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News & Trends
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Main products “Portable organ (kidney) in vitro survival system” be recognized as Class ii medical devices by FDA
Publisher:admin  Date:2013-11-10 10:09:59  Click:1355

Recently, the US Food and Drug Administration (FDA) has affirmed that “Isolated kidney perfusion and transport system and accessories” shall belong to Class ii medical devices. As the main products are initiated in China, the Classification recognition of FDA provided important reference for State Food and Drug Administration.

This favorable news means a lot of registration cost of our products will be saved and the registration period will be greatly shortened.


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