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CytoSorb® is CE-mark approved in the E.U. In the U.S., CytoSorb® and DrugSorb-ATR® are investigational devices not yet FDA authorized/approved/cleared.
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NON US HEALTHCARE PROFESSIONALS AREA
This section of the website contains medical and clinical information regarding products that are not cleared or approved by the U.S. Food and Drug Administration (FDA).  

Under U.S. federal law, including the Federal Food, Drug, dissemination of information about medical devices that are not FDA-cleared or approved for use in the United States may constitute unlawful promotion or misbranding if directed to U.S. healthcare professionals.

Accordingly:

This content is intended solely for Healthcare Professionals located outside the United States and Canada.

The products described are not approved or cleared in the United States or Canada for any indication.

Access by U.S. Healthcare Professionals is not permitted.

BY PROCEEDING, YOU CONFIRM THAT YOU ARE: A licensed Healthcare Professional, and located outside the United States and Canada.

Physician experience, clinical practice patterns, risks, and patient outcomes may vary. The information presented reflects individual clinical experience and does not constitute medical advice.

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