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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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Last updated: January 2026

Regulatory Status Overview CytoSorbents Products

In Europe:

CytoSorb 300: (EU-CE marked)

CytoSorb® is approved in the European Union, with distribution authorized in more than 75 countries around the world.

 

CytoSorb is indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin are present. CytoSorb is indicated for intraoperative use during cardiopulmonary bypass surgery for removal of the P2Y12 inhibitor ticagrelor and/or the factor Xa inhibitor rivaroxaban.

 

CytoSorb is not yet approved or cleared in the United States or Canada.

 

ECOS 300-CY:

ECOS is approved in the European Union for removal of harmful substances from ex-vivo perfusion solutions as part of an ex-vivo perfusion system.

Intended Use: ECOS 300-CY (ECOS) is a non-pyrogenic, sterile, single-use polymer-based adsorption system designed for the dialysis of ex-vivo organ perfusion solutions in the field of extracorporeal therapies. ECOS is intended to be used with ex-vivo organ perfusion systems (e.g. ex-vivo normothermic/ hypothermic machine perfusion). ECOS is not yet approved or cleared in the United States or Canada for any indication.

 

PuriFi:

PuriFi is approved in the European Union for hemoadsorption treatments by use of a CytoSorb adsorption cartridge capable of retaining specific molecules responsible for development of particular diseases directly from the blood. PuriFi is not yet approved or cleared in the United States or Canada for any indication.

 

DrugSorb-ATR:

DrugSorb-ATR is an Investigational Device and not yet approved or cleared in the United States or Canada for any indication. DrugSorb-ATR is not yet approved or cleared in the European Union for any indication.

 

HemoDefend:

HemoDefend is not yet approved or cleared in the United States or Canada for any indication. HemoDefend is not yet approved or cleared in the European Union for any indication.
 

Product IFUS and complete Risk Information
  • Refer to the product IFU’s for complete information on the warnings, precautions, and contraindications of each device.

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