Hinacom Receives CE Certification

In May 2018, Hinacom medical imaging software product received CE certification and is allowed to be sold in European Union countries and other countries that require such certification. The certification provides uniform technical specifications for the trade of products of various countries in the EU market, simplifies the trade procedures. Any product from any country must acquire CE certification before entering EU Market. 

CE Mark

Hinacom self-developed CE-approved products include 17 modules related to the integrated medical imaging platform and telemedicine platform covering 2D/3D PACS, specialty PACS for Ophthalmology and Dental imaging modalities, vascular vessel analysis, advanced 3D post-processing applications, artificial intelligence analysis of medical images, regional PACS, telemedicine, mobile PACS, and medical image sharing portal, all the cleared modules have been widely used in the integrated hospital medical platforms, regional/national medical imaging centers, telemedicine centers and other scenarios in China and other countries.

After a rigorous review by CE's authoritative certification institution, Hinacom obtained the EU Quality System Certificate and Product Certificate.

ISO13485 Certificate

Sotware Product Certificate

Hinacom has always attached importance to product certification. On the one hand, it promotes the continuous improvement of the company's quality management system, and on the other hand, it boosts the improvement of the function, quality, and scope of application of the product. Hinacom medical imaging software products not only obtained CE certification, but also obtained China CFDA certification and US FDA certification. Hinacom’s all-in-one hardware and software product - miEdge® series has acquired China CCC certification, US FCC certification and EU CE certification.

The acquisition of CE certification can not only enable products of Hinacom to enter the EU and other markets, but also accelerate the pace of Hinacom's promotion to the 'Belt and Road' nation market and provide strong support for the company to expand its international market.

Hinacom Profile

Hinacom Software and Technology, Ltd. is a healthcare IT company specializing in Medical Imaging/Telemedicine Systems and related applications. Headquartered in Beijing, Hinacom was founded in 2008 by veterans in healthcare IT and medical imaging with a combined 60+ years of industry experience. To demonstrate the core strength in R&D, the company has established 4 centers in Beijing, Tianjin, Zhengzhou, China and Minneapolis, US. Based on customer demand, Hinacom supports various flexible sales and business collaboration models. Its products have been successfully deployed in multiple hospitals/clinics in China, North America, Southeast Asia, South Asia, and MENA (Middle East and North Africa). Recognition has been widely received from worldwide experts and industry opinion leaders. Hinacom strives to become the global leading provider of Medical Imaging/Telemedicine products and services. The mission of the company is to enable quality healthcare for every person in the world.

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