{"id":3298,"date":"2026-01-02T20:07:01","date_gmt":"2026-01-02T20:07:01","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3298"},"modified":"2026-01-02T20:07:01","modified_gmt":"2026-01-02T20:07:01","slug":"intragastric-balloons-classification-and-grouping-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/intragastric-balloons-classification-and-grouping-in-costa-rica\/","title":{"rendered":"Intragastric Balloons: Classification and Grouping in Costa Rica."},"content":{"rendered":"<p><span data-contrast=\"auto\">Intragastric balloons are non-surgical medical devices widely applied in weight management therapies. Designed for temporary placement in the stomach, these devices reduce food intake and promote satiety, supporting weight reduction in individuals with\u00a0overweight\u00a0or obesity. This article reviews the structural design, clinical applications, and regulatory classification of intragastric balloons within\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Costa\u00a0Rica\u2019s healthcare system.<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Structure and Function of Intragastric Balloons<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">An intragastric balloon system\u00a0generally consists\u00a0of a soft, expandable silicone balloon connected to an inflation catheter. The balloon is inserted endoscopically and inflated with sterile saline or air to occupy gastric space. This induces a sensation of fullness and helps patients lower caloric intake.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Advanced models may include adjustable inflation mechanisms, allowing volume modifications after placement without removal. This feature supports individualized treatment plans and improves patient tolerance during therapy.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Key\u00a0components\u00a0include:<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"31\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Silicone Balloon: Biocompatible and flexible, with a typical diameter around\u00a090 mm.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"31\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Inflation Catheter: Non-collapsible and permanently attached, enabling initial deployment and\u00a0subsequent\u00a0volume adjustments.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"31\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">Extension Tubing:\u00a0polymer-based, with\u00a0luer-lock connectors for secure inflation control.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"31\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">Insertion Accessories<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"31\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"none\">Inflation Syringe: Standard\u00a0luer-lock syringe for balloon inflation and deflation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Types of Intragastric Balloons<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Intragastric balloons vary according to:<\/span><span data-ccp-props=\"{&quot;335559685&quot;:0}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"32\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Inflation Method:<\/span><\/b><span data-contrast=\"auto\">\u00a0Saline-filled vs. air-filled.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Saline-filled systems are preferred in most procedures due to safety advantages. If leakage occurs, urine discoloration provides an early warning sign. Air-filled systems lack this indicator.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"32\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Adjustability:<\/span><\/b><span data-contrast=\"auto\">\u00a0Fixed-volume vs. adjustable-volume.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Adjustable systems allow patient-specific customization, improving clinical\u00a0outcomes\u00a0and reducing adverse events.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559685&quot;:720,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">How Are\u00a0Intragastric Balloons\u202f<\/span><\/b><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Classified and Grouped in\u00a0Costa\u00a0Rica<\/span><\/b><\/a><b><span data-contrast=\"none\">?\u202f<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">In\u00a0Costa\u00a0Rica, intragastric balloons\u00a0<\/span><span data-contrast=\"auto\">are\u00a0considered\u00a0surgically invasive devices intended to remain in the body for more than 30 consecutive days. Based on this criterion, they are classified as\u00a0<\/span><b><span data-contrast=\"auto\">Class\u00a03\u00a0<\/span><\/b><span data-contrast=\"auto\">medical devices. This classification re<\/span><span data-contrast=\"auto\">flects their invasive nature and prolonged contact with internal tissues.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"none\">Grouping Strategy for Registration:\u202f<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Under\u00a0Costa\u00a0Rica\u2019s regulatory framework, grouping is\u00a0permitted\u00a0when devices share the same intended use, manufacturer, and distinctive denomination. For intragastric balloons, grouping applies when:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"39\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Models are packaged by the manufacturer together with implantation or filling accessories in the same sterilization tray or package.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"39\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Components included are not considered standalone medical devices.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">If any accessory (such as a syringe) is packaged separately and selected independently by the physician, it must be registered individually.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:0,&quot;335551620&quot;:0,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Intragastric balloons\u00a0represent\u00a0a structured, minimally invasive intervention for obesity management, offering both fixed and adjustable-volume options to enhance patient adherence. For stakeholders in the medical device industry, understanding\u00a0Costa\u00a0Rica\u2019s classification system is key to ensuring proper registration, clinical integration, and compliance with post-market surveillance requirements.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"40\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Need help evaluating your medical device for\u00a0Costa\u00a0Rican\u00a0sanitary registration?\u00a0<\/span><br \/>\n<span data-contrast=\"none\">Contact\u00a0\u202f<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">Veraque<\/span><\/a><span data-contrast=\"none\">\u202ffor expert regulatory guidance.\u202f<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"40\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Looking for intragastric balloon distributors? Our database is your essential resource: <\/span><a href=\"https:\/\/database.veraqueconsulting.com\/distributors\/?\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">explore it here.<\/span><\/a><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Intragastric balloons are non-surgical medical devices widely applied in weight management therapies. Designed for temporary placement in the stomach, these devices reduce food intake and promote satiety, supporting weight reduction in individuals with\u00a0overweight\u00a0or obesity. This article reviews the structural design, clinical applications, and regulatory classification of intragastric balloons within\u00a0Costa\u00a0Rica\u2019s healthcare system.\u00a0 \u00a0 Structure and Function [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3299,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3298","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-costa-rica"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Intragastric Balloons: Classification and Grouping in Costa Rica. - Veraque Costa Rica<\/title>\n<meta name=\"description\" content=\"Why intragastric balloons are Class 3 under Costa Rica\u2019s Ministry of Health: types, 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