{"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":"sertifikasi","status":"publish","type":"page","link":"https:\/\/linkeyegroup.com\/id\/certification\/","title":{"rendered":"Sertifikasi"},"content":{"rendered":"
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Sertifikasi Global yang Dapat Anda Percaya<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Tersertifikasi Secara Global, Dipercaya Para Profesional \u2014 Peralatan Optometri dan Oftalmologi yang Telah Disetujui oleh CE, FDA, ISO 9001, dan 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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Di bidang oftalmologi, sertifikasi berarti kepercayaan. Produk-produk LINKEYE telah sepenuhnya disetujui oleh CE<\/b>, FDA<\/b>, ETS<\/b>, ISO9001<\/b>, dan ISO13485<\/b>, yang memenuhi standar keselamatan dan kinerja global.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Shanghai LINKEYE Instrument memahami betapa pentingnya sertifikasi bagi akses ke pasar dan pendaftaran di rumah sakit. Itulah sebabnya kami menyediakan dokumentasi lengkap serta dukungan penuh untuk kebutuhan Anda di tingkat lokal FDA <\/b>atau CE <\/b>pendaftaran, sehingga Anda dapat menghemat waktu dan menghindari risiko kepatuhan.<\/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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Sertifikasi FDA merupakan bukti yang menunjukkan bahwa suatu produk telah memenuhi standar keamanan, kinerja, dan kualitas yang ketat yang ditetapkan oleh Amerika Serikat, serta telah disetujui untuk dijual di AS.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Perolehan persetujuan FDA mencerminkan komitmen berkelanjutan LINKEYE terhadap keunggulan produk, kepatuhan terhadap peraturan, dan keselamatan pasien. Hal ini memungkinkan perangkat kami \u2014 mulai dari Auto Refraktometer dan Slit Lamp hingga Phoropter dan Tonometer \u2014 digunakan dengan percaya diri oleh para profesional perawatan mata di rumah sakit, klinik, dan pusat optik di seluruh Amerika Serikat maupun di seluruh dunia.<\/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 adalah standar manajemen mutu yang diakui secara global. <\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Dengan menerapkan prinsip-prinsip ISO 9001, LINKEYE menjamin kualitas produk yang stabil, manajemen produksi yang efisien, serta layanan pelanggan yang andal. Mulai dari pemilihan bahan hingga pemeriksaan akhir, setiap produk \u2014 termasuk Auto Refraktometer, Slit Lamp, dan Unit Refraksi kami \u2014 diproduksi berdasarkan kerangka kerja kualitas yang terdefinisi dengan baik, yang menjamin ketepatan, keamanan, dan kinerja jangka panjang bagi para profesional perawatan mata di seluruh dunia.<\/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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Sertifikasi ISO 13485 berfokus pada keselamatan, keterlacakan, dan kepatuhan terhadap peraturan yang diperlukan dalam perancangan dan produksi alat-alat medis.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Melalui penerapan ketat standar ISO 13485, LINKEYE memastikan lingkungan produksi yang terkendali, prosedur pengujian yang akurat, serta sistem dokumentasi yang lengkap untuk semua perangkat, termasuk Auto Refraktometer, Phoropter, dan Slit Lamp. Hal ini memungkinkan kami untuk menyediakan peralatan oftalmologi dan optometri yang andal, sesuai standar, dan berkinerja tinggi yang dapat dipercaya oleh para dokter dan klinik di seluruh dunia.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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peralatan ahli kacamata CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Sertifikasi CE membuktikan bahwa alat-alat optometri telah memenuhi Peraturan Uni Eropa tentang Alat Kesehatan (MDR 2017\/745), sehingga menjamin keakuratan, keamanan, dan kepatuhan terhadap peraturan.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Perangkat optometri LINKEYE \u2014 termasuk refraktometer otomatis, pengukur lensa, dan foropter \u2014 telah bersertifikat CE untuk presisi, keamanan, dan kinerja klinis yang andal, sehingga mendukung layanan perawatan mata yang terpercaya di seluruh dunia.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Tabel Oftalmologi CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Sertifikasi CE menegaskan bahwa alat-alat optometri dan meja pemeriksaan mata telah memenuhi standar keselamatan mesin dan kelistrikan Uni Eropa, sehingga menjamin pengoperasian yang stabil dan aman di klinik.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Meja Oftalmik LINKEYE \u2014 yang terdiri dari meja bermotor, unit refraksi, dan kursi \u2014 telah bersertifikat CE untuk keamanan mekanis, ketahanan, dan kinerja yang andal, sehingga memberikan keyakinan kepada para profesional dalam penggunaannya sehari-hari di klinik.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Refraktometer CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Sertifikasi CE menegaskan bahwa refraktometer telah memenuhi persyaratan Peraturan Uni Eropa tentang Alat Kesehatan (MDR 2017\/745), sehingga menjamin keamanan, akurasi, dan kepatuhan terhadap peraturan untuk penggunaan klinis.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Refraktometer Otomatis LINKEYE telah bersertifikat CE, yang menjamin pengukuran yang akurat, pengoperasian yang aman, dan kinerja yang andal. <\/p>\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tUnduhan <\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\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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Bagan Penglihatan LCD CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Sertifikasi CE menjamin bahwa Bagan Penglihatan LCD memenuhi persyaratan Peraturan Perangkat Medis Uni Eropa (MDR 2017\/745), sehingga menjamin pengujian penglihatan yang aman, andal, dan akurat di lingkungan klinis.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Bagan Penglihatan LCD dari LINKEYE telah bersertifikat CE, sehingga memungkinkan pengujian ketajaman penglihatan yang akurat, pengoperasian yang mudah, dan kinerja yang konsisten. <\/p>\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tUnduhan <\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\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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Pertanyaan Umum<\/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\/id\/sertifikasi\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CE, FDA, ISO Certification of Ophthalmic Equipment - LINKEYE\" \/>\n<meta property=\"og: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 property=\"og:url\" content=\"https:\/\/linkeyegroup.com\/id\/sertifikasi\/\" \/>\n<meta property=\"og:site_name\" content=\"LINKEYE\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-31T01:17:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/linkeyegroup.com\/wp-content\/uploads\/2025\/10\/FDA-Certificate-20240904-1.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"900\" \/>\n\t<meta property=\"og:image:height\" content=\"1273\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimasi waktu membaca\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 menit\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/linkeyegroup.com\\\/certification\\\/\",\"url\":\"https:\\\/\\\/linkeyegroup.com\\\/certification\\\/\",\"name\":\"CE, FDA, ISO Certification of Ophthalmic Equipment - 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