{"id":11043,"date":"2026-06-22T09:45:26","date_gmt":"2026-06-22T00:45:26","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=11043"},"modified":"2026-06-22T09:46:39","modified_gmt":"2026-06-22T00:46:39","slug":"drgem-wins-eu-ce-mdr-certification-for-raymo","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/id\/drgem-wins-eu-ce-mdr-certification-for-raymo\/","title":{"rendered":"DRGEM meraih Sertifikasi CE MDR Uni Eropa untuk RAYMO"},"content":{"rendered":"
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Memenuhi Standar Keselamatan dan Kualitas Eropa, Meletakkan Dasar untuk Ekspansi di Pasar X-ray Mobile Global<\/h2>\n\n\n\n

DRGEM (CEO J. B. Park), sebuah perusahaan solusi pencitraan medis global, mengumumkan bahwa sistem DR portabel generasi terbarunya, \u2018RAYMO\u2019, telah memperoleh sertifikasi CE MDR (Peraturan Alat Kesehatan) dari Uni Eropa. Pencapaian ini menyusul perolehan izin dari Badan Pengawas Obat dan Makanan AS (FDA) pada Mei lalu. Melalui tonggak sejarah ini, DRGEM akan melangkah melewati gerbang utama menuju pasar Eropa dan mempercepat ekspansi bisnis globalnya.<\/p>\n\n\n\n

Uni Eropa mewajibkan sertifikasi CE MDR untuk memastikan produk memenuhi standar keselamatan, kualitas, dan kinerja yang ketat. Sertifikasi ini merupakan persyaratan penting untuk menjual alat kesehatan di Wilayah Ekonomi Eropa (EEA) dan banyak negara lainnya. Dengan sertifikasi ini, DRGEM membangun landasan penjualan yang kokoh di Eropa dan memperkuat posisinya untuk memperluas jangkauan pelanggan dan kemitraan global<\/p>\n<\/div>\n\n\n\n

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DRGEM Mempercepat Pertumbuhan di Luar Negeri Berkat Jaringan Global di Lebih dari 130 Negara<\/h2>\n\n\n\n

RAYMO adalah sistem DR portabel terbaru dari DRGEM. Sistem ini mendukung pengambilan gambar yang cepat dan akurat di berbagai lingkungan klinis. Sistem ini dilengkapi dengan fungsi pengenalan pengguna berbasis RFID yang secara otomatis menerapkan pengaturan yang disesuaikan untuk setiap anggota staf medis. Selain itu, berbagai fungsi cerdas meningkatkan mobilitas dan kenyamanan pengguna guna meningkatkan efisiensi kerja.<\/p>\n\n\n\n

Permintaan global terhadap peralatan sinar-X portabel sedang tumbuh pesat. Di pasar ini, sertifikasi CE MDR menonjolkan keunggulan teknologi dan daya saing produk RAYMO. Memanfaatkan peluang ini, DRGEM berencana untuk memperkuat kegiatan pemasarannya di negara-negara besar di Eropa serta secara aktif memperluas kemitraan lokal.<\/p>\n\n\n\n

Sertifikasi ini lebih dari sekadar mengamankan kualifikasi penjualan; sertifikasi ini secara objektif memverifikasi keamanan, kualitas, dan keandalan produk. Oleh karena itu, perusahaan mengharapkan sertifikasi ini untuk meningkatkan adopsi oleh institusi medis dan mitra distribusi di luar negeri.<\/p>\n\n\n\n

J. B. Park, CEO DRGEM, mengatakan, \u201cMendapatkan sertifikasi CE MDR merupakan pengakuan resmi atas teknologi dan kualitas RAYMO yang berstandar global.\u201d Ia menambahkan, \u201cKami akan memperluas kemitraan global dengan fokus pada pasar Eropa dan semakin memperkuat posisi DRGEM di pasar sinar-X portabel.\u201d<\/p>\n\n\n\n

Sementara itu, DRGEM mengkhususkan diri dalam solusi diagnostik pencitraan radiografi digital. Perusahaan ini memperluas bisnisnya di luar negeri melalui jaringan penjualan dan mitra global di lebih dari 130 negara. Dengan memanfaatkan sertifikasi CE MDR yang dimiliki RAYMO sebagai momentum, perusahaan ini berencana untuk memasuki pasar Eropa secara penuh guna memastikan pertumbuhan berkelanjutan di tingkat global.<\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

Meeting European Safety and Quality Standards, Laying the Foundation for Expanding in the Global Mobile X-ray Market DRGEM (CEO J. B. Park), a global medical imaging solutions company, announced that its next-generation mobile DR system, \u2018RAYMO\u2019, has obtained the European Union’s CE MDR (Medical Device Regulation) certification. This achievement follows the acquisition of US FDA […]<\/p>\n","protected":false},"author":8,"featured_media":11047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14],"tags":[287,286,89,26,30,91,37,197,343,53],"class_list":["post-11043","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news","tag-ce-certification","tag-ce-certified","tag-digitalradiography","tag-drgem","tag-medicalimaging","tag-mobilexray","tag-radiography","tag-raymo","tag-raymo-ce","tag-xraysystems"],"yoast_head":"\nDRGEM wins EU CE MDR Certification for RAYMO - DRGEM<\/title>\n<meta name=\"description\" content=\"RAYMO CE certification marks a milestone for DRGEM. 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