#742256
sainaitheantas na feiste agus an mhonaróra, lena n-áirítear SF-SFU Bunúsach agus SRN;
the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
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#743977
SRN i gcomhréir le hAirteagal 31(2),
the SRN issued in accordance with Article 31(2),
#744958
má eisíodh sin cheana féin, SRN an mhonaróra dá dtagraítear in Airteagal 31(2);
if already issued, the SRN of the manufacturer referred to in to Article 31(2);
#747573
SRN a eisíodh i gcomhréir le hAirteagal 28(2),
the SRN issued in accordance with Article 28(2),
#748411
má tá sé eisithe cheana féin, SRN an mhonaróra dá dtagraítear in Airteagal 28(2);
if already issued, the SRN of the manufacturer referred to in Article 28(2);
#746015
sainaitheantas na feiste agus an mhonaróra, lena n-áirítear an SF-SFU Bunúsach agus, má tá sé eisithe cheana féin, an SRN;
the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
#742240
Tar éis don údarás inniúil na sonraí a thíolactar de bhun mhír 1 a fhíorú, gheobhaidh an t-údarás inniúil uimhir aonair chlárúcháin (“SRN”) as an gcóras leictreonach dá dtagraítear in Airteagal 30 agus eiseoidh sé don mhonaróir, don ionadaí údaraithe nó don allmhaireoir í.
After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.
#742241
Úsáidfidh an monaróir SRN nuair a chuirfidh sé iarratas ar mheasúnú comhréireachta isteach chuig comhlacht dá dtugtar fógra agus chun rochatain a fháil ar Euramed chun a chuid oibleagáidí faoi Airteagal 29 a chomhlíonadh.
The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.
#743927
Ainm, trádainm cláraithe nó trádmharc cláraithe an mhonaróra agus, má eisíodh cheana féin í, SRN dá dtagraítear in Airteagal 31 agus, más infheidhme, a ionadaí údaraithe, seoladh a n-áite gnó cláraithe mar ar féidir dul i dteagmháil leo agus an áit ina bhfuil siad lonnaithe a shuí;
Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
#745999
Tar éis don údarás inniúil na sonraí a cuireadh isteach de bhun mhír 1 a fhíorú, gheobhaidh an t-údarás inniúil uimhir clárúcháin aonair (“SRN”) ón gcóras leictreonach dá dtagraítear in Airteagal 27 agus eiseoidh sé don mhonaróir, don ionadaí údaraithe nó don allmhaireoir í.
After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer.
#746000
Úsáidfidh an monaróir an SRN nuair a chuirfidh sé iarratas ar mheasúnú comhréireachta agus ar rochtain ar Eudamed isteach chuig comhlacht dá dtugtar fógra chun a chuid oibleagáidí faoi Airteagal 26 a chomhlíonadh.
The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 26.
#746781
Leis an bhfógra um shábháilteacht allamuigh, beifear in ann an fheiste nó na feistí atá i gceist a shainaithint go cruinn, go háirithe trí na SFUanna ábhartha a áireamh, agus an monaróir a rinne an ghníomhaíocht cheartaitheach um shábháilteacht allamuigh a shainaithint go cruinn, go háirithe tríd an SRN a áireamh, má tá sé eisithe cheana féin.
The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action.
#747521
Ainm, trádainm cláraithe nó trádmharc cláraithe an mhonaróra agus, má tá sé eisithe cheana féin, SRN dá dtagraítear in Airteagal 28 agus, más infheidhme, a ionadaí údaraithe, seoladh a n-áite cláraithe gnó mar ar féidir dul i dteagmháil leo agus an áit ina bhfuil siad lonnaithe a shuí;
Name, registered trade name or registered trade mark and, if already issued, SRN referred to in Article 28 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;