Fresenius Hemocare G M B H

FDA Filings

This page includes the latest FDA filings for Fresenius Hemocare G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004634229
FEI Number3004634229
NameFRESENIUS HEMOCARE GMBH
Owner & OperatorFresenius Kabi AG
Contact Address-
61346 Bad Homburg DE-NOTA NONE DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGruener Weg 10
Friedberg Hessen, D-61169 DE
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
CATSmart2020-01-24
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
CATSmart2020-01-24
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
CATSmart System2016-09-22
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COMPOMAT G5 AND COMPOMASTER NET G5 SYSTEM2013-04-10
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COMPOCOOL2007-11-29
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COMPODOCK2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
HEMOLIGHT PLUS2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
DONATION MASTER NT2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COMPOGUARD2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COMPOMAT G42007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COMPOMASTER NT2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
HemoSeal2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
Composeal Universal2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
Composeal Mobilea2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
CompoSeal Mobilea II2007-11-16
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
P1R PLASMA TREATMENT SET2007-10-26
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
AS1042007-10-26
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
Waste bag 10 L2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
Reinfusion Bag with Y-Adapter2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
Reinfusion Bag 1000 mL2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
Fresenius CATS Autotransfusion Syst2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
ATF 40 Fast Start Kit2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
ATF 120 Fast Start Kit2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
AT1 Autotransfusion Set2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
TPE Plasma Exchange Set2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
COM.TEC CELL SEPARATOR2007-10-19
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
FRESENIUS CELL SEPARATION SYSTEM2005-09-14
FRESENIUS HEMOCARE GMBH [Fresenius Kabi AG]
FRESENIUS CATS AUT2005-09-14

Related Finance Registrations
NCAGE CodeC6619FRESENIUS HEMOCARE GMBH
CAGE CodeC6619FRESENIUS HEMOCARE GMBH
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009231109Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
202009192153Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
202009181824Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
202009113386Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
202009026570Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
202008289411Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
2020082216615Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
2020082027200Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES HS-CODE. 902790 HBL BANQBRE4379387 -----NOT STACKABLE-------- HS-CODE 902790 . .1 PKG
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