#744026
Tá SFU comhdhéanta de SF-SFU agus ST-SFU.
The UDI is comprised of the UDI-DI and the UDI-PI.
Filter results
Collections
292 results in 6 documents
#744041
Beidh SFU ina dhá chuid: SF-SFU agus ST-SFU.
The UDI shall contain two parts: a UDI-DI and a UDI-PI.
#747620
Tá SFU comhdhéanta de SF-SFU agus ST-SFU.
The UDI is comprised of the UDI-DI and the UDI-PI.
#747635
Beidh SFU ina dhá chuid: SF-SFU agus ST-SFU.
The UDI shall contain two parts: a UDI-DI and a UDI-PI.
#3007385
Cuimsíonn an SFU sainaitheantóir feiste (SF-SFU) agus sainaitheantóir táirgeachta (ST-SFU).
The UDI comprises a device identifier (UDI-DI) and a production identifier (UDI-PI).
#743973
SF-SFU Bunúsach amhail dá dtagraítear in Airteagal 29 agus aon SF-SFUanna breise,
the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
#744130
Beidh gá le ST-SFU nua ach ní bheidh gá le SF-SFU chun mion-athbhreithnithe a dhéanamh ar bhogearraí.
Minor software revisions shall require a new UDI-PI and not a new UDI-DI.
#747569
i gcás inarb infheidhme, SF-SFU Bunúsach dá dtagraítear in Airteagal 24(6) agus aon SF-SFUanna breise,
the Basic UDI-DI as referred to in Article 24(6) and any additional UDI-DIs,
#747700
Le mion-athbhreithnithe ar bhogearraí, is ST-SFU nua agus ní SF-SFU a bheidh ag teastáil:
Minor software revisions shall require a new UDI-PI and not a new UDI-DI:
#744096
Déanfar feistí so-ionchlannaithe, ar an leibhéal is ísle pacáistithe (“pacáistí aonaid”) a shainaithint, nó cuirfear an mharcáil SGSU orthu le SFU (SF-SFU + ST-SFU);
Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);
#744105
Is é an duine nádúrtha nódlítheanacha in Airteagal 22 a bheidh freagrach as an gcóras nó as an bpacáiste gnáthaimh a shainaithint le SFU lena n-áirítear SF-SFU agus ST-SFU araon.
The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.
#741984
shann an monaróir, i gcás inarb infheidhme, SFU i gcomhréir le hAirteagal 27.
where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
#742006
shann an monaróir, i gcás inarb infheidhme, SFU.
that, where applicable, a UDI has been assigned by the manufacturer.
#742170
SFU a tháirgeadh atá comhdhéanta den mhéid seo a leanas:
production of a UDI that comprises the following:
#742171
sainaitheantóir feiste SFU (“SF-SFU”) a bhaineann go sonrach le monaróir agus le feiste, lena dtugtar rochtain ar an bhfaisnéis a leagtar síos i gCuid B d'Iarscríbhinn VI;
a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
#742172
sainaitheantóir táirgeachta SFU (“ST-SFU”) lena sainaithnítear aonad tháirgeadh na feiste agus, más infheidhme, na feistí pacáistithe, mar a shonraítear iad i gCuid C d'Iarscríbhinn VI;
a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
#742173
SFU a chur ar lipéad na feiste nó ar an bpacáistíocht ina bhfuil sí;
placing of the UDI on the label of the device or on its packaging;
#742175
córas leictreonach a bhunú maidir le Sainaitheantas Feiste Uathúla (“bunachar sonraí SFU”) i gcomhréir le hAirteagal 28.
establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28.
#742205
na sonraí a shonrú a bheidh le háireamh in ST-SFU de chuid feistí sonracha nó de chuid grúpaí feistí;
specifying the data to be included in the UDI-PI of specific devices or device groups;
#742211
cóineasú na gcóras SFU a fhorbraítear ar an leibhéal idirnáisiúnta;
the convergence of UDI systems developed at international level;
#742212
an gá le dúbláil a sheachaint sa chóras SFU;
the need to avoid duplications in the UDI system;
#742215
Bunachar sonraí SFU
UDI database
#742218
Ainmneofar bunachar sonraí SFU go háirithe sa chaoi nach bhféadfar ST-SFU ar bith ná aon fhaisnéis rúnda tráchtála faoi tháirgí a chur isteach ann.
The UDI database shall be designed in particular such that no UDI-PIs and no commercially confidential product information can be included therein.
#742276
bunachar sonraí SFU dá dtagraítear in Airteagal 28;
the UDI-database referred to in Article 28;
#742622
Le deimhniú cirt díola, leagfar amach SF-SFU Bunúsach na feiste a chuirtear isteach i mbunachar sonraí SFU faoi Airteagal 29.
The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29.
#743101
Áireofar sa chóras leictreonach sin naisc ábhartha chuig bunachar sonraí SFU.
That electronic system shall include relevant links to the UDI database.
#743503
VI Faisnéis le cur isteach tráth cláraithe feistí agus oibreoirí eacnamaíocha i gcomhréir le hAirteagal 29(4) agus le hAirteagal 31; buneilimintí sonraí atá le cur isteach sa bhunachar sonraí SFU in éineacht leis an SF-SFU i gcomhréir le hAirteagal 28 agus le hAirteagal 29; agus córas SFU
VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system
#743740
iompróir SFU dá dtagraítear in Airteagal 27(4) agus i gCuid C d'Iarscríbhinn VII;
the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
#743929
SF-SFU Bunúsach dá dtagraítear i gCuid C d'Iarscríbhinn VI;
The Basic UDI-DI as referred to in Part C of Annex VI;
#743944
FAISNÉIS LE TÍOLACADH TRÁTH CLÁRAITHE FEISTÍ AGUS OIBREOIRÍ EACNAMAÍOCHA I gCOMHRÉIR LE hAIRTEAGAL 29(4) AGUS LE hAIRTEAGAL 31, NA BUNEILIMINTÍ SONRAÍ ATÁ LE SOLÁTHAR DO BHUNACHAR SONRAÍ SFU IN ÉINEACHT LE SF-SFU I gCOMHRÉIR LE hAIRTEAGAL 28 AGUS LE hAIRTEAGAL 29, AGUS CÓRAS SFU
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
#743954
An SF-SFU bunúsach,
Basic UDI-DI,
#743970
NA BUNEILIMINTÍ SONRAÍ ATÁ LE SOLÁTHAR DO BHUNACHAR SONRAÍ SFU IN ÉINEACHT LE SF-SFU I gCOMHRÉIR LE hAIRTEAGAL 28 AGUS LE hAIRTEAGAL 29
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29
#743971
Soláthróidh an monaróir SF-SFU do bhunachar sonraí SFU mar aon leis an bhfaisnéis uile seo a leanas a bhaineann leis an monaróir agus leis an bhfeiste:
The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:
#743995
CÓRAS SFU
THE UDI SYSTEM
#743999
SF-SFU Bunúsach
Basic UDI-DI
#744000
Is é is SF-SFU Bunúsach ann príomh-shainaitheantóir múnla feiste.
The Basic UDI-DI is the primary identifier of a device model.
#744014
Cód uimhriúil nó alfa-uimhriúil uathúil is ea SF-SFU, a bhaineann go sonrach le múnla feiste agus a úsáidtear freisin mar an “meán rochtana” ar fhaisnéis atá á stóráil i mbunachar sonraí SFU.
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
#744016
Is é atá in LID léiriú inléite ar na carachtair sonraí atá ionchódaithe in iompróir SFU.
HRI is a legible interpretation of the data characters encoded in the UDI carrier.
#744019
Is cód uimhriúil nó alfa-uimhriúil é ST-SFU lena sainaithnítear aonad tháirgeadh na feiste.
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
#744023
Sainaitheantóir Feiste Uathúla (SFU)
Unique Device Identifier (‘UDI’)
#744028
Iompróir SFU
UDI carrier
#744029
Is éard atá in iompróir SFU an modh lena gcuirtear SFU in iúl trí SGSU a úsáid agus, más infheidhme, a LID.
The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.
#744030
Cuimsítear le hiompróirí SFU, inter alia, barrachód ID/ líneach, barrachód 2D/Maitríse, RFID.
UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
#744034
Is é nó is í an monaróir amháin a fhéadfaidh SFU a chur ar an bhfeiste nó ar phacáistíocht na feiste.
Only the manufacturer may place the UDI on the device or its packaging.
#744036
SFU
The UDI
#744037
Sannfar SFU don fheiste féin nó do phacáistíocht na feiste.
A UDI shall be assigned to the device itself or its packaging.
#744038
Beidh a SFU féin ag leibhéil phacáistíochta níos airde.
Higher levels of packaging shall have their own UDI.
#744040
Mar shampla, ní éilítear SFU ar aonad lóistíochta; i gcás ina n-ordaíonn soláthraí cúraim sláinte an iliomad feistí agus SFU nó uimhir mhúnla feistí aonair á n-úsáid aige nó aici, agus i gcás ina gcuireann an monaróir na feistí sin i gcoimeádán loingseoireachta nó i gcoimeádán chun na feistí atá i bpacáistíocht aonair a chosaint, ní bheidh an coimeádán (aonad lóistíochta) faoi réir ceanglais i dtaca le SFU.
By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
#744042
Beidh SF-SFU uathúil ar gach leibhéal den phacáistíocht feiste.
The UDI-DI shall be unique at each level of device packaging.
#744048
Sannfaidh an monaróir SFU don fheiste agus an caighdeán ábhartha códúcháin á leanúint aige.
The manufacturer shall assign the UDI to a device following the relevant coding standard.