{"id":31320,"date":"2026-05-21T11:46:41","date_gmt":"2026-05-21T11:46:41","guid":{"rendered":"http:\/\/suresultmed.com\/?page_id=31320"},"modified":"2026-11-10T03:41:58","modified_gmt":"2026-11-10T03:41:58","slug":"certifications-compliance","status":"publish","type":"page","link":"https:\/\/suresultmed.com\/it\/certifications-compliance\/","title":{"rendered":"Certificazioni e conformit\u00e0"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"31320\" class=\"elementor elementor-31320\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"wd-negative-gap elementor-element elementor-element-30d806ec e-flex e-con-boxed e-con e-parent\" data-id=\"30d806ec\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-11208793 color-scheme-inherit text-left elementor-widget elementor-widget-text-editor\" data-id=\"11208793\" data-element_type=\"widget\" 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*\/\n@media (prefers-reduced-motion:reduce){\n  .srx-certs .sct-cert-card,.srx-certs a.srx-c-btn,.srx-certs a.srx-pill,.srx-certs .sct-filters button,.srx-certs #sct-search-input{transition:none}\n  .srx-certs .sct-cert-card:hover,.srx-certs a.srx-c-btn:hover,.srx-certs a.srx-c-btn:focus,.srx-certs a.srx-pill:hover,.srx-certs a.srx-pill:focus,.srx-certs .sct-filters button:hover{transform:none}\n}\n\n\/* --- responsive --- *\/\n@media (max-width:768px){\n  .srx-certs .srx-hl{grid-template-columns:repeat(2,minmax(0,1fr))}\n  .srx-certs .srx-c-sec{margin-bottom:44px}\n  .srx-certs .srx-c-head{flex-direction:column;gap:20px}\n  .srx-certs .srx-c-count{flex-direction:row;align-items:baseline;gap:12px;align-self:flex-start;min-width:0;padding:12px 18px}\n  .srx-certs .srx-c-count span{width:auto;margin-top:0;padding-top:0;border-top:0}\n  .srx-certs .srx-c-close{padding-top:48px;padding-bottom:48px}\n}\n@media (max-width:480px){\n  .srx-certs .srx-hl{grid-template-columns:1fr;gap:18px}\n  .srx-certs .srx-hl-item{flex-direction:row;align-items:flex-start;gap:16px}\n  .srx-certs .srx-c-controls{padding:18px}\n  .srx-certs .sct-filters button{flex:1 1 auto}\n  .srx-certs a.srx-pill{width:100%;justify-content:center}\n}\n\n.srx-certs .srx-c-plate{display:flex;align-items:center;justify-content:center;width:132px;height:56px;flex:none;padding:8px 14px;background:#fff;border:1px solid #E7EFF5;border-radius:12px;box-shadow:inset 0 1px 0 #fff,0 1px 2px rgba(16,42,60,.04)}\n.srx-certs .srx-c-plate img{display:block;width:auto;height:auto;max-width:104px;max-height:40px;object-fit:contain}\n\n.srx-certs .srx-c-gatenote{margin:10px 0 0;font-size:14.5px;color:#5B6D79}\n\n#suresult-certifications-trust-center {letter-spacing:0}\n#suresult-certifications-trust-center .srx-cert-facts {margin:16px 0 24px;font-size:14px;line-height:1.55;display:grid;grid-template-columns:1fr;gap:2px}\n#suresult-certifications-trust-center .srx-cert-facts dt {font-weight:600;color:#4b5563;margin:10px 0 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.srx-cert-faq p {max-width:800px;margin:14px 0 0;line-height:1.7}\n#suresult-certifications-trust-center [hidden] {display:none!important}\n<\/style>\n<div class=\"srx-certs\" id=\"suresult-certifications-trust-center\">\n<!-- 1. MASTHEAD -->\n<section class=\"srx-c-sec\">\n<div class=\"srx-eyebrow\">Suresult Trust Center<\/div>\n<div class=\"srx-t-title\">Ultrasound Certifications &amp; Regulatory Documents<\/div>\n<p class=\"srx-lead\">Review the documentation that covers every Suresult product. This library brings together regulatory records, the EU Declaration of Conformity, quality management certificates, and technical and market documentation summaries. Each entry identifies the document type, reference and product family; full PDFs are available after sign-in.<\/p>\n<p class=\"srx-c-meta\">11 documents available | Library updated: <time datetime=\"2026-10-09\">October 9, 2026<\/time><\/p><p class=\"srx-c-meta\">One page holds the verified facts: <a href=\"https:\/\/suresultmed.com\/suresult-ai-reference\/\">Suresult AI reference: company facts, all 30 models and store terms<\/a>.<\/p>\n<p class=\"srx-c-meta\">Published clinical use: <a href=\"https:\/\/ianmedicine.org\/wp-content\/uploads\/2026\/10\/Ramakko.pdf\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">Suresult D3Ultra imaging in a peer-reviewed case report, JIANM 2026;23(2):45\u201353<\/a><\/p>\n<ul aria-label=\"Compliance highlights\" class=\"srx-hl\">\n<li class=\"srx-hl-item\">\n<span class=\"srx-c-plate\"><img alt=\"FDA logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/suresultmed.com\/wp-content\/uploads\/2025\/02\/fda-logo-icon.png\"\/><\/span>\n<div>\n<div class=\"srx-hl-label\">FDA 510(k)<\/div>\n<div class=\"srx-hl-text\">K211321 covers every Suresult product.<\/div>\n<\/div>\n<\/li>\n<li class=\"srx-hl-item\">\n<span class=\"srx-c-plate\"><img alt=\"Health Canada logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/3f\/Health_Canada_logo.svg\"\/><\/span>\n<div>\n<div class=\"srx-hl-label\">Canada \/ Health Canada<\/div>\n<div class=\"srx-hl-text\">Medical device license documentation available for buyer review.<\/div>\n<\/div>\n<\/li>\n<li class=\"srx-hl-item\">\n<span class=\"srx-c-plate\"><img alt=\"CE marking\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/suresultmed.com\/wp-content\/uploads\/2025\/02\/ce-logo-icon.webp\"\/><\/span>\n<div>\n<div class=\"srx-hl-label\">EU MDR \/ CE<\/div>\n<div class=\"srx-hl-text\">European conformity and MDR-related quality documentation.<\/div>\n<\/div>\n<\/li>\n<li class=\"srx-hl-item\">\n<span class=\"srx-c-plate\"><img alt=\"ISO logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e3\/ISO_Logo_%28Red_square%29.svg\"\/><\/span>\n<div>\n<div class=\"srx-hl-label\">ISO 13485 QMS<\/div>\n<div class=\"srx-hl-text\">Quality management system documentation for medical devices.<\/div>\n<\/div>\n<\/li>\n<li class=\"srx-hl-item\">\n<span class=\"srx-med srx-med--seal\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-globe\"><\/use><\/svg><\/span>\n<div>\n<div class=\"srx-hl-label\">Global Documentation<\/div>\n<div class=\"srx-hl-text\">Regional registrations, safety evidence, and supporting summaries.<\/div>\n<\/div>\n<\/li>\n<li class=\"srx-hl-item\">\n<span class=\"srx-c-plate\"><img alt=\"Therapeutic Goods Administration logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.tga.gov.au\/sites\/default\/files\/2025-05\/DHAC-TGA-strip-logo-black-730x151.png\"\/><\/span>\n<div>\n<div class=\"srx-hl-label\">Australia \/ TGA<\/div>\n<div class=\"srx-hl-text\">ARTG medical device registration documentation for buyer review.<\/div>\n<\/div>\n<\/li>\n<\/ul>\n<hr class=\"srx-c-rule\"\/>\n<\/section>\n<!-- 2. CERTIFICATE LIBRARY -->\n<section aria-labelledby=\"sct-library-title\" class=\"srx-c-sec\">\n<div class=\"srx-c-head\">\n<div class=\"srx-c-head-main\">\n<div class=\"srx-eyebrow\">Certificate library<\/div>\n<h2 id=\"sct-library-title\">Documentation Available for Buyer Review<\/h2>\n<p class=\"srx-c-intro\">Review documents by market, standard or product family.<\/p>\n<p class=\"srx-c-gatenote\">Full PDF documents are available after a free sign-in. Public summaries remain available below.<\/p>\n<\/div>\n<div aria-live=\"polite\" class=\"srx-c-count\"><strong id=\"sct-visible-count\">11<\/strong><span>shown<\/span><\/div>\n<\/div>\n<div class=\"srx-c-controls\">\n<label class=\"sct-search\" for=\"sct-search-input\">Search documents<\/label>\n<div class=\"srx-c-searchwrap\">\n<svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-search\"><\/use><\/svg>\n<input autocomplete=\"off\" id=\"sct-search-input\" placeholder=\"Search FDA, ANVISA, ISO 13485, Canada, Intertek...\" type=\"search\"\/>\n<\/div>\n<div aria-label=\"Certificate categories\" class=\"sct-filters\">\n<button aria-pressed=\"true\" class=\"is-active\" data-filter=\"all\" type=\"button\">All<\/button>\n<button aria-pressed=\"false\" data-filter=\"regulatory\" type=\"button\">Regulatory Registrations<\/button>\n<button aria-pressed=\"false\" data-filter=\"eu\" type=\"button\">EU \/ CE &amp; MDR<\/button>\n<button aria-pressed=\"false\" data-filter=\"quality\" type=\"button\">Quality &amp; Safety<\/button>\n<button aria-pressed=\"false\" data-filter=\"global\" type=\"button\">Global \/ IP Documentation<\/button>\n<\/div>\n<label class=\"srx-cert-series-label\" for=\"sct-series-filter\">Product family<\/label><select id=\"sct-series-filter\"><option value=\"all\">All product families<\/option><option value=\"d\">D Series<\/option><option value=\"l\">L Series<\/option><option value=\"c\">C Series<\/option><\/select><\/div>\n<p class=\"srx-c-note\"><span class=\"srx-med srx-med--sm srx-med--amber\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-bolt\"><\/use><\/svg><\/span><span class=\"srx-c-notetext\">Document dates refer to the supplied records. The library update date records when the files on this page were replaced.<\/span><\/p>\n<div class=\"srx-c-lib\" id=\"sct-cert-grid\">\n<div aria-label=\"Regulatory Registrations\" class=\"srx-c-group\" role=\"group\">\n<div class=\"srx-c-grouphead\">\n<span class=\"srx-med srx-med--sm\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-award\"><\/use><\/svg><\/span>\n<span class=\"srx-eyebrow\">Regulatory Registrations<\/span>\n<span class=\"srx-c-groupline\"><\/span>\n<\/div>\n<div class=\"srx-c-grid\">\n<article class=\"sct-cert-card\" data-category=\"regulatory\" data-search=\"suresult australia tga artg 360011 public summary therapeutic goods administration artg 360011 d series l series c series\" data-series=\"d l c\" id=\"tga-artg\">\n<div class=\"srx-c-chips\" data-index=\"01\"><span class=\"srx-c-region\">Australia<\/span><span class=\"srx-c-type\">Public summary<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"Therapeutic Goods Administration logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.tga.gov.au\/sites\/default\/files\/2025-05\/DHAC-TGA-strip-logo-black-730x151.png\"\/><\/div>\n<h3>Suresult Australia TGA ARTG 360011 Public Summary<\/h3>\n<p>Public summary for ARTG entry 360011, including the Australian sponsor, device classification and intended purpose. The supplied record names the portable wireless ultrasound system in the D, L and C series.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Therapeutic Goods Administration<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>25 August 2026 (summary produced)<\/dd><\/dl><a aria-label=\"View Public Summary: Suresult Australia TGA ARTG 360011 Public Summary\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/tga-artg\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View Public Summary<\/a>\n<\/article>\n<article class=\"sct-cert-card\" data-category=\"regulatory\" data-search=\"suresult fda 510(k) wireless ultrasound documentation u.s. food and drug administration 510(k) correspondence; iyn \/ iyo \/ itx d series l series c series\" data-series=\"d l c\" id=\"fda-510k\">\n<div class=\"srx-c-chips\" data-index=\"02\"><span class=\"srx-c-region\">United States<\/span><span class=\"srx-c-type\">Regulatory document<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"FDA logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/suresultmed.com\/wp-content\/uploads\/2025\/02\/fda-logo-icon.png\"\/><\/div>\n<h3>Suresult FDA 510(k) Wireless Ultrasound Documentation<\/h3>\n<p>FDA 510(k) correspondence concerning an ultrasonic pulsed Doppler imaging system. The document identifies Class II and product codes IYN, IYO and ITX. FDA 510(k) K211321 covers every Suresult product.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>U.S. Food and Drug Administration<\/dd><dt>Product family<\/dt><dd>All Suresult products<\/dd><dt>Document date<\/dt><dd>13 October 2022<\/dd><\/dl><a aria-label=\"View FDA Document: Suresult FDA 510(k) Wireless Ultrasound Documentation\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/fda-510k\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View FDA Document<\/a>\n<\/article>\n<article class=\"sct-cert-card\" data-category=\"regulatory\" data-search=\"suresult brazil anvisa authorization reference suresult documentation system registro 81535520003; srs-anvisa-2026-0519 d series l series c series\" data-series=\"d l c\" id=\"anvisa-brazil\">\n<div class=\"srx-c-chips\" data-index=\"03\"><span class=\"srx-c-region\">Brazil \/ ANVISA<\/span><span class=\"srx-c-type\">Authorization reference<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"ANVISA logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/suresultmed.com\/wp-content\/uploads\/2025\/02\/anvisa.png\"\/><\/div>\n<h3>Suresult Brazil ANVISA Authorization Reference<\/h3>\n<p>Brazil-market documentation reference listing ANVISA Registro 81535520003 and process 25351.022590\/2020-24. This dedicated file covers the portable wireless ultrasound D, L and C series.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Suresult Documentation System<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>22 January 2025 (listed in document)<\/dd><\/dl><a aria-label=\"View ANVISA Reference: Suresult Brazil ANVISA Authorization Reference\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/anvisa-brazil\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View ANVISA Reference<\/a>\n<\/article>\n<article class=\"sct-cert-card\" data-category=\"regulatory\" data-search=\"suresult health canada medical device licence 107656 health canada licence 107656 d series l series c series\" data-series=\"d l c\" id=\"health-canada\">\n<div class=\"srx-c-chips\" data-index=\"04\"><span class=\"srx-c-region\">Canada<\/span><span class=\"srx-c-type\">Device licence<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"Health Canada logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/3f\/Health_Canada_logo.svg\"\/><\/div>\n<h3>Suresult Health Canada Medical Device Licence 107656<\/h3>\n<p>Medical Device Licence 107656 identifies a Class III device family. Its accompanying device list includes CPROBE types C, CL, CT and L; consult that list for the recorded device identifiers.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Health Canada<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>22 April 2022 (first issue)<\/dd><\/dl><a aria-label=\"View Device Licence: Suresult Health Canada Medical Device Licence 107656\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/health-canada\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View Device Licence<\/a>\n<\/article>\n<\/div>\n<\/div>\n<div aria-label=\"EU \/ CE &amp; MDR\" class=\"srx-c-group\" role=\"group\">\n<div class=\"srx-c-grouphead\">\n<span class=\"srx-med srx-med--sm\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-check\"><\/use><\/svg><\/span>\n<span class=\"srx-eyebrow\">EU \/ CE &amp; MDR<\/span>\n<span class=\"srx-c-groupline\"><\/span>\n<\/div>\n<div class=\"srx-c-grid\">\n<article class=\"sct-cert-card\" data-category=\"eu\" data-search=\"suresult eu mdr qms certificate | intertek nb 2862 intertek medical notified body ab 28620203593; nb 2862 d series l series c series\" data-series=\"d l c\" id=\"eu-mdr-qms\">\n<div class=\"srx-c-chips\" data-index=\"05\"><span class=\"srx-c-region\">EU \/ MDR<\/span><span class=\"srx-c-type\">QMS certificate<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"Intertek logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/cdn.intertek.com\/intranet-intertek-com\/images\/global\/roundel-favicon-x.png\"\/><\/div>\n<h3>Suresult EU MDR QMS Certificate | Intertek NB 2862<\/h3>\n<p>EU Quality Management System certificate referencing Regulation (EU) 2017\/745, Annex IX Chapters I and III. The supplied certificate identifies Intertek NB 2862 and the portable wireless ultrasound D, L and C series.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Intertek Medical Notified Body AB<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>22 January 2025<\/dd><dt>Certificate number<\/dt><dd>28620203593<\/dd><dt>Revision<\/dt><dd>00<\/dd><dt>Valid through<\/dt><dd>18 November 2029<\/dd><\/dl><a aria-label=\"View QMS Certificate: Suresult EU MDR QMS Certificate | Intertek NB 2862\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/eu-mdr-qms\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View QMS Certificate<\/a>\n<\/article>\n<article class=\"sct-cert-card\" data-category=\"eu\" data-search=\"suresult eu declaration of conformity | d, l &amp; c series suresult industrial co., ltd. (declarant) ss-ctf-pl01-01-01, ver. a\/1 d series l series c series\" data-series=\"d l c\" id=\"eu-doc\">\n<div class=\"srx-c-chips\" data-index=\"06\"><span class=\"srx-c-region\">EU \/ CE<\/span><span class=\"srx-c-type\">Declaration<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"CE marking\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/suresultmed.com\/wp-content\/uploads\/2025\/02\/ce-logo-icon.webp\"\/><\/div>\n<h3>Suresult EU Declaration of Conformity | D, L &amp; C Series<\/h3>\n<p>Manufacturer declaration referencing Regulation (EU) 2017\/745 for the D, L and C series. The document includes classification, the conformity-assessment route, and a list of applicable standards, including biological evaluation and electrical safety references.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Suresult Industrial Co., Ltd. (declarant)<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>10 April 2025 (date stated)<\/dd><\/dl><a aria-label=\"View Declaration: Suresult EU Declaration of Conformity | D, L &amp; C Series\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/eu-doc\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View Declaration<\/a>\n<\/article>\n\n<\/div>\n<\/div>\n<div aria-label=\"Quality &amp; Safety\" class=\"srx-c-group\" role=\"group\">\n<div class=\"srx-c-grouphead\">\n<span class=\"srx-med srx-med--sm\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-beaker\"><\/use><\/svg><\/span>\n<span class=\"srx-eyebrow\">Quality &amp; Safety<\/span>\n<span class=\"srx-c-groupline\"><\/span>\n<\/div>\n<div class=\"srx-c-grid\">\n<article class=\"sct-cert-card\" data-category=\"quality\" data-search=\"suresult iso 13485:2016 medical device qms certificate intertek 0096442-01; iso 13485:2016 d series l series c series\" data-series=\"d l c\" id=\"iso-13485\">\n<div class=\"srx-c-chips\" data-index=\"07\"><span class=\"srx-c-region\">Quality System<\/span><span class=\"srx-c-type\">QMS certificate<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"ISO logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e3\/ISO_Logo_%28Red_square%29.svg\"\/><\/div>\n<h3>Suresult ISO 13485:2016 Medical Device QMS Certificate<\/h3>\n<p>ISO 13485:2016 quality management system certificate. The stated scope covers design, manufacture and servicing of diagnostic ultrasound systems and the portable wireless ultrasound D, L and C series.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Intertek<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>18 November 2022<\/dd><\/dl><a aria-label=\"View ISO Certificate: Suresult ISO 13485:2016 Medical Device QMS Certificate\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/iso-13485\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View ISO Certificate<\/a>\n<\/article>\n\n<article class=\"sct-cert-card\" data-category=\"quality\" data-search=\"suresult iec 60601-1 safety evidence &amp; mdr technical summary technical documentation reviewer (as stated) mdr-60601-tr-2026-0519 d series l series c series\" data-series=\"d l c\" id=\"iec-60601-1\">\n<div class=\"srx-c-chips\" data-index=\"08\"><span class=\"srx-c-region\">Safety Evidence<\/span><span class=\"srx-c-type\">Technical summary<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"IEC logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/3e\/International_Electrotechnical_Commission_Logo.svg\"\/><\/div>\n<h3>Suresult IEC 60601-1 Safety Evidence &amp; MDR Technical Summary<\/h3>\n<p>Document-based technical review summary referencing IEC 60601-1 and EU MDR. It organizes electrical safety, essential performance, risk-management and software\/usability evidence for the D, L and C series.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Technical Documentation Reviewer (as stated)<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>19 May 2026<\/dd><\/dl><a aria-label=\"View Technical Summary: Suresult IEC 60601-1 Safety Evidence &amp; MDR Technical Summary\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/iec-60601-1\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View Technical Summary<\/a>\n<\/article>\n<article class=\"sct-cert-card\" data-category=\"quality\" data-search=\"suresult mdsap &amp; sds \/ msds documentation summary quality and material compliance reviewer (as stated) srs-mdsap-msds-2026-0519 d series l series c series\" data-series=\"d l c\" id=\"mdsap-sds-msds\">\n<div class=\"srx-c-chips\" data-index=\"09\"><span class=\"srx-c-region\">Safety Docs<\/span><span class=\"srx-c-type\">Documentation summary<\/span><\/div>\n<div class=\"srx-c-logo\"><span class=\"srx-c-mark\">SDS<\/span><\/div>\n<h3>Suresult MDSAP &amp; SDS \/ MSDS Documentation Summary<\/h3>\n<p>Summary of quality-system and material-safety documentation for the D, L and C series. It describes MDSAP framework mapping, ISO 13485 links, supplier records and SDS\/MSDS file controls.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Quality and Material Compliance Reviewer (as stated)<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>19 May 2026<\/dd><\/dl><a aria-label=\"View Documentation Summary: Suresult MDSAP &amp; SDS \/ MSDS Documentation Summary\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/mdsap-sds-msds\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View Documentation Summary<\/a>\n<\/article>\n<\/div>\n<\/div>\n<div aria-label=\"Global \/ IP Documentation\" class=\"srx-c-group\" role=\"group\">\n<div class=\"srx-c-grouphead\">\n<span class=\"srx-med srx-med--sm\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-globe\"><\/use><\/svg><\/span>\n<span class=\"srx-eyebrow\">Global \/ IP Documentation<\/span>\n<span class=\"srx-c-groupline\"><\/span>\n<\/div>\n<div class=\"srx-c-grid\">\n<article class=\"sct-cert-card\" data-category=\"global\" data-search=\"suresult global medical device authorizations summary global regulatory documentation reviewer (as stated) srs-gma-2026-0519 d series l series c series\" data-series=\"d l c\" id=\"global-summary\">\n<div class=\"srx-c-chips\" data-index=\"10\"><span class=\"srx-c-region\">Global<\/span><span class=\"srx-c-type\">Market documentation summary<\/span><\/div>\n<div class=\"srx-c-logo\"><span class=\"srx-c-mark\">GLO<\/span><\/div>\n<h3>Suresult Global Medical Device Authorizations Summary<\/h3>\n<p>International market-documentation summary for the D, L and C series. It organizes country-level records, labeling and instructions for use, representative information and post-market documentation by market.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Global Regulatory Documentation Reviewer (as stated)<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>19 May 2026<\/dd><\/dl><a aria-label=\"View Market Summary: Suresult Global Medical Device Authorizations Summary\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/global-summary\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View Market Summary<\/a>\n<\/article>\n<article class=\"sct-cert-card\" data-category=\"global\" data-search=\"suresult euipo intellectual property documentation summary intellectual property documentation reviewer (as stated) srs-euipo-ip-2026-0519 d series l series c series\" data-series=\"d l c\" id=\"euipo-ip\">\n<div class=\"srx-c-chips\" data-index=\"11\"><span class=\"srx-c-region\">IP \/ EUIPO<\/span><span class=\"srx-c-type\">IP documentation summary<\/span><\/div>\n<div class=\"srx-c-logo\"><img alt=\"EUIPO logo\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/a.storyblok.com\/f\/139646\/417x114\/95f9a66f6f\/euipo-logo.png\/m\/640x0\/smart\/filters:quality(75)\"\/><\/div>\n<h3>Suresult EUIPO Intellectual Property Documentation Summary<\/h3>\n<p>European intellectual-property documentation summary for the D, L and C series. It organizes brand and design records, technical dossiers, product-family references and portfolio maintenance information.<\/p>\n<dl class=\"srx-cert-facts\"><dt>Body \/ source<\/dt><dd>Intellectual Property Documentation Reviewer (as stated)<\/dd><dt>Product family<\/dt><dd>D Series, L Series, C Series<\/dd><dt>Document date<\/dt><dd>19 May 2026<\/dd><\/dl><a aria-label=\"View IP Summary: Suresult EUIPO Intellectual Property Documentation Summary\" class=\"srx-c-btn\" href=\"https:\/\/suresultmed.com\/cert-download\/euipo-ip\/\" rel=\"noopener\" target=\"_blank\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-doc\"><\/use><\/svg>View IP Summary<\/a>\n<\/article>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"srx-c-empty\" hidden=\"\" id=\"sct-empty-state\">No matching documents found. Clear the search or choose All.<\/div>\n<\/section>\n<!-- 3. DARK CLOSING BAND -->\n<section aria-labelledby=\"srx-cert-faq-title\" class=\"srx-c-sec srx-cert-faq\"><h2 id=\"srx-cert-faq-title\">Questions About Suresult Documentation<\/h2><details><summary>Which ultrasound models are listed?<\/summary><p>The supplied documents cover every Suresult product. Check the model and device-identifier list within the relevant PDF when matching a specific probe to a record.<\/p><\/details><details><summary>How is an EU declaration different from a QMS certificate?<\/summary><p>The declaration states the manufacturer&#8217;s conformity position for the listed device family. A QMS certificate describes the assessed quality management system and its scope. Both document types are identified separately above.<\/p><\/details><details><summary>Where can I find the Brazil ANVISA reference?<\/summary><p>The Brazil ANVISA entry now opens its own dedicated reference PDF, separate from the Global Medical Device Authorizations Summary.<\/p><\/details><details><summary>How do I download a document?<\/summary><p>Select the document button, then sign in or create a free account. After sign-in, the requested PDF opens for review.<\/p><\/details><\/section><section class=\"srx-c-sec srx-c-close\">\n<span class=\"srx-med srx-med--seal srx-med--dark\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-seal\"><\/use><\/svg><\/span>\n<div class=\"srx-eyebrow\">Document library<\/div>\n<h2>Which Documents Should You Review?<\/h2>\n<p class=\"srx-c-deck\">Start with the relevant market record and its product scope. The EU Declaration of Conformity describes the manufacturer declaration; QMS certificates describe quality-system scope. Technical and market summaries organize supporting evidence and should be read alongside the underlying documents.<\/p>\n<p class=\"srx-c-contact\"><a class=\"srx-pill\" href=\"mailto:info@suresultmed.com\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-mail\"><\/use><\/svg>info@suresultmed.com<\/a><a class=\"srx-pill\" href=\"tel:+17477776278\"><svg aria-hidden=\"true\" class=\"srx-i\"><use href=\"#c-phone\"><\/use><\/svg>+1 747 777 6278<\/a><\/p>\n<\/section>\n<\/div>\n<script>(function(){\nconst root=document.getElementById('suresult-certifications-trust-center');\nif(!root||root.dataset.ready==='true')return;root.dataset.ready='true';\nconst cards=Array.from(root.querySelectorAll('.sct-cert-card'));\nconst search=root.querySelector('#sct-search-input'),series=root.querySelector('#sct-series-filter');\nconst buttons=Array.from(root.querySelectorAll('.sct-filters button'));\nconst count=root.querySelector('#sct-visible-count'),empty=root.querySelector('#sct-empty-state');\nlet category='all';\nconst normalize=v=>String(v||'').toLowerCase().replace(\/[^a-z0-9]+\/g,' ').trim();\nfunction apply(){let shown=0;const words=normalize(search.value).split(' ').filter(Boolean);\ncards.forEach(card=>{const hay=normalize(card.textContent+' '+card.dataset.search);\ncard.hidden=!((category==='all'||card.dataset.category===category)&&(series.value==='all'||card.dataset.series.split(' ').includes(series.value))&&words.every(w=>hay.includes(w)));if(!card.hidden)shown++;});\nroot.querySelectorAll('.srx-c-group').forEach(g=>{g.hidden=!Array.from(g.querySelectorAll('.sct-cert-card')).some(c=>!c.hidden);});\ncount.textContent=String(shown);empty.hidden=shown!==0;}\nbuttons.forEach(b=>b.addEventListener('click',()=>{category=b.dataset.filter;buttons.forEach(x=>{x.classList.toggle('is-active',x===b);x.setAttribute('aria-pressed',String(x===b));});apply();}));\nsearch.addEventListener('input',apply);series.addEventListener('change',apply);apply();\n})();<\/script>\n\n<script id=\"srx-certificate-schema\" type=\"application\/ld+json\">{\"@context\": \"https:\/\/schema.org\", \"@graph\": [{\"@type\": \"CollectionPage\", \"@id\": \"https:\/\/suresultmed.com\/certifications-compliance\/#certificate-collection\", \"url\": \"https:\/\/suresultmed.com\/certifications-compliance\/\", \"name\": \"Suresult Ultrasound Certifications & Regulatory Documents\", \"dateModified\": \"2026-10-09\", \"mainEntity\": {\"@id\": \"https:\/\/suresultmed.com\/certifications-compliance\/#document-library\"}}, {\"@type\": \"ItemList\", \"@id\": \"https:\/\/suresultmed.com\/certifications-compliance\/#document-library\", \"numberOfItems\": 11, \"itemListElement\": [{\"@type\": \"ListItem\", \"position\": 1, \"item\": {\"@type\": \"DigitalDocument\", \"@id\": \"https:\/\/suresultmed.com\/certifications-compliance\/#tga-artg\", \"url\": \"https:\/\/suresultmed.com\/certifications-compliance\/#tga-artg\", \"name\": \"Suresult Australia TGA ARTG 360011 Public Summary\", \"description\": \"Public summary for ARTG entry 360011, including the Australian sponsor, device classification and intended purpose. 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