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Sources: EU EUDAMED, US FDA
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Country: Germany
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Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
FDA Enforcement
Class II
·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016
KPM ORTHO GmbH
Importer
🇩🇪 Germany
ORTHO-REHA Neuhof GmbH
Importer
🇩🇪 Germany·17 Manufacturers
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices