Monday, September 27, 2010 11:59:51 AM
"We are very pleased to have attained this key milestone. ISO 13485 certification confirms that our manufacturing and quality systems meet the same high standards required of other major US medical device companies selling into Europe. Of the possible options, Full Quality Systems certification is the most stringent and efficient route to CE Mark approval for CytoSorb™ and other future CytoSorbents products. When coupled with CE Mark approval, ISO 13485 certification will allow CytoSorbents to commercialize its products in the E.U. market and other countries that recognize the ISO 13485 and CE Mark standards."
Recent CTSO News
- CytoSorbents And Converge Biotech Announce Strategic Partnership to Expand Sepsis and Critical Care Treatment with CytoSorb in India • GlobeNewswire Inc. • 11/11/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/07/2024 09:10:58 PM
- CytoSorbents Reports Third Quarter 2024 Financial and Operational Results • GlobeNewswire Inc. • 11/07/2024 09:05:00 PM
- CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification • GlobeNewswire Inc. • 11/04/2024 12:00:00 PM
- FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review • GlobeNewswire Inc. • 10/22/2024 11:00:00 AM
- CytoSorbents to Report Third Quarter 2024 Operating and Financial Results • GlobeNewswire Inc. • 10/17/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/09/2024 01:00:46 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/09/2024 01:00:14 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/01/2024 09:25:15 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 10/01/2024 09:22:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/01/2024 12:06:10 PM
- CytoSorbents Submits DrugSorb-ATR Marketing Application to U.S. FDA to Reduce the Severity of Bleeding in Heart Bypass Surgery Patients on the Blood Thinner Ticagrelor and Provides Business Update • GlobeNewswire Inc. • 10/01/2024 11:00:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 10/01/2024 04:15:18 AM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/26/2024 09:05:05 PM
- CytoSorbents to Present at the H.C. Wainwright 26ᵗʰ Annual Global Investment Conference • GlobeNewswire Inc. • 08/27/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/20/2024 08:51:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/16/2024 10:58:42 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/16/2024 10:57:45 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/16/2024 09:28:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 09:12:04 PM
- CytoSorbents Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 08/16/2024 08:05:00 PM
- CytoSorbents Reports Second Quarter 2024 Financial and Operational Results • GlobeNewswire Inc. • 08/13/2024 08:19:55 PM
- CytoSorbents Appoints Peter J. Mariani Chief Financial Officer • GlobeNewswire Inc. • 08/13/2024 08:18:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 08:04:32 PM
- CytoSorbents to Report Second Quarter 2024 Operating and Financial Results • GlobeNewswire Inc. • 08/07/2024 11:00:00 AM
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