2015-04-11 10:10

UIH Awarded CE Certification for uMI 510 and uCT 510 to Fuel Global Expansion

Shanghai United Imaging Healthcare Co., Ltd.(UIH)announced today that it has received CE certification for two of its advanced medical imaging devices.

The two products, the uMI 510 and the uCT 510, were certified with CE mark on April 10, 2015 from TÜV Rheinland, a world-leading certification body, as they met the highest global standard in terms of safety, performance and environmental protection. The CE certification enables the company to pursue commercial activities in EU nations.

The uMI 510 is the world’s first 96-crystal-ring light-guide PET-CT featuring super high-definition image quality and high scanning speed. The uCT 510 is a 16-slice CT scanner with 3D isotropic resolution.

A total of three advanced medical devices developed by UIH, covering the company’s three major product lines of MI, MR and CT, has been awarded CE certification since September 11, 2014, when the uMR 560, an advanced 1.5T MR system, was the first among UIH’s products to be certified with CE mark.

"Three of UIH's products have already passed stringent EU testing and received CE certification, thanks to UIH's constant pursuit of excellence in product quality and its international strategy focused on the quality assurance system," said the Director of UIH Quality Management Department.

Under the vison “to be a world-class medical equipment provider”, UIH aims to fuel global expansion at the very beginning of the R&D stage of each product, she said. "We have established a unique quality assurance system that runs throughout the entire lifecycle of each product, thus providing our clients with safe, high-quality products and services,” said the director.

The CE mark is known as a "passport" for manufacturers to enter the European market. Products to be tagged with CE mark have to pass the conformity assessment procedures and meet the requirements of the applicable EC directives, and are therefore qualified to be sold in the European Economic Area.

The CE Mark imposes rigorous requirements on products for safety, risk analysis and environmental protection. The uMI 510 and uCT 510 passed a series of tests and risk assessments, in terms of product safety, electromagnetic compatibility and usability, which were carried out by senior experts from TÜV Rheinland before there were certified with the CE Mark.

uMI 510

uCT 510

UIH's uMI 510 is integrated with HYPER ILGTM Technology, High Precision Crystal, Zero-GapTM Detector Ring and HYPERTM Electronics Technology, providing a breakthrough in both clinical resolution and scanning speed. The uCT 510 is equipped with uDoseTM Intelligent mA Modulation Technology, which means the radiation dose can be significantly reduced with uncompromised image quality.

TÜV Rheinland Group is the largest government-approved certification body for product safety and quality in Germany. It has been established in Germany and Europe for 125 years, and is one of the most renowned and authoritative third-party inspection agencies worldwide.

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