Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004634229

FEI Number

3004634229

Entity Name

FRESENIUS HEMOCARE GMBH

City/State/Country

Friedberg Hesse, DE

Establishment Address

Gruener Weg 10, Friedberg Hesse D-61169, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Fresenius Kabi AG (Owner Number: 9027285)

Owner / Operator Contact Address

Else-Kroner-Str. 1, 61352 Bad Homburg, DE-NOTA NONE, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192368

PMA Number

N/A

All Registered Proprietary Names

CATSmart System COMPODOCK COM.TEC CELL SEPARATOR TPE Plasma Exchange Set Composeal Universal Composeal Mobilea HemoSeal CompoSeal Mobilea II CompoMat G5 Plus and CompoMaster Net G5 Plus AT1 Autotransfusion Set Waste bag 10 L Reinfusion Bag with Y-Adapter ATF 40 Fast Start Kit Reinfusion Bag 1000 mL ATF 120 Fast Start Kit Fresenius CATS Autotransfusion Syst COMPOMAT G5 AND COMPOMASTER NET G5 SYSTEM CATSmart CATSmart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2016-09-22
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2007-11-16
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2007-10-19
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Hematology	Class 2	864.6400	2007-11-16
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2020-07-01
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2007-10-19
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2013-04-10
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2020-01-24
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2020-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

Rhoda Lynn Valera Email: rhoda.valera@fresenius-kabi.com Phone: (847) 5502929

Related Public Records

Same Entity

Fresenius Kabi AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014732157	Fresenius Kabi USA, LLC	North Andover, MA, US
9611902	Fenwal France S.A.S.	Lacs Indre, FR
9681819	FRESENIUS KABI DEUTSCHLAND GMBH	BAD HERSFELD Hesse, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL
3005778453	FRESENIUS KABI WARRENDALE	WARRENDALE, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30

Similar Registrations

Registration Number	Establishment Name	Location
9611109	LivaNova Deutschland GmbH	MUNCHEN Bavaria, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL
3007923088	Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, MY
9680841	SORIN GROUP ITALIA S.R.L	MIRANDOLA Modena, IT
3006654680	Miller Technical Services	Plymouth, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004634229. Last updated year: 2026. Please use registration number 3004634229 when referencing this establishment in official correspondence.