2 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: China
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Blue Beacon Submucosal Injectable Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023