn VI agus dearbhóidh sé in Eudamed go bhfuil an fhaisneis dá dtagraítear in Roinn 2.22 de chuid A d'Iarscíbhinn VI ceart.Tar éis eisiúint an deimhnithe ábhartha agus sula gcuirfear an fheiste ar an margadh, déanfaidh an monaróir SF-SFU Bunúsach, mar aon leis na buneilimintí sonraí eile dá dtagraítear i gCuid B d'Iarscríbhinn VI a bhaineann leis an bhfeiste sin, a sholáthar do bhunachar sonraí SFU.