{"id":45955,"date":"2026-07-30T15:43:19","date_gmt":"2026-07-30T13:43:19","guid":{"rendered":"https:\/\/stimcareonline.com\/?p=45955"},"modified":"2026-07-30T15:43:23","modified_gmt":"2026-07-30T13:43:23","slug":"dm-de-classe-i-pourquoi-les-patchs-stimcare-en-sont","status":"publish","type":"post","link":"https:\/\/stimcareonline.com\/it\/dm-de-classe-i-pourquoi-les-patchs-stimcare-en-sont\/","title":{"rendered":"DM di classe I: perch\u00e9 i cerotti STIMCARE ne fanno parte"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"45955\" class=\"elementor elementor-45955\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c346c43 e-flex e-con-boxed e-con e-parent\" data-id=\"c346c43\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bb89164 elementor-widget elementor-widget-html\" data-id=\"bb89164\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<!-- ============================================================\r\n     Article blog STIMCARE \u2014 \"Dispositif m\u00e9dical de classe I\"\r\n     \u00c0 coller dans un module Code \/ Texte de Divi. Styles inline.\r\n     ============================================================ -->\r\n<div style=\"max-width:820px;margin:0 auto;font-family:'Helvetica Neue',Arial,sans-serif;color:#2b2f36;line-height:1.75;font-size:17px;\">\r\n\r\n  <p style=\"margin:0 0 8px;font-size:14px;letter-spacing:.08em;text-transform:uppercase;color:#f2704a;font-weight:600;\">Capire i nostri cerotti<\/p>\r\n\r\n  <h1 style=\"font-size:33px;line-height:1.25;color:#132a3a;font-weight:700;margin:0 0 20px;\">Dispositivo medico di classe I: perch\u00e9 i cerotti STIMCARE rientrano in questa categoria e quali vantaggi offrono<\/h1>\r\n\r\n  <p style=\"margin:0 0 18px;font-size:19px;color:#4a515c;\">Sul mercato dei cerotti si trova di tutto: accessori per il benessere, gadget privi di qualsiasi fondamento scientifico e alcuni veri e propri dispositivi medici. I cerotti STIMCARE rientrano in quest\u2019ultima categoria. Dietro questo termine un po\u2019 tecnico si nascondono standard elevati e, soprattutto, garanzie concrete per voi. Ve lo spieghiamo in modo semplice.<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">Che cos'\u00e8 esattamente un dispositivo medico?<\/h2>\r\n\r\n  <p style=\"margin:0 0 18px;\">Un dispositivo medico (DM) non \u00e8 un medicinale. \u00c8 un prodotto a cui il produttore attribuisce una <strong>finalit\u00e0 medica<\/strong>, ad esempio contribuire ad alleviare il dolore, ma che agisce attraverso un meccanismo fisico, senza alcuna azione farmacologica nell\u2019organismo. \u00c8 questo che distingue un cerotto STIMCARE da un semplice accessorio di comfort: ha una destinazione d\u2019uso precisa, ovvero l\u2019alleviamento del dolore, ed \u00e8 regolamentato dal <strong>Regolamento europeo sui dispositivi medici (MDR 2017\/745)<\/strong>.<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">E la \u00abclasse I\u00bb, in tutto questo?<\/h2>\r\n\r\n  <p style=\"margin:0 0 18px;\">I dispositivi medici sono classificati in base al loro livello di rischio, a partire dal <strong>classe I<\/strong> (il pi\u00f9 basso) alla <strong>classe III<\/strong> (il pi\u00f9 elevato, come nel caso di un impianto cardiaco). Questa classificazione dipende in particolare dal carattere invasivo del prodotto, dalla durata del contatto con il corpo e dalla presenza o meno di una fonte di energia.<\/p>\r\n\r\n  <p style=\"margin:0 0 18px;\">Un prodotto che si installa <strong>sulla pelle integra<\/strong>, senza alcuna iniezione e senza fonte di energia esterna, rientra nella classe I. \u00c8 esattamente il caso dei cerotti STIMCARE (regola 1 dell'allegato VIII del MDR).<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">Perch\u00e9 i cerotti STIMCARE sono dispositivi medici di classe I<\/h2>\r\n\r\n  <p style=\"margin:0 0 12px;\">Tre semplici motivi:<\/p>\r\n  <ul style=\"margin:0 0 18px;padding-left:22px;\">\r\n    <li style=\"margin-bottom:12px;\"><strong>Una destinazione turistica dedicata alla medicina.<\/strong> Ogni cerotto \u00e8 studiato per aiutare ad alleviare un tipo specifico di fastidio: mestruazioni dolorose, dolori articolari, disturbi digestivi o fastidi legati all'attivit\u00e0 sportiva, a seconda del modello.<\/li>\r\n    <li style=\"margin-bottom:12px;\"><strong>Un modo di agire fisico e passivo.<\/strong> La tecnologia eNOsyntex\u2122 riflette verso i tessuti i raggi infrarossi che il corpo emette naturalmente, senza farmaci, senza principi attivi e senza fonti di energia.<\/li>\r\n    <li style=\"margin-bottom:0;\"><strong>Un'applicazione non invasiva.<\/strong> Il cerotto va applicato sulla pelle integra: nulla penetra nell'organismo.<\/li>\r\n  <\/ul>\r\n  <p style=\"margin:0 0 18px;\">Queste tre caratteristiche collocano naturalmente i cerotti STIMCARE nella classe I.<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">Cosa vi offre concretamente<\/h2>\r\n\r\n  <p style=\"margin:0 0 16px;\">Questo \u00e8 il punto pi\u00f9 importante. Essere un dispositivo medico di classe I non \u00e8 solo un\u2019etichetta di marketing: si tratta di una serie di obblighi che il produttore deve rispettare e, di conseguenza, di altrettante garanzie per voi.<\/p>\r\n\r\n  <div style=\"background:#f6f8fa;border-radius:14px;padding:22px 26px;margin:0 0 20px;\">\r\n    <ul style=\"margin:0;padding-left:20px;\">\r\n      <li style=\"margin-bottom:12px;\"><strong>Una sicurezza comprovata<\/strong> : i materiali a contatto con la pelle vengono sottoposti a test di biocompatibilit\u00e0 e i rischi vengono analizzati e controllati (norme ISO 14971 e ISO 10993).<\/li>\r\n      <li style=\"margin-bottom:12px;\"><strong>Una valutazione clinica<\/strong> : le prestazioni e il rapporto rischio\/beneficio vengono valutati sulla base di dati clinici (linee guida MEDDEV 2.7\/1).<\/li>\r\n      <li style=\"margin-bottom:12px;\"><strong>Istruzioni per l'uso e modalit\u00e0 d'uso regolamentate<\/strong> : l'indicazione terapeutica, le precauzioni d'uso e le controindicazioni sono chiaramente indicate.<\/li>\r\n      <li style=\"margin-bottom:12px;\"><strong>La tracciabilit\u00e0<\/strong> : ogni prodotto possiede un identificativo unico (UDI) ed \u00e8 registrato nella banca dati europea EUDAMED.<\/li>\r\n      <li style=\"margin-bottom:12px;\"><strong>Un monitoraggio continuo<\/strong> : il produttore monitora i propri prodotti dopo la loro immissione sul mercato e segnala eventuali incidenti (vigilanza).<\/li>\r\n      <li style=\"margin-bottom:12px;\"><strong>La marcatura CE<\/strong> : STIMCARE dichiara la conformit\u00e0 dei propri cerotti alla normativa europea, sotto la propria piena responsabilit\u00e0 e sotto l'eventuale controllo delle autorit\u00e0 (in Francia, l'ANSM).<\/li>\r\n      <li style=\"margin-bottom:0;\"><strong>Prodotto in Francia<\/strong>, nell'ambito del sistema di gestione della qualit\u00e0 (ISO 13485).<\/li>\r\n    <\/ul>\r\n  <\/div>\r\n\r\n  <p style=\"margin:0 0 18px;\">Al contrario, un semplice accessorio per il benessere non \u00e8 soggetto a nessuno di questi obblighi. \u00c8 proprio questa la differenza tra un cerotto realmente regolamentato e un gadget che si limita a una confezione accattivante.<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">Cosa non significa<\/h2>\r\n\r\n  <p style=\"margin:0 0 18px;\">Siamo chiari e onesti: un dispositivo medico di classe I non \u00e8 un farmaco e non sostituisce il parere di un medico. Un cerotto STIMCARE <strong>aiuta ad alleviare il dolore<\/strong> ; non si tratta di una promessa di guarigione. In caso di dolore persistente o insolito, \u00e8 necessario consultare un operatore sanitario.<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">E domani? Gli studi continuano<\/h2>\r\n\r\n  <p style=\"margin:0 0 18px;\">Il marchio CE non \u00e8 un traguardo, ma un punto di partenza. STIMCARE prosegue il proprio lavoro di valutazione clinica per documentare sempre meglio l'efficacia dei propri cerotti e arricchire i dati che accompagnano ogni prodotto.<\/p>\r\n\r\n  <p style=\"margin:0 0 18px;\">\u00c8 anche questo che distingue in modo definitivo un dispositivo medico da un semplice accessorio per il benessere: il suo status gli apre, a lungo termine e previa le valutazioni richieste (in particolare da parte dell\u2019Alta Autorit\u00e0 Sanitaria, in vista dell\u2019inserimento nell\u2019elenco dei prodotti rimborsabili), una strada che rimane per sua natura preclusa ai prodotti di comfort. Ad oggi non siamo ancora rimborsati, ma \u00e8 proprio questa prospettiva che stiamo costruendo, studio dopo studio.<\/p>\r\n\r\n  <h2 style=\"font-size:25px;color:#132a3a;font-weight:700;border-left:4px solid #f2704a;padding-left:14px;margin:38px 0 16px;\">In breve<\/h2>\r\n\r\n  <p style=\"margin:0 0 22px;\">Scegliere un cerotto STIMCARE significa scegliere un prodotto che ha accettato di sottostare a un quadro normativo rigoroso, anzich\u00e9 eluderlo. Dietro queste due parole, \u00abclasse I\u00bb, si celano sicurezza, tracciabilit\u00e0 e una vera e propria destinazione medica. \u00c8 questa seriet\u00e0 che mettiamo in ciascuno dei nostri cerotti.<\/p>\r\n\r\n  <p style=\"text-align:center;margin:28px 0 8px;\">\r\n    <a href=\"https:\/\/www.stimcareonline.com\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#f2704a;color:#ffffff;text-decoration:none;font-weight:600;padding:14px 34px;border-radius:40px;font-size:16px;\">Scopri i cerotti STIMCARE<\/a>\r\n  <\/p>\r\n\r\n  <div style=\"background:#faf8f4;border:1px solid #e3ddd1;border-radius:12px;padding:18px 22px;margin:30px 0 0;font-size:14px;color:#6b6f76;line-height:1.6;\">\r\n    <strong style=\"color:#4a505c;\">Note.<\/strong> STIMCARE, dispositivi medici di classe I (Regolamento UE 2017\/745), marchio CE. Produttore: TORTEL Industries. Leggere attentamente il foglietto illustrativo prima dell\u2019uso. Sconsigliato alle donne in gravidanza; il cerotto SPORT contiene lattice naturale (sconsigliato in caso di allergia al lattice). In caso di dolore persistente, consultare un medico.\r\n  <\/div>\r\n\r\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Che cos\u2019\u00e8 un dispositivo medico di classe I? Scopri perch\u00e9 i cerotti STIMCARE rientrano in questa categoria e quali garanzie concrete ti offre questa classificazione.<\/p>","protected":false},"author":6,"featured_media":720,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-45955","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sport"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.10 - aioseo.com -->\n\t<meta name=\"description\" content=\"Qu&#039;est-ce qu&#039;un dispositif m\u00e9dical de classe I ? 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