{"id":3528,"date":"2025-10-20T00:40:31","date_gmt":"2025-10-20T00:40:31","guid":{"rendered":"https:\/\/linkeyegroup.com\/?page_id=3528"},"modified":"2026-07-31T01:17:32","modified_gmt":"2026-07-31T01:17:32","slug":"certificacion","status":"publish","type":"page","link":"https:\/\/linkeyegroup.com\/es\/certification\/","title":{"rendered":"Certificaci\u00f3n"},"content":{"rendered":"
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Certificaciones mundiales en las que puede confiar<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Certificado mundialmente, de confianza profesional - Equipos de optometr\u00eda y oftalmolog\u00eda aprobados por la CE, FDA, ISO 9001 y 13485.<\/p>\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

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In the ophthalmic field, certification means trust. LINKEYE\u2019s products are fully approved by CE<\/b>, FDA<\/b>, ETS<\/b>, ISO9001<\/b>, y ISO13485<\/b>, Cumpliendo las normas mundiales de seguridad y rendimiento.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Shanghai LINKEYE Instrument understand how critical certifications are for market access and hospital registration. That\u2019s why we provide complete documentation and full support for your local FDA <\/b>o CE <\/b>registro, ayud\u00e1ndole a ahorrar tiempo y a evitar riesgos normativos.<\/p>\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

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FDA <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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La certificaci\u00f3n de la FDA es una validaci\u00f3n que indica que un producto ha cumplido las estrictas normas de seguridad, rendimiento y calidad establecidas por EE.UU. y est\u00e1 aprobado para su venta en ese pa\u00eds.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Obtaining FDA approval reflects LINKEYE\u2019s continuous commitment to product excellence, regulatory compliance, and patient safety. It enables our devices \u2014 from Auto Refractometers and Slit Lamps to Phoropters and Tonometers \u2014 to be confidently used by eye care professionals in hospitals, clinics, and optical centers across the United States and worldwide.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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ISO 9001<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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ISO 9001 es una norma mundialmente reconocida para la gesti\u00f3n de la calidad. <\/p>\t\t\t\t<\/div>\n\t\t\t\t

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By implementing ISO 9001 principles, LINKEYE guarantees stable product quality, efficient production management, and reliable customer support. From material selection to final inspection, every product \u2014 including our Auto Refractometers, Slit Lamps, and Refraction Units \u2014 is produced under a well-defined quality framework that ensures precision, safety, and long-term performance for global eye care professionals.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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ISO13485 <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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La certificaci\u00f3n ISO 13485 se centra en la seguridad, la trazabilidad y el cumplimiento de la normativa exigidos en el dise\u00f1o y la producci\u00f3n de instrumentos m\u00e9dicos.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Through strict implementation of ISO 13485, LINKEYE maintains controlled production environments, precise testing procedures, and complete documentation systems for all devices, including Auto Refractometers, Phoropters, and Slit Lamps. This allows us to deliver reliable, compliant, and high-performance ophthalmic and optometric equipment that doctors and clinics can trust worldwide.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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equipamiento para optometristas CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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La certificaci\u00f3n CE confirma que los instrumentos optom\u00e9tricos cumplen el Reglamento de Productos Sanitarios de la UE (MDR 2017\/745), lo que garantiza la precisi\u00f3n, la seguridad y el cumplimiento normativo.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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LINKEYE\u2019s Optometric devices \u2014 including Auto Refractometers, Lensmeters, and Phoropters \u2014 are CE certified for precision, safety, and reliable clinical performance, supporting trusted eye care worldwide.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Mesa oft\u00e1lmica CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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La certificaci\u00f3n CE confirma que los instrumentos optom\u00e9tricos y las mesas oft\u00e1lmicas cumplen las normas de la UE sobre maquinaria y seguridad el\u00e9ctrica, lo que garantiza un funcionamiento estable y seguro en las cl\u00ednicas.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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LINKEYE\u2019s Ophthalmic Tables \u2014 motorized tables, refraction units, and chairs \u2014 are CE certified for mechanical safety, durability, and reliable performance, giving professionals confidence in daily clinical use.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Refract\u00f3metro CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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La certificaci\u00f3n CE confirma que los refract\u00f3metros cumplen con el Reglamento de Dispositivos M\u00e9dicos de la UE (MDR 2017\/745), lo que garantiza la seguridad, la precisi\u00f3n y el cumplimiento normativo para uso cl\u00ednico.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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LINKEYE\u2019s Auto Refractometers are CE certified, guaranteeing precise measurements, safe operation, and reliable performance. <\/p>\t\t\t\t<\/div>\n\t\t\t\t

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LCD Vision Chart CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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La certificaci\u00f3n CE garantiza que las tablas de visi\u00f3n LCD cumplen los requisitos del Reglamento de productos sanitarios de la UE (MDR 2017\/745), lo que garantiza pruebas de visi\u00f3n seguras, fiables y precisas en entornos cl\u00ednicos.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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LINKEYE\u2019s LCD Vision Charts are CE certified, providing precise visual acuity testing, user-friendly operation, and consistent performance. <\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Preguntas frecuentes<\/h2>\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":"

Global Certifications You Can Trust Globally Certified, Professionally Trusted \u2014 CE, FDA, ISO 9001 & 13485 Approved Optometry & Ophthalmic Equipment. In the ophthalmic field, certification means trust. LINKEYE\u2019s products are fully approved by CE, FDA, ETS, ISO9001, and ISO13485, meeting global safety and performance standards. Shanghai LINKEYE Instrument understand how critical certifications are for […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3528","page","type-page","status-publish","hentry"],"yoast_head":"\nCE, FDA, ISO Certification of Ophthalmic Equipment - LINKEYE<\/title>\n<meta name=\"description\" content=\"Explore Shanghai LINKEYE\u2019s CE, FDA, ETS, ISO9001, and ISO13485 certifications ensuring quality, safety, and compliance in every ophthalmic and optometric device.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/linkeyegroup.com\/es\/certificacion\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CE, FDA, ISO Certification of Ophthalmic Equipment - 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