{"id":4654,"date":"2025-10-15T19:07:07","date_gmt":"2025-10-15T18:07:07","guid":{"rendered":"https:\/\/www.fytofontana.com\/?page_id=4654"},"modified":"2025-10-16T10:58:08","modified_gmt":"2025-10-16T09:58:08","slug":"mdr","status":"publish","type":"page","link":"https:\/\/www.fytofontana.com\/sk\/mdr\/","title":{"rendered":"MDR"},"content":{"rendered":"\n<h2><\/h2>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container\"><section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Na\u0161e zdravotn\u00edcke pom\u00f4cky sp\u013a\u0148aj\u00fa po\u017eiadavky MDR 2017\/745<\/h2>\n\t\t\t<p><!-- wp:paragraph --><\/p>\n<p>Spolo\u010dnos\u0165 <strong>Herb-Pharma AG<\/strong> \u00faspe\u0161ne pre\u0161la procesom certifik\u00e1cie pod\u013ea <strong>nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2017\/745 o zdravotn\u00edckych pom\u00f4ckach (MDR)<\/strong>.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>Na\u0161e produkty tak sp\u013a\u0148aj\u00fa najpr\u00edsnej\u0161ie eur\u00f3pske po\u017eiadavky na bezpe\u010dnos\u0165, \u00fa\u010dinnos\u0165 a kvalitu zdravotn\u00edckych pom\u00f4cok.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/199e47657d44c-1-e1760552166282.png\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n<\/div><\/div>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Produktov\u00e9 certifik\u00e1cie<\/h2>\n\t\t\t<p>Na z\u00e1klade pos\u00fadenia notifikovanou osobou <strong>3EC International a. s., NB 2265<\/strong> boli pod\u013ea MDR \u00faspe\u0161ne certifikovan\u00e9 tieto zdravotn\u00edcke pom\u00f4cky:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.fytofontana.com\/sk\/products\/virostop-sk\/\"><strong>fytofontana VIROSTOP<\/strong><\/a> \u2013 \u00fastny sprej, nosov\u00fd sprej a pastilky (ZP triedy IIa).<\/li>\n<li><a href=\"https:\/\/www.fytofontana.com\/sk\/products\/gyntima-sk\/\"><strong>fytofontana GYNTIMA<\/strong><\/a> \u2013 vagin\u00e1lne \u010dap\u00edky (ZP triedy IIb).<\/li>\n<\/ul>\n<p style=\"margin-top: 15px;\">\ud83d\udcc4 <a style=\"color: #3e5435; font-weight: bold; text-decoration: none;\" href=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/F17A1_NR_SK_Certifikat-EU-systemu-riadenia-kvality_VIROSTOP-HerbPharma.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nVIROSTOP \u2013 Certifik\u00e1t E\u00da syst\u00e9mu riadenia kvality \u010d. 2024-MDR\/QS-023\/A<\/a><\/p>\n<p>\ud83d\udcc4 <a style=\"color: #3e5435; font-weight: bold; text-decoration: none;\" href=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/F17A1_NR_SK_Certifikat-EU-systemu-riadenia-kvality_GYNTIMA_HerbPharma.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nGYNTIMA \u2013 Certifik\u00e1t E\u00da syst\u00e9mu riadenia kvality \u010d. 2025-MDR\/QS-003<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/Dizajn-bez-nazvu-1.jpg\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">V procese MDR certifik\u00e1cie<\/h2>\n\t\t\t<p>Zdravotn\u00edcke pom\u00f4cky zna\u010diek <a href=\"https:\/\/www.fytofontana.com\/sk\/products\/aurecon-sk\/\"><strong>AURECON<\/strong> (u\u0161n\u00e9 kvapky a spreje)<\/a> a <a href=\"https:\/\/www.fytofontana.com\/sk\/products\/hemorrelax-sk\/\"><strong>HEMORRELAX<\/strong> (rekt\u00e1lny kr\u00e9m a \u010dap\u00edky)<\/a> s\u00fa u\u017e zaraden\u00e9 do procesu MDR certifik\u00e1cie.<\/p>\n<p>Notifikovan\u00e1 osoba <strong>3EC International a. s.<\/strong> potvrdila prijatie form\u00e1lnej \u017eiadosti, podp\u00edsanie p\u00edsomnej dohody a vykon\u00e1va vhodn\u00fd doh\u013ead pod\u013ea <strong>Nariadenia (E\u00da) 2023\/607<\/strong>, ktor\u00e9 upravuje prechodn\u00e9 ustanovenia pre zdravotn\u00edcke pom\u00f4cky do syst\u00e9mu MDR.<\/p>\n<p>Tieto produkty s\u00fa preto uveden\u00e9 na trhu v plnom s\u00falade s platnou eur\u00f3pskou legislat\u00edvou a s\u00fa riadne monitorovan\u00e9 pod\u013ea doh\u00f4d uzavret\u00fdch s notifikovanou osobou.<\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/Dizajn-bez-nazvu-1-1.jpg\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Syst\u00e9m kvality pod\u013ea EN ISO 13485:2016<\/h2>\n\t\t\t<p><strong>Herb-Pharma AG<\/strong> z\u00e1rove\u0148 vlastn\u00ed aj <strong>certifik\u00e1t syst\u00e9mu mana\u017e\u00e9rstva kvality pod\u013ea normy EN ISO 13485:2016<\/strong>, <strong>vydan\u00fd v s\u00falade s Nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2017\/745 o zdravotn\u00edckych pom\u00f4ckach (MDR)<\/strong>.<\/p>\n<p>Tento certifik\u00e1t potvrdzuje, \u017ee proces n\u00e1vrhu, v\u00fdvoja a v\u00fdroby zdravotn\u00edckych pom\u00f4cok sp\u013a\u0148a medzin\u00e1rodne uzn\u00e1van\u00e9 \u0161tandardy kvality a je plne zos\u00faladen\u00fd s po\u017eiadavkami MDR.<\/p>\n<p style=\"margin-top: 15px;\">\ud83d\udcc4 <a style=\"color: #3e5435; font-weight: bold; text-decoration: none;\" href=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/M-0549-23_Herb-Pharma_SK.pdf\" target=\"_blank\" rel=\"noopener\"><br \/>\nCertifik\u00e1t EN ISO 13485:2016 <\/a><\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/Snimka-obrazovky-2025-04-03-112927.png\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n\n\n<section class=\"container py-20 lg:py-40\">\n\t<div class=\"flex flex-wrap -mx-2\">\n\t\t\t\t<div class=\"w-full lg:w-5\/12 px-2\">\n\t\t\t<h2 class=\"mb-6 text-4xl font-extrabold leading-tight\">Pre\u010do je to d\u00f4le\u017eit\u00e9<\/h2>\n\t\t\t<p>V\u010faka t\u00fdmto certifik\u00e1ci\u00e1m m\u00f4\u017eu by\u0165 na\u0161e <strong>zdravotn\u00edcke pom\u00f4cky aj na\u010falej leg\u00e1lne uv\u00e1dzan\u00e9, distribuovan\u00e9 a pred\u00e1van\u00e9 na trhu<\/strong> v krajin\u00e1ch Eur\u00f3pskej \u00fanie.<\/p>\n<p>Pre na\u0161ich partnerov a z\u00e1kazn\u00edkov je to z\u00e1ruka, \u017ee ka\u017ed\u00fd produkt <strong>Herb-Pharma AG<\/strong> vznik\u00e1 v s\u00falade s eur\u00f3pskou legislat\u00edvou, <strong>pod pr\u00edsnym syst\u00e9mom riadenia a kontroly kvality<\/strong> a nez\u00e1visl\u00fdm posudzovan\u00edm notifikovanej osoby.<\/p>\n\t\t<\/div>\n\t\t\t\t<div class=\"w-full lg:w-7\/12 px-2\">\n\t\t\t<img src=\"https:\/\/www.fytofontana.com\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-15.-10.-2025-21_30_32_jpg.jpg\" alt=\"\" class=\"mb-6 lg:mb-0\">\n\t\t<\/div>\n\t\t\t<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"yoast_head":"<title>MDR - Fytofontana<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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