BEUDAMED
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    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    FDA Enforcement
    Class II ·Ongoing·Icecure Medical Ltd·October 11, 2023

    CE 699509

    Certificate
    MDD Annex II (excluding section 4)·New NI Medical (2011) Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI