{"id":21529,"date":"2025-03-20T08:25:24","date_gmt":"2025-04-17T09:45:05","guid":{"rendered":"https:\/\/www.ufi.eu\/pcn\/Bez kategorije\/pcn-ufi-za-druge-medicinske-uredaje\/"},"modified":"2025-04-17T09:45:05","modified_gmt":"2025-04-17T09:45:05","slug":"pcn-ufi-za-druge-medicinske-uredaje","status":"publish","type":"product","link":"https:\/\/www.ufi.eu\/hr\/product\/pcn-ufi-za-druge-medicinske-uredaje\/","title":{"rendered":"PCN &amp; UFI za druge medicinske ure\u0111aje"},"content":{"rendered":"<h2>Kako funkcionira usluga kreiranja UFI-ja i PCN obavijesti?<\/h2>\n<p>Nakon kupnje ove usluge dobit \u0107ete pristup sigurnom portalu. Ovaj portal sadr\u017ei pregled svih koraka.  Ispunite podatke o proizvodu i mi \u0107emo se baciti na posao.<\/p>\n<h3>Obavijest i UFI Centra za otrove<\/h3>\n<p>Osigurat \u0107emo:<\/p>\n<ul>\n<li>Jedinstveni identifikator formule (UFI) va\u0161eg proizvoda<\/li>\n<li>Izvje\u0161\u0107e Centra za otrovanje (PCN).<\/li>\n<li>Registracija va\u0161eg proizvoda pri relevantnim nacionalnim centrima za otrovanja putem ECHA-e.<\/li>\n<\/ul>\n<h3>Zemlje za PCN registraciju<\/h3>\n<p>Mo\u017eete ra\u010dunati u koliko zemalja \u017eelite registrirati svoj proizvod. Ovo je broj zemalja koje trebate kupiti.  Na portalu \u0107ete mo\u0107i odabrati odre\u0111ene zemlje. Ako kasnije planirate pro\u0161iriti prodaju svojih proizvoda na nove zemlje, uvijek mo\u017eete naru\u010diti dodatne <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/zemlje\/zemlje-za-pcn-registraciju\/\" target=\"_blank\" title=\"PCN registracije zemalja\">registracije PCN zemalja<\/a> .<br \/> EU ima 27 zemalja, a EEA 30 (EU+Lichtenstein, Norve\u0161ka i Island) Na portalu mo\u017eete odabrati ove zemlje: <\/p>\n<table cellpadding=\"2\" cellspacing=\"0\" border=\"1\">\n<tbody>\n<tr>\n<td>Belgija<\/td>\n<td>(BITI)<\/td>\n<td>\u0160panjolska<\/td>\n<td>(ES)<\/td>\n<td>Ma\u0111arska<\/td>\n<td>(HU)<\/td>\n<td>Slova\u010dka<\/td>\n<td>(SK)<\/td>\n<\/tr>\n<tr>\n<td>Bugarska<\/td>\n<td>(BG)<\/td>\n<td>Francuska<\/td>\n<td>(FR)<\/td>\n<td>Malta<\/td>\n<td>(MT)<\/td>\n<td>Finska<\/td>\n<td>(FI)<\/td>\n<\/tr>\n<tr>\n<td>\u010ce\u0161ka<\/td>\n<td>(CZ)<\/td>\n<td>Hrvatska<\/td>\n<td>(HR)<\/td>\n<td>Nizozemska<\/td>\n<td>(NL)<\/td>\n<td>\u0160vedska<\/td>\n<td>(SE)<\/td>\n<\/tr>\n<tr>\n<td>Danska<\/td>\n<td>(DK)<\/td>\n<td>Italija<\/td>\n<td>(TO)<\/td>\n<td>Austrija<\/td>\n<td>(NA)<\/td>\n<td>Njema\u010dka<\/td>\n<td>(DE)<\/td>\n<\/tr>\n<tr>\n<td>Cipar<\/td>\n<td>(CY)<\/td>\n<td>Poljska<\/td>\n<td>(PL)<\/td>\n<td>Island<\/td>\n<td>(JE)<\/td>\n<td>Estonija<\/td>\n<td>(EE)<\/td>\n<\/tr>\n<tr>\n<td>Latvija<\/td>\n<td>(LV)<\/td>\n<td>Portugal<\/td>\n<td>(PT)<\/td>\n<td>Lihten\u0161tajn<\/td>\n<td>(LI)<\/td>\n<td>Irska<\/td>\n<td>(IE)<\/td>\n<\/tr>\n<tr>\n<td>Litva<\/td>\n<td>(LT)<\/td>\n<td>Rumunija<\/td>\n<td>(RO)<\/td>\n<td>Norve\u0161ka<\/td>\n<td>(NE)<\/td>\n<td>Gr\u010dka<\/td>\n<td>(EL)<\/td>\n<\/tr>\n<tr>\n<td>Luksemburg<\/td>\n<td>(LU)<\/td>\n<td>Slovenija<\/td>\n<td>(SI)<\/td>\n<td>\u0160vicarska*<\/td>\n<td>(CH)<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>*Za \u0160vicarsku mo\u017eemo izraditi PCN dosje, sa svim potrebnim informacijama za podno\u0161enje na \u0161vicarskom portalu. Kontaktirajte nas za vi\u0161e informacija. <\/p>\n<h3>Informacije o oznaci CLP<\/h3>\n<p>Nudimo mogu\u0107nost kupnje naljepnice proizvoda uskla\u0111ene s CLP-om, koja sadr\u017ei sve obvezne podatke kako zahtijeva EU CLP Uredba. Ovo \u0107e biti dostavljeno kao PDF.  Ovo nije dizajn, ve\u0107 sa\u017eetak potrebnih informacija. To \u0107e vam omogu\u0107iti da integrirate potrebne informacije u dizajn naljepnice proizvoda. <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/clp-oznaka\/izrada-clp-oznake-i-provjera-sukladnosti\/\" target=\"_blank\" title=\"CLP labelcCreation\">Izradu CLP naljepnice<\/a> mo\u017eete naru\u010diti i zasebno. Ve\u0107 imate etiketu? \u2014 Mo\u017eemo izvr\u0161iti <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/clp-oznaka\/izrada-clp-oznake-i-provjera-sukladnosti\/\" target=\"_blank\" title=\"Provjera sukladnosti naljepnice CLP\">provjeru uskla\u0111enosti naljepnice s CLP-om<\/a> na va\u0161oj naljepnici u skladu s trenuta\u010dnim zahtjevima CLP-a. Pru\u017eit \u0107emo detaljne povratne informacije i ispravke kako bismo osigurali da va\u0161a oznaka zadovoljava sve regulatorne standarde.     <\/p>\n<h2>Obavijest Centra za otrovanja za druge medicinske ure\u0111aje<\/h2>\n<p>Ostali medicinski ure\u0111aji, koji ne spadaju u posebne kategorije kao \u0161to su proizvodi za \u010di\u0161\u0107enje ili dezinfekciju, i dalje moraju biti u skladu s propisima EU-a kada sadr\u017ee opasne tvari. Kako bi se osiguralo da hitne slu\u017ebe i zdravstveni radnici mogu brzo djelovati u slu\u010daju izlo\u017eenosti ili trovanja, potrebna je obavijest Centra za otrovanja (PCN). Podno\u0161enjem PCN-a proizvo\u0111a\u010di pru\u017eaju klju\u010dne sigurnosne informacije o kemijskim komponentama u svojim medicinskim ure\u0111ajima, poma\u017eu\u0107i u za\u0161titi zdravlja i sigurnosti korisnika i pacijenata.  <\/p>\n<h3>\u0160to je UFI?<\/h3>\n<p>Jedinstveni identifikator formule (UFI) kod je koji se koristi za identifikaciju specifi\u010dnih formulacija kemikalija unutar proizvoda. Za medicinske ure\u0111aje, UFI se koristi za pru\u017eanje hitnih slu\u017ebi s detaljnim informacijama o kemijskom sadr\u017eaju specifi\u010dnim za proizvod. To omogu\u0107uje osobama koje reagiraju da identificiraju to\u010dnu smjesu i poduzmu odgovaraju\u0107e mjere u slu\u010daju nu\u017ede.  <\/p>\n<h3>\u0160to je PCN?<\/h3>\n<p>Obavijest centra za otrove (PCN) je izvje\u0161\u0107e koje su proizvo\u0111a\u010di du\u017eni dostaviti centrima za otrovanja. Sadr\u017ei klju\u010dne informacije o opasnim svojstvima proizvoda, uklju\u010duju\u0107i kemikalije koje se koriste u medicinskim ure\u0111ajima. PCN uklju\u010duje klasifikacije opasnosti, mjere prve pomo\u0107i i druge pojedinosti o hitnom odgovoru. Ove su informacije klju\u010dne za zdravstvene djelatnike i slu\u017ebe za hitne slu\u010dajeve za u\u010dinkovito upravljanje incidentima izlo\u017eenosti kemikalijama.   <\/p>\n<h3>\u0160to je CLP?<\/h3>\n<p>Uredba o razvrstavanju, ozna\u010davanju i pakiranju (CLP) utvr\u0111uje kriterije za razvrstavanje kemijskih tvari i smjesa. Osigurava da su proizvodi, uklju\u010duju\u0107i medicinske ure\u0111aje koji sadr\u017ee opasne tvari, jasno ozna\u010deni simbolima opasnosti, izjavama o mjerama opreza i uputama za prvu pomo\u0107. CLP pru\u017ea standardizirani na\u010din komuniciranja kemijskih opasnosti diljem EU-a, osiguravaju\u0107i sigurnost i svijest na svim razinama.  <\/p>\n<h3>\u0160to je Centar za otrovanja?<\/h3>\n<p>Centar za otrovanje mre\u017ea je nacionalnih centara za kontrolu trovanja koji prikupljaju, obra\u0111uju i pru\u017eaju informacije o opasnim kemikalijama. Proizvo\u0111a\u010di opasnih medicinskih ure\u0111aja moraju registrirati svoje proizvode u Centru za otrovanja kako bi se sigurnosne informacije mogle podijeliti s pru\u017eateljima zdravstvenih usluga i hitnim slu\u017ebama. To osigurava brzu i koordiniranu reakciju u slu\u010daju izlaganja kemikalijama.  <\/p>\n<h3>Za\u0161to je ovo potrebno?<\/h3>\n<p>Medicinski ure\u0111aji mogu sadr\u017eavati kemijske tvari koje predstavljaju rizik za korisnike ili pacijente ako im se slu\u010dajno izlo\u017ee. Podno\u0161enje PCN-a poma\u017ee osigurati da hitne slu\u017ebe i zdravstveni radnici imaju neposredan pristup kriti\u010dnim sigurnosnim informacijama u slu\u010daju izlo\u017eenosti. Ovaj brzi pristup mo\u017ee napraviti razliku u sprje\u010davanju ili smanjenju \u0161tete, osiguravaju\u0107i da se medicinski ure\u0111aji koriste sigurno.  <\/p>\n<h3>Od kada je to po zakonu obavezno?<\/h3>\n<p>Od 1. sije\u010dnja 2021. zakonska je obveza za proizvo\u0111a\u010de medicinskih ure\u0111aja koji sadr\u017ee opasne kemikalije da dostave Obavijest centru za otrovanje (PCN). Obveza proizlazi iz Uredbe EU CLP, \u010diji je cilj pobolj\u0161ati sigurnosne standarde i postupke odgovora na opasne proizvode diljem Europske unije. Uskla\u0111enost s ovim zakonom klju\u010dna je za pristup tr\u017ei\u0161tu i za\u0161titu potro\u0161a\u010da.  <\/p>\n<h2>FAQ<\/h2>\n<h3>Pitanje: Moram li predati PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Da, ako va\u0161 medicinski ure\u0111aj sadr\u017ei opasne kemikalije, potreban je PCN. To osigurava da hitne slu\u017ebe mogu pristupiti vitalnim informacijama o kemijskim tvarima u va\u0161em proizvodu, pobolj\u0161avaju\u0107i sigurnost u slu\u010daju izlo\u017eenosti. <\/p>\n<h3>Pitanje: Koje informacije moram uklju\u010diti u PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: PCN za va\u0161 medicinski ure\u0111aj mora sadr\u017eavati podatke o opasnim tvarima koje sadr\u017ei, njihovu CLP klasifikaciju, mjere hitnog odgovora i UFI. Klju\u010dno je osigurati da su informacije to\u010dne i u skladu s propisima EU-a. <\/p>\n<h3>Pitanje: \u0160to se doga\u0111a ako ne predam PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Nepodno\u0161enje PCN-a mo\u017ee rezultirati nov\u010danim kaznama, kaznama i uklanjanjem va\u0161eg proizvoda s tr\u017ei\u0161ta. Osim toga, djelatnicima hitne pomo\u0107i mogu nedostajati klju\u010dne informacije za upravljanje incidentima izlo\u017eenosti, \u0161to mo\u017ee dovesti do ozbiljnih zdravstvenih posljedica. <\/p>\n<h3>Pitanje: Kako mogu predati PCN za svoj medicinski ure\u0111aj?<\/h3>\n<p>Odgovor: Za podno\u0161enje PCN-a morat \u0107ete prikupiti potrebne sigurnosne podatke, uklju\u010duju\u0107i UFI, oznaku proizvoda sukladno CLP-u i klasifikaciju opasnosti. Na\u0161a tvrtka nudi usluge koje \u0107e vam pomo\u0107i da pripremite obavijest o svom proizvodu i podnesete je Centru za otrovanja na uskla\u0111enost. <\/p>\n<h3>Pitanje: Koliko je vremena potrebno za podno\u0161enje UFI i PCN obavijesti?<\/h3>\n<p>Treba nam nekoliko dana rada. \u010cim u\u010ditate dokumentaciju, odmah \u0107emo zapo\u010deti. <\/p>\n<h3>Pitanje: Jesam li ja vlasnik PCN obavijesti?<\/h3>\n<p>Da, vi ste vlasnik PCN obavijesti. Vi zadr\u017eavate puno vlasni\u0161tvo nad podacima koje ste dali.  PCN obavijest bit \u0107e dostupna na va\u0161em ECHA ra\u010dunu.<\/p>\n<h3>Pitanje: Je li ova usluga za jedan ili vi\u0161e proizvoda?<\/h3>\n<p>Usluga se odnosi na jedan proizvod.<\/p>\n<h3>Pitanje: Za\u0161to moram platiti za izradu UFI-ja?<\/h3>\n<p>Usluga koju nudimo nije samo pru\u017eanje UFI-ja. UFI je komponenta unutar mnogo opse\u017enijeg procesa.  Osnovna usluga koju pru\u017eamo je priprema i podno\u0161enje Va\u0161e Obavijesti Centra za otrovanje (PCN) nacionalnim imenovanim tijelima putem ECHA portala, \u0161to je obavezan uvjet prema EU CLP Uredbi za stavljanje opasnih smjesa na tr\u017ei\u0161te. Generiranje UFI-ja je najjednostavniji dio. Me\u0111utim, PCN izvje\u0161\u0107e je slo\u017eeno. Zahtijeva detaljan pregled sastojaka\u2014kemijske klasifikacije\u2014formatiran precizno za podno\u0161enje Centru za otrovanja putem ECHA-e.   <\/p>\n<h3>Pitanje: Moja tvrtka nema sjedi\u0161te u EU, kako mogu predati PCN?<\/h3>\n<p>Pru\u017eamo rje\u0161enje za tvrtke koje nemaju sjedi\u0161te u EU. Vi\u0161e informacija mo\u017eete prona\u0107i na stranici <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/izvan-eu\/pcn-ufi-za-tvrtke-izvan-eu\/\" target=\"_blank\" rel=\"noopener\">PCN &amp; UFI za tvrtke izvan EU<\/a> . <\/p>\n<h3>Pitanje: Mo\u017eete li dostaviti sigurnosno-tehni\u010dke listove u potpunosti u skladu s Uredbom EU (REACH &amp; CLP)?<\/h3>\n<p>Da, mo\u017eemo <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/sigurnosno-tehnicki-list\/usluga-izrade-sigurnosno-tehnickog-lista-msds-sds\/\" target=\"_blank\"><strong>izraditi sigurnosno-tehni\u010dke listove (SDS)<\/strong><\/a> \u2014 poznate i kao <strong>sigurnosno-tehni\u010dki listovi (MSDS)<\/strong> \u2014 prilago\u0111ene va\u0161em proizvodu i u skladu s najnovijim propisima EU-a. Bez obzira proizvodite li kemijske smjese, uvozite proizvode u EU ili distribuirate pod privatnom robnom markom, uskla\u0111en SDS je zakonski obavezan i neophodan za sigurnu upotrebu u cijelom opskrbnom lancu. Vi\u0161e \u0107ete prona\u0107i na stranici <a href=\"https:\/\/www.ufi.eu\/hr\/pcn\/sigurnosno-tehnicki-list\/usluga-izrade-sigurnosno-tehnickog-lista-msds-sds\/\" target=\"_blank\">usluge izrade sigurnosno-tehni\u010dkog lista (MSDS\/SDS)<\/a> .  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kako funkcionira usluga kreiranja UFI-ja i PCN obavijesti? Nakon kupnje ove usluge dobit \u0107ete pristup sigurnom portalu. Ovaj portal sadr\u017ei pregled svih koraka. Ispunite podatke o proizvodu i mi \u0107emo se baciti na posao. Obavijest i UFI Centra za otrove Osigurat \u0107emo: Jedinstveni identifikator formule (UFI) va\u0161eg proizvoda Izvje\u0161\u0107e Centra za otrovanje (PCN). Registracija va\u0161eg [&hellip;]<\/p>\n","protected":false},"featured_media":21530,"template":"","meta":[],"product_brand":[],"product_cat":[1061],"product_tag":[],"class_list":["post-21529","product","type-product","status-publish","has-post-thumbnail","product_cat-medicinski-uredaji","first","instock","virtual","taxable","purchasable","product-type-bundle"],"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":"","bundle_virtual":false,"bundle_layout":"default","bundle_add_to_cart_form_location":"default","bundle_editable_in_cart":false,"bundle_sold_individually_context":"product","bundle_item_grouping":"parent","bundle_min_size":"","bundle_max_size":"","bundle_price":{"price":{"min":{"incl_tax":"121","excl_tax":"100"},"max":{"incl_tax":"","excl_tax":""}},"regular_price":{"min":{"incl_tax":"121","excl_tax":"100"},"max":{"incl_tax":"","excl_tax":""}}},"bundled_items":[{"bundled_item_id":10260,"product_id":12524,"menu_order":0,"quantity_min":1,"quantity_max":1,"quantity_default":1,"priced_individually":true,"shipped_individually":false,"override_title":false,"title":null,"override_description":false,"description":null,"optional":false,"hide_thumbnail":false,"discount":"","override_variations":false,"allowed_variations":[""],"override_default_variation_attributes":false,"default_variation_attributes":[],"single_product_visibility":"visible","cart_visibility":"visible","order_visibility":"visible","single_product_price_visibility":"visible","cart_price_visibility":"visible","order_price_visibility":"visible","stock_status":"in_stock"},{"bundled_item_id":10261,"product_id":12514,"menu_order":1,"quantity_min":1,"quantity_max":"","quantity_default":1,"priced_individually":true,"shipped_individually":false,"override_title":false,"title":null,"override_description":false,"description":null,"optional":false,"hide_thumbnail":false,"discount":"","override_variations":false,"allowed_variations":[""],"override_default_variation_attributes":false,"default_variation_attributes":[],"single_product_visibility":"visible","cart_visibility":"visible","order_visibility":"visible","single_product_price_visibility":"visible","cart_price_visibility":"visible","order_price_visibility":"visible","stock_status":"in_stock"}],"bundle_sell_ids":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.1 (Yoast SEO v25.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PCN &amp; UFI za druge medicinske ure\u0111aje - UFI<\/title>\n<meta name=\"description\" content=\"Nabavite PCN i UFI za druge medicinske ure\u0111aje. 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