Getinge

FDA Filings

This page includes the latest FDA filings for Getinge. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003263092
• FEI Number: 3003263092
• Name: Dennis Genito
• Owner & Operator: Getinge
• Contact Address: Hans-Riedl-Strasse 21 ; Feldkirchen DE-BY Bayern 85622 DE
• Official Correspondent:
  • Dennis Genito
  • 49-89-459914-0
• US Agent:
  • Dennis Genito
  • Maquet Cardiovascular
  • 973 7097515
  • 973 8071658
  • Dennis.genito@Getinge.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 45 Barbour Pond Dr ; Wayne, NJ 07470 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K171620 | KRB Dennis Genito [Getinge]	PiCCO Catheter	2018-02-22
PMN K172259 | DXG Dennis Genito [Getinge]	PulsioFlex Monitor	2018-01-25
PMN K172259 | DXG Dennis Genito [Getinge]	PiCCO Module	2018-01-25
PMN K172259 | DXG Dennis Genito [Getinge]	CeVOX Module	2018-01-25
PMN K150310 | ORT Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | NHQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | NHP Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | NHO Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | MSX Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | MLD Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | MLC Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | MHX Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | LKD Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | KRC Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | KRB Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | KOI Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | KLK Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | GWS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | FLL Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DXN Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DXG Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSP Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSK Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSJ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSI Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSH Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSF Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DSA Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DRW Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DRT Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DRS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DRQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DRJ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DRG Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DQA Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | DPS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | CCL Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | CCK Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | CBS Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | CBR Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | CBQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | BZQ Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K150310 | BZC Dennis Genito [Getinge]	PICCO Temperature Probe	2017-11-15
PMN K122121 | DXG Dennis Genito [Getinge]	Pulsioflex	2012-12-31
PMN K122121 | DXG Dennis Genito [Getinge]	Pulsioflex Monitoring System	2012-12-31
PMN K122121 | DXG Dennis Genito [Getinge]	Pulsioflex Monitoring System with PiCCO Module	2012-12-31
PMN K122121 | DXG Dennis Genito [Getinge]	PC4510	2012-12-31
PMN K122121 | DXG Dennis Genito [Getinge]	PC4000	2012-12-31
PMN K112448 | DXG Dennis Genito [Getinge]	Pulsioflex	2011-12-15
PMN K091786 | DXG Dennis Genito [Getinge]	PiCCO2 (8500), CEVOX OPTICAL MODULE (PC3015) AND ACCESSORIES	2011-08-23
PMN K780126 | DRE Dennis Genito [Getinge]	PiCCO Arterial Catheter Procedure K	2010-04-05
PMN K991886 | KRB Dennis Genito [Getinge]	Pulsion Pulsiocath	2007-12-06
PMN K991886 | KRB Dennis Genito [Getinge]	Pulsion Pulsiocath, PiCCO Monitorin	2007-12-06
PMN K991886 | KRB Dennis Genito [Getinge]	Pulsion PCCO Monitoring Kit (PV8103, PV8115, PV8115CVP)	2007-12-06
PMN K072735 | DXG Dennis Genito [Getinge]	Pulsion PiCCO-2, Model 8500	2007-12-06
PMN K072364 | KRB Dennis Genito [Getinge]	Pulsiocath Thermodilution Catheters	2007-12-06
PMN K060898 | DXG Dennis Genito [Getinge]	Pulsion PiCCO Plus, Model 8100	2007-12-06
PMN K020587 | KRB Dennis Genito [Getinge]	Injectate Sensor Temperature Housing PV4046	2007-12-06
PMN K001762 | DXG Dennis Genito [Getinge]	Continuous Pulse Contour Cardiac	2007-12-06

Similar & Related FDA Registered Companies

• Getinge AB
• Getinge Infection Control AB
• Getinge (Suzhou) Co., Ltd.
• GETINGE SOURCING, LLC
• GETINGE USA, INC
• GETINGE/CASTLE, INC.
• GETINGE DISINFECTION, INC.
• GETINGE INTERNATIONAL, INC.
• Getinge Disinfection AB
• GETINGE IC PRODUCTION POLAND SP Z O O

Related Finance Registrations

NCAGE Code	B7915	GETINGE
CAGE Code	B7915	GETINGE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092856913	Rotterdam,Netherlands -> New York, New York	FURNITURE FOR HUMAN MEDICINE OR SURGERY	22 PKG
2020092633021	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SHELF TROLLEYHS:901890	14 PKG
2020092665247	Rotterdam,Netherlands -> New York, New York	FURNITURE FOR HUMAN MEDICINE OR SURGERY	22 PKG
202009121413	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	4 PKG
2020091018704	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	STERILIZER PRINTER FOR MEDICAL EQUIPMENT HS:8 44332	1 PKG
2020090230562	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SHELF RACK HS:901890	10 PKG
2020090279585	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	19 PKG
2020081722806	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ACROBAT-I STABILIZER ZHS:901890	22 PKG