BEUDAMED
    6 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Germany ×

    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

    ML2-BPS

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Greiner GmbH·2 devices

    OHST Medizintechnik Aktiengesellschaft

    Importer
    🇩🇪 Germany·2 Manufacturers

    170770416

    Certificate
    MDD Annex II (excluding section 4)·KLS Martin GmbH + Co. KG·DQS Medizinprodukte GmbH·1 Basic UDI-DI

    MPS Medical Product Service GmbH

    Authorized representative
    🇩🇪 Germany·35 Manufacturers·1959 Devices

    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