Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011228909

FEI Number

3011228909

Entity Name

CYTOSORBENTS, INC.

City/State/Country

Princeton, NJ, US

Establishment Address

305 College Road East, Princeton, NJ 08540, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Cytosorbents, Inc. (Owner Number: 10047457)

Owner / Operator Contact Address

305 College Road East, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polymer Based Adsorption System CytoSorb 300 mL Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	Class 2	876.5870	2014-09-10

Official Correspondent

Matthew Gilliland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cytosorbents, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011228909. Last updated year: 2026. Please use registration number 3011228909 when referencing this establishment in official correspondence.