5 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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KBL GmbH
FDA registration
KBL GmbH·2 products·🇩🇪 Germany
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KBL Sunlamp Products (= Device Bundling name)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025