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Sources: EU EUDAMED, US FDA
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Country: France
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STEPHANIX
Manufacturer
🇫🇷 France
Stephanix
FDA registration
Stephanix·3 products·🇫🇷 France
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
FDA Enforcement
Class II
·Terminated·Stephanix·December 12, 2018
STEPHANIX
Importer
🇫🇷 France