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  • 1.  HDE device re-registration

    This message was posted by a user wishing to remain anonymous
    Posted 28-Aug-2018 08:39
    This message was posted by a user wishing to remain anonymous

    Anyone familiar the process of re-registering a device (combination device) previously granted Humanitarian Use Exemption?

    We are also looking at re-registration in Europe as well, where the HDE combination device was previously approved as a pharmaceutical.  What's the process for European re-registration?


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