{"id":11432,"date":"2021-11-04T10:57:39","date_gmt":"2021-11-04T10:57:39","guid":{"rendered":"https:\/\/balancebelt.brthrs.io\/?p=11432"},"modified":"2025-09-01T16:36:56","modified_gmt":"2025-09-01T14:36:56","slug":"balancebelt-officially-registered-as-class-1-medical-device","status":"publish","type":"post","link":"https:\/\/balancebelt.net\/nl\/balancebelt-officially-registered-as-class-1-medical-device\/","title":{"rendered":"BalanceBelt officieel geregistreerd als klasse 1 medisch hulpmiddel"},"content":{"rendered":"<div id=\"fws_6a3273d056bbe\"  data-column-margin=\"default\" data-midnight=\"dark\"  class=\"wpb_row vc_row-fluid vc_row\"  style=\"padding-top: 0px; padding-bottom: 0px; \"><div class=\"row-bg-wrap\" data-bg-animation=\"none\" data-bg-animation-delay=\"\" data-bg-overlay=\"false\"><div class=\"inner-wrap row-bg-layer\" ><div class=\"row-bg viewport-desktop\"  style=\"\"><\/div><\/div><\/div><div class=\"row_col_wrap_12 col span_12 dark left\">\n\t<div  class=\"vc_col-sm-12 wpb_column column_container vc_column_container col no-extra-padding inherit_tablet inherit_phone\"  data-padding-pos=\"all\" data-has-bg-color=\"false\" data-bg-color=\"\" data-bg-opacity=\"1\" data-animation=\"\" data-delay=\"0\" >\n\t\t<div class=\"vc_column-inner\" >\n\t\t\t<div class=\"wpb_wrapper\">\n\t\t\t\t\n<div class=\"wpb_text_column wpb_content_element\" >\n\t<div class=\"wpb_wrapper\">\n\t\t<p><em><a href=\"https:\/\/elitacwearables.com\/?utm_source=press&amp;utm_medium=pr&amp;utm_campaign=Medical_Class_1_press_release\">Elitac-wearables<\/a> heeft de BalanceBelt, een unieke, draagbare behandeling voor pati\u00ebnten met ernstige evenwichtsstoornissen, officieel geregistreerd als een Klasse 1 medisch hulpmiddel bij de Europese Unie Medical Device Regulation (MDR). Het voldoen aan de MDR-normen geeft aan dat de BalanceBelt is ontwikkeld volgens de EU MDR-pati\u00ebntveiligheidsnormen en normen voor productkwaliteit en betrouwbaarheid.<\/em><\/p>\n<p><strong>15 november 2021, Utrecht - Nederland<\/strong> De BalanceBelt is bedoeld voor mensen die lijden aan Bilaterale Vestibulaire Hypofunctie of Verlies (BVH\/BVL). Deze aandoeningen, waarbij de evenwichtsorganen in beide oren ofwel aangetast zijn of volledig niet functioneren, hadden voorheen geen duurzame of niet-invasieve behandelingsmogelijkheden.<\/p>\n<h3>Internationale distributie vergemakkelijken<\/h3>\n<p>Erland Fuglsbjerg, Managing Director van Elitac BalanceBelt B.V., lichtte de beslissing toe: \"Sinds we de BalanceBelt hebben gelanceerd, hebben we een groeiende internationale belangstelling gehad van pati\u00ebnten, artsen en distributeurs. Echter, in regio's die de CE-markering accepteren, is de Class 1 Medical Device classificatie vereist voor artsen om de oplossing voor te schrijven aan pati\u00ebnten. Deze registratie stelt ons in staat om alle markten te betreden die Klasse 1 Medische Hulpmiddelen met een CE-markering accepteren en vermindert veel van de kosten die gepaard gaan met het importeren van een medisch hulpmiddel. Op deze manier kunnen we de band beschikbaar maken voor veel meer mensen die lijden aan BVH\/BVL.\"<\/p>\n<h3>Meer aandacht voor de ontwikkeling van medische wearables<\/h3>\n<p>De BalanceBelt is ontwikkeld door Elitac Wearables in samenwerking met gerenommeerd vestibulair expert <a href=\"https:\/\/balancebelt.net\/nl\/about-prof-dr-kingma\/\">Prof. Dr. Kingma<\/a> en het Maastricht UMC+ (NL). Het is een van de verschillende medische wearables die zijn ontwikkeld door het in Nederland gevestigde bedrijf dat wearables ontwikkelt. Het bedrijf is gespecialiseerd in de integratie van textiel en elektronica, met een bijzondere focus op haptische feedback en sensoren.<\/p>\n<p>De MDR-registratie van de BalanceBelt illustreert de toegenomen focus van Elitac Wearables op de ontwikkeling van meer draagbare medische apparaten in de toekomst. Medeoprichter en CEO Merijn Klarenbeek legt uit: \"We zien een onge\u00ebvenaard potentieel voor draagbare technologie om het leven van mensen met medische aandoeningen en de standaard van medische zorg te verbeteren.\"<\/p>\n<p>\"Daarom ondernemen we stappen om ISO 13485 certificering voor ons bedrijf te behalen. Het ontwikkelen van wearables volgens deze internationale norm zal ons helpen om consistent medische wearables te blijven ontwerpen, ontwikkelen en produceren die veilig zijn in gebruik. We herzien momenteel al onze processen en verwachten in de loop van 2022 de ISO 13485-certificering voor ons bedrijf te behalen.\"<\/p>\n<p>\"De registratie van de BalanceBelt als Klasse 1 Medisch Hulpmiddel is een belangrijke stap om zoveel mogelijk BVH\/BVL-pati\u00ebnten te laten profiteren van deze unieke behandeling.\"<\/p>\n\t<\/div>\n<\/div>\n\n\n\n\n\t\t\t<\/div> \n\t\t<\/div>\n\t<\/div> \n<\/div><\/div>","protected":false},"excerpt":{"rendered":"Elitac Wearables heeft de BalanceBelt, een unieke, draagbare behandeling voor pati\u00ebnten met ernstige evenwichtsstoornissen, officieel geregistreerd als een Klasse 1 Medisch...","protected":false},"author":2,"featured_media":11646,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[171],"tags":[],"class_list":{"0":"post-11432","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-news"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v26.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BalanceBelt officially registered as Class 1 Medical Device &#8212; BalanceBelt<\/title>\n<meta name=\"description\" content=\"Elitac Wearables has registered the BalanceBelt, a unique, wearable treatment for patients with severe balance disorders, officially as a Class 1 Medical Device with the European Union Medical Device Regulation (MDR).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/balancebelt.net\/nl\/balancebelt-officially-registered-as-class-1-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BalanceBelt officially registered as Class 1 Medical Device\" \/>\n<meta property=\"og:description\" content=\"Elitac Wearables has registered the BalanceBelt, a unique, wearable treatment for patients with severe balance disorders, officially as a Class 1 Medical Device with the European Union Medical Device Regulation (MDR).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/balancebelt.net\/nl\/balancebelt-officially-registered-as-class-1-medical-device\/\" \/>\n<meta property=\"og:site_name\" content=\"BalanceBelt\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/TheBalanceBelt\" \/>\n<meta property=\"article:published_time\" content=\"2021-11-04T10:57:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-01T14:36:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/balancebelt.net\/wp-content\/uploads\/2021\/10\/The-BalanceBelt-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2000\" \/>\n\t<meta property=\"og:image:height\" content=\"2000\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Dani van Weert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"BalanceBelt officially registered as Class 1 Medical Device\" \/>\n<meta name=\"twitter:description\" content=\"Elitac Wearables has registered the BalanceBelt, a unique, wearable treatment for patients with severe balance disorders, officially as a Class 1 Medical Device with the European Union Medical Device Regulation (MDR).\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/balancebelt.net\/wp-content\/uploads\/2021\/10\/The-BalanceBelt-1.jpg\" \/>\n<meta name=\"twitter:creator\" content=\"@BalanceBelt_\" \/>\n<meta name=\"twitter:site\" content=\"@BalanceBelt_\" \/>\n<meta name=\"twitter:label1\" content=\"Geschreven door\" \/>\n\t<meta name=\"twitter:data1\" content=\"Dani van Weert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Geschatte leestijd\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/balancebelt.net\/balancebelt-officially-registered-as-class-1-medical-device\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/balancebelt.net\/balancebelt-officially-registered-as-class-1-medical-device\/\"},\"author\":{\"name\":\"Dani van Weert\",\"@id\":\"https:\/\/balancebelt.net\/nl\/#\/schema\/person\/2e9c00e4f6569c56ddec4d0e879b9bc9\"},\"headline\":\"BalanceBelt officially registered as Class 1 Medical Device\",\"datePublished\":\"2021-11-04T10:57:39+00:00\",\"dateModified\":\"2025-09-01T14:36:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/balancebelt.net\/balancebelt-officially-registered-as-class-1-medical-device\/\"},\"wordCount\":543,\"publisher\":{\"@id\":\"https:\/\/balancebelt.net\/nl\/#organization\"},\"image\":{\"@id\":\"https:\/\/balancebelt.net\/balancebelt-officially-registered-as-class-1-medical-device\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/balancebelt.net\/wp-content\/uploads\/2021\/11\/BalanceBelt-with-travel-case-featured-image.jpg\",\"articleSection\":[\"News\"],\"inLanguage\":\"nl-NL\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/balancebelt.net\/balancebelt-officially-registered-as-class-1-medical-device\/\",\"url\":\"https:\/\/balancebelt.net\/balancebelt-officially-registered-as-class-1-medical-device\/\",\"name\":\"BalanceBelt officially registered as Class 1 Medical Device &#8212; 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