Getinge Ab

FDA Filings

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

SWEDEN

STOCKHOLM STOCK EXCHANGE

GETI B

DUNS 356751479

FDA Registration(s)

• Registration Number: 3013876692
• FEI Number: 3013876692
• Name: GETINGE USA SALES, LLC
• Owner & Operator: Getinge AB
• Contact Address: Lindholmspiren 7 ; Gothenburg SE-O Vastra Gotalands lan [SE-14] SE-417 56 SE
• Official Correspondent:
  • Dennis Genito
  • 46-10-3359015-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 45 BARBOUR POND DR ; Wayne, NJ 07470 US

• Registration Number: 3014766792
• FEI Number: 3014766792
• Name: Maquet Cardiopulmonary GmbH
• Owner & Operator: Getinge AB
• Contact Address: Lindholmspiren 7 ; Gothenburg SE-O Vastra Gotalands lan [SE-14] SE-417 56 SE
• Official Correspondent:
  • Dennis Genito
  • 46-10-3359015-x
• 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: Grabenstr. 25 ; Bodelshausen Baden-Wurttemberg, 72411 DE
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3012092534
• FEI Number: 3012092534
• Name: Getinge Group Logistics America, LLC
• Owner & Operator: Getinge AB
• Contact Address: Lindholmspiren 7 ; Gothenburg SE-O Vastra Gotalands lan [SE-14] SE-417 56 SE
• Official Correspondent:
  • Dennis Genito
  • 46-10-3359015-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 45 Barbour Pond Drive ; Wayne, NJ 07470 US

• Registration Number: 3007965489
• FEI Number: 3007965489
• Name: Datascope Corp
• Owner & Operator: Getinge AB
• Contact Address: Lindholmspiren 7 ; Gothenburg SE-O Vastra Gotalands lan [SE-14] SE-417 56 SE
• Official Correspondent:
  • Dennis Genito
  • 46-10-3359015-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 45 Barbour Pond Drive ; Wayne, NJ 07470 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K181122 | DSP Datascope Corp [Getinge AB]	Cardiosave	2019-11-25
KRI Maquet Cardiopulmonary GmbH [Getinge AB]	Maquet Cardiopulmonary Accessory	2018-09-06

Similar & Related FDA Registered Companies

• Getinge Infection Control AB
• Getinge Disinfection AB

Related Finance Registrations

NCAGE Code	AC74N	GETINGE AB
NCAGE Code	SH640	GETINGE AB
CAGE Code	SH640	GETINGE AB
CAGE Code	AC74N	GETINGE AB
SEC	0001719636	Getinge AB of SWEDEN
SEC	0001446738	Getinge AB of SWEDEN
SEC	0001451162	Getinge AB / ADR

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019020822810	Anvers,Belgium -> Norfolk, Virginia	STERILIZATION EQUIPMENT MRN 19SEE0DZSG0NM96OB5	4 PCS
2018100235832	Anvers,Belgium -> Norfolk, Virginia	STERILIZATION EQUIPMENT MRN 18SEECBCXF0ION07X6 . .	4 PCS