{"id":4880,"date":"2025-10-16T09:57:03","date_gmt":"2025-10-16T08:57:03","guid":{"rendered":"https:\/\/www.fytofontana.com\/?page_id=4880"},"modified":"2025-10-16T10:58:32","modified_gmt":"2025-10-16T09:58:32","slug":"mdr","status":"publish","type":"page","link":"https:\/\/www.fytofontana.com\/cs\/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 zdravotnick\u00e9 prost\u0159edky spl\u0148uj\u00ed po\u017eadavky MDR 2017\/745<\/h2>\n\t\t\t<p><!-- wp:paragraph --><\/p>\n<p>Spole\u010dnost <strong>Herb-Pharma AG <\/strong>\u00fasp\u011b\u0161n\u011b pro\u0161la procesem certifikace podle <strong>Na\u0159\u00edzen\u00ed Evropsk\u00e9ho parlamentu a Rady (EU) 2017\/745 o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR).<\/strong><\/p>\n<p>Na\u0161e produkty tak spl\u0148uj\u00ed nejp\u0159\u00edsn\u011bj\u0161\u00ed evropsk\u00e9 po\u017eadavky na bezpe\u010dnost, \u00fa\u010dinnost a kvalitu zdravotnick\u00fdch prost\u0159edk\u016f.<\/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-e1760477430866.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 certifikace<\/h2>\n\t\t\t<p>Na z\u00e1klad\u011b posouzen\u00ed notifikovan\u00e9 osoby <strong>3EC International a. s., NB 2265<\/strong> byly podle MDR \u00fasp\u011b\u0161n\u011b certifikov\u00e1ny tyto zdravotnick\u00e9 prost\u0159edky:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.fytofontana.com\/cs\/products\/virostop-cz\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana VIROSTOP<\/strong><\/a> \u2013 \u00fastn\u00ed sprej, nosn\u00ed sprej a pastilky (ZP t\u0159\u00eddy IIa)<\/li>\n<li><a href=\"https:\/\/www.fytofontana.com\/cs\/products\/gyntima-cz\/\" target=\"_blank\" rel=\"noopener\"><strong>fytofontana GYNTIMA<\/strong><\/a> \u2013 vagin\u00e1ln\u00ed \u010d\u00edpky (ZP t\u0159\u00eddy 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 syst\u00e9mu \u0159\u00edzen\u00ed kvality EU \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 procesu MDR certifikace<\/h2>\n\t\t\t<p>Zdravotnick\u00e9 prost\u0159edky zna\u010dek <a href=\"https:\/\/www.fytofontana.com\/cs\/products\/aurecon-cz\/\" target=\"_blank\" rel=\"noopener\"><strong>AURECON<\/strong> (u\u0161n\u00ed kapky a spreje)<\/a> a <a href=\"https:\/\/www.fytofontana.com\/cs\/products\/hemorrelax-cz\/\" target=\"_blank\" rel=\"noopener\"><strong>HEMORRELAX<\/strong> (rekt\u00e1ln\u00ed kr\u00e9m a \u010d\u00edpky)<\/a> jsou ji\u017e za\u0159azeny do procesu MDR certifikace.<\/p>\n<p>Notifikovan\u00e1 osoba <strong>3EC International a. s.<\/strong> potvrdila p\u0159ijet\u00ed form\u00e1ln\u00ed \u017e\u00e1dosti, podeps\u00e1n\u00ed p\u00edsemn\u00e9 dohody a vykon\u00e1v\u00e1 vhodn\u00fd dohled podle <strong>Na\u0159\u00edzen\u00ed (EU) 2023\/607<\/strong>, kter\u00e9 upravuje p\u0159echodn\u00e1 ustanoven\u00ed pro zdravotnick\u00e9 prost\u0159edky do syst\u00e9mu MDR.<\/p>\n<p>Tyto produkty jsou proto uv\u00e1d\u011bny na trh v pln\u00e9m souladu s platnou evropskou legislativou a jsou \u0159\u00e1dn\u011b monitorov\u00e1ny podle dohod uzav\u0159en\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 podle EN ISO 13485:2016<\/h2>\n\t\t\t<p><strong>Herb-Pharma AG <\/strong>vlastn\u00ed tak\u00e9<strong> certifik\u00e1t syst\u00e9mu managementu kvality podle normy EN ISO 13485:2016, vydan\u00fd v souladu s Na\u0159\u00edzen\u00edm Evropsk\u00e9ho parlamentu a Rady (EU) 2017\/745 o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR).<\/strong><\/p>\n<p>Tento certifik\u00e1t potvrzuje, \u017ee procesy n\u00e1vrhu, v\u00fdvoje a v\u00fdroby zdravotnick\u00fdch prost\u0159edk\u016f spl\u0148uj\u00ed mezin\u00e1rodn\u011b uzn\u00e1van\u00e9 standardy kvality a jsou pln\u011b v souladu s po\u017eadavky 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\">Pro\u010d je to d\u016fle\u017eit\u00e9<\/h2>\n\t\t\t<p>D\u00edky t\u011bmto certifikac\u00edm mohou b\u00fdt na\u0161e <strong>zdravotnick\u00e9 prost\u0159edky i nad\u00e1le leg\u00e1ln\u011b uv\u00e1d\u011bny, distribuov\u00e1ny a prod\u00e1v\u00e1ny na trhu<\/strong> v zem\u00edch Evropsk\u00e9 unie.<\/p>\n<p>Pro na\u0161e partnery a z\u00e1kazn\u00edky je to z\u00e1ruka, \u017ee ka\u017ed\u00fd produkt <strong>Herb-Pharma AG<\/strong> vznik\u00e1 v souladu s evropskou legislativou, <strong>pod p\u0159\u00edsn\u00fdm syst\u00e9mem \u0159\u00edzen\u00ed a kontroly kvality<\/strong> a nez\u00e1visl\u00fdm posouzen\u00edm notifikovan\u00e9 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, 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