#2945755
Scór ceanglóirí (cineál) (SF) agus scór Uirlisí (cineál) (ST)
Fasteners (type) score (SF) and Tools (type) score (ST)
Scag na torthaí
Bailiúcháin
158 toradh in 27 doiciméad
#2946139
Is é (SF) an scór ‘Ceanglóirí’ (cineál)
Fasteners (type) score (SF)
#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).
#3007387
Tá SF-SFU le sannadh do mhúnla sonrach feiste agus do mhonaróir sonrach.
A UDI-DI is to be assigned to a specific model of device and manufacturer.
#3123923
Ullmhóid de Saccharomyces cerevisiae DBVPG 48 SF le híostiúchan:
Preparation of Saccharomyces cerevisiae DBVPG 48 SF with a minimum concentration of:
#3123927
Cealla inmharthana Saccharomyces cerevisiae DBVPG 48 SF.
Viable cells of Saccharomyces cerevisiae DBVPG 48 SF.
#3131307
Minicíocht samplála (SF) n =
Sampling frequency (SF) n =
#3132080
Minicíocht samplála (SF) n =
Sampling frequency (SF) n =
#3257436
Féach, mar shampla, Tools for growth – on Innovation Norway and Siva SF, 2012.
See, for instance, Tools for growth – on Innovation Norway and Siva SF, 2012.
#3257442
Ciallaíonn SF nó Statsforetak Fiontar Stáit, cineál cuideachta san Iorua.
SF or Statsforetak mean State Enterprise, a type of company in Norway.
#744049
Ceanglófar SF-SFU nua aon uair a tharlóidh athrú a bhféadfaí an fheiste a shainaithint go mícheart mar gheall air agus/nó a bhféadfadh débhríocht ina hinrianaitheacht a bheith mar thoradh air; go háirithe má dhéantar aon athrú ar cheann de na heilimintí sonraí seo a leanas i mbunachar sonraí SFU, ceanglófar SF-SFU nua:
A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
#745330
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.
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.
#2177565
SF-SFU Bunúsach (sainaithint uathúil feiste-sainaitheantóir feiste) agus/nó SF-SFU na feiste, dá dtagraítear faoi seach in Airteagal 27(6) agus Airteagal 27(1), pointe (a)(i), de Rialachán (AE) 2017/745, agus aon fhaisnéis bhreise lenar féidir an fheiste a shainaithint, lena n-áirítear a hainm agus, más infheidhme, an tsamhail;
the Basic UDI-DI and/or the UDI-DI of the device, as respectively referred to in Article 27(6) and Article 27(1), point (a)(i), of Regulation (EU) 2017/745, and any additional information allowing the identification of the device, including its name and if applicable the model;
#3007390
Maidir leis an indibhidiúlú sin ar leibhéal na SF-SFUnna a bhfuil iomadú SF-SFUnna atá le sannadh do lionsaí tadhaill comhchosúla mar thoradh air, cruthaíonn an t-indibhidiúlú sin an iomarca oibre do Eudamed agus tá sé díréireach i gcomparáid leis an riosca sábháilteachta a bhaineann le lionsaí tadhaill.
This individualisation at UDI-DI level, that results in a proliferation of UDI-DIs to be assigned to similar contact lenses, overwhelms Eudamed and is disproportionate compared to the safety risk associated with contact lenses.
#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;
#742192
SF-SFU Bunúsach, mar a shainítear é i gCuid C d'Iarscríbhinn VI, de chuid na feiste, beidh sé le feiceáil ar dhearbhú comhréireachta AE dá dtagraítear in Airteagal 19.
The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of conformity referred to in Article 19.
#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.
#743931
Seachas ainm an táirge nó an trádainm, féadfar an fhaisnéis lena gceadaítear sainaithint agus inrianaitheacht a chur ar fáil trí SF-SFU Bunúsach dá dtagraítear i bpointe 3;
Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
#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:
#744065
Má úsáidtear barrachóid líneacha, féadfar SF-SFU agus ST-SFU a chomhchaitéiniú nó a neamh-chomhchaitéiniú ina dhá mbarrachód nó níos mó.
If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes.
#744080
I gcás iompróirí barrachóid lena gcuimsítear SF-SFU agus ST-SFU araon, féadfaidh sonraí bunriachtanacha a bheith iontu freisin ionas go n-oibreoidh an fheiste nó sonraí eile.
Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.
#744086
Má tá SF-SFU na feiste i mbunachar sonraí SFU, ní ghlacfar leis go gciallaíonn sé sin go bhfuil an fheiste i gcomhréir leis an Rialachán seo.
The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
#744088
Beidh na sonraí i ndáil le SF-SFU nua ar fáil tráth a gcuirfear an fheiste ar an margadh.
The data for new UDI-DIs shall be available at the time the device is placed on the market.
#744089
Déanfaidh monaróirí taifead ar bhunachar sonraí SFU ábhartha a nuashonrú laistigh de 30 tar éis athrú a dhéanamh ar eilimint nach gá SF-SFU nua lena haghaidh.
Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require 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);
#744115
Sannfar SF-SFU na feiste inchumraithe ar ghrúpaí cumraíochtaí, seachas in aghaidh na cumraíochta laistigh den ghrúpa.
The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group.
#744125
Beidh SF-SFU nua ag teastáil aon uair a mbeidh modhnú ann as a dtiocfaidh athruithe ar na nithe seo a leanas:
A new UDI-DI shall be required whenever there is a modification that changes:
#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.
#745937
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;
#745958
An SF-SFU Bunúsach de chuid na feiste, mar a shainítear é i gCuid C d'Iarscríbhinn VI, beidh sé le feiceáil ar dhearbhú comhréireachta AE dá dtagraítear in Airteagal 17.
The Basic UDI-DI, as defined in Part C of Annex VI of the device shall appear on the EU declaration of conformity referred to in Article 17.
#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;
#746356
Le deimhniú cirt díola, leagfar amach SF-SFU Bunúsach an fheiste mar a soláthraíodh don bhunachar sonraí SFU é faoi Airteagal 26.
The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 26.
#747525
Seachas ainm an táirge nó an trádainm, féadfar an fhaisnéis lena gceadaítear sainaithint agus inrianaitheacht a chur ar fáil trí SF-SFU Bunúsach dá dtagraítear i bpointe 3;
Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
#747566
NA BUNEILIMINTÍ SONRAÍ ATÁ LE SOLÁTHAR DON BHUNACHAR SONRAÍ SFU IN ÉINEACHT LE SF-SFU I GCOMHRÉIR LE LE HAIRTEAGAL 25 AGUS LE HAIRTEAGAL 26
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26
#747567
Cuirfidh an monaróir SF-SFU ar fáil do bhunachar sonraí SFU mar aon leis an bhfaisnéis seo a leanas a bhaineann leis an monaróir agus leis an bhfeiste:
The manufacturer shall provide to the UDI database the UDI-DI and the following information relating to the manufacturer and the device:
#747643
Ceanglófar SF-SFU nua aon uair a dhéantar athrú a bhféadfaí an fheiste a shainaithint go mícheart mar gheall air agus/nó a bhféadfadh débhríocht ina inrianaitheacht a bheith mar thoradh air.
A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability.
#747644
Go háirithe, éileofar SF-SFU nua le haon athrú a dhéanfar ar aon cheann d'eilimintí sonraí bhunachar sonraí SFU seo a leanas:
In particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
#747660
Má úsáidtear barrachóid líneacha, féadfar SF-SFU agus ST-SFU a chomhchaitéiniú nó a neamh-chomhchaitéiniú ina dhá bharrachód nó níos mó.
If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes.
#747672
I gcás na n-iompróirí barrachóid lena gcuimsítear “SF-SFU” agus “ST-SFU” araon, féadfaidh sonraí bunriachtanacha a bheith iontu freisin ionas go n-oibreoidh an fheiste nó sonraí eile.
Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.
#747678
Má tá SF-SFU na feiste i mbunachar sonraí SFU, ní ghlacfar leis go gciallaíonn sé sin go bhfuil an fheiste i gcomhréir leis an Rialachán seo.
The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
#747680
Beidh na sonraí i ndáil le SF-SFU nua ar fáil tráth a gcuirfear an fheiste ar an margadh.
The data for new UDI-DIs shall be available at the time the device is placed on the market.
#747681
Déanfaidh monaróirí taifead bhunachar sonraí SFU ábhartha a nuashonrú laistigh de 30 tar éis athrú a bheith déanta ar eilimint nach gá SF-SFU nua dó.
Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.
#747695
Beidh SF-SFU nua ag teastáil aon uair a mbeidh modhnú ann as a dtiocfaidh athruithe ar na nithe seo a leanas:
A new UDI-DI shall be required whenever there is a modification that changes:
#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:
#1796960
SF FX = fachtóir maoirseachta na catagóire priacail malairte eachtraí ag a bhfuil luach atá cothrom le 4 %;
SF FX = the supervisory factor for the foreign exchange risk category with a value equal to 4 %;
#1799933
SF IR = fachtóir maoirseachta na catagóire priacail ráta úis ag a bhfuil luach atá cothrom le 0,5 %;
SF IR = the supervisory factor for the interest rate risk category with a value equal to 0,5 %;
#2305867
I gcás criosanna a bhfuil SF-BTV luaite leo i gcolún 7 den tábla i gCuid 1 d’Iarscríbhinn II a ghabhann le Rialachán Cur Chun Feidhme (AE) 2021/404.
For zones with entry SF-BTV in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.
#2305868
I gcás criosanna a bhfuil SF-EHD luaite leo i gcolún 7 den tábla i gCuid 1 d’Iarscríbhinn II a ghabhann le Rialachán Cur Chun Feidhme (AE) 2021/404.
For zones with entry SF-EHD in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.
#2341926
I gcás criosanna a bhfuil SF-BTV luaite leo i gcolún 7 den tábla i gCuid 1 d’Iarscríbhinn II a ghabhann le Rialachán Cur Chun Feidhme (AE) 2021/404.
For zones with entry SF-BTV in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.