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Rockwell Medical, Inc. Message Board

  • cheddaman45 cheddaman45 Jun 16, 2013 6:15 AM Flag

    CRMD .88 Ce mark by end of month

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    We have spoken to our lead regulator at TUV-SUD, the European Notified Body which is part of the regulatory CE Marking approval process in Europe, who informed us that our design dossier is complete. The committee that reviews the file for CE Mark approval is scheduled to review our file during the week of June 17, 2013 and is expected to render its decision before the end of June 2013. If granted, the CE Mark will enable us to commercialize Neutrolin in the European Union (EU).

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