Getinge Disinfection Ab

FDA Filings

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

FDA Registration(s)

• Registration Number: 9616031
• FEI Number: 3000231474
• Name: GETINGE DISINFECTION AB
• Owner & Operator: Getinge Infection Control AB
• Contact Address: Ekebergsvagen 26 ; Getinge SE-NOTA 305 75 SE
• 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: LJUNGADALSGATAN 11 ; VAXJO Kronobergs lan [SE-07], 351 15 SE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07340153700086 Getinge Disinfection AB	GETINGE 46-SERIES 46-5-503	2019-04-12
GUDID 07340153700079 Getinge Disinfection AB	GETINGE 46-SERIES 46-5-502	2019-04-12
GUDID 07340153700062 Getinge Disinfection AB	GETINGE 46-SERIES 46-5-501	2019-04-12
GUDID 07340153700055 Getinge Disinfection AB	GETINGE 46-SERIES 46-5-500	2019-04-12
GUDID 07340153700048 Getinge Disinfection AB	GETINGE 46-SERIES 46-4-503	2019-04-12
GUDID 07340153700031 Getinge Disinfection AB	GETINGE 46-SERIES 46-4-502	2019-04-12
GUDID 07340153700024 Getinge Disinfection AB	GETINGE 46-SERIES 46-4-501	2019-04-12
GUDID 07340153700017 Getinge Disinfection AB	GETINGE 46-SERIES 46-4-500	2019-04-12
GUDID 07340153700277 Getinge Disinfection AB	GETINGE 86-SERIES S-86682003	2019-02-20
GUDID 07340153700253 Getinge Disinfection AB	GETINGE 86-SERIES S-86662003	2019-02-20
GUDID 07340153700260 Getinge Disinfection AB	GETINGE 86-SERIES S-86682001	2018-11-29
GUDID 07340153700246 Getinge Disinfection AB	GETINGE 86-SERIES S-86662001	2018-11-29
GUDID 07340153710276 Getinge Disinfection AB	Getinge 86-Series S-8668T1003	2018-10-01
GUDID 07340153710269 Getinge Disinfection AB	Getinge 86-Series S-8668T1001	2018-10-01
GUDID 07340153710320 Getinge Disinfection AB	Getinge 600-Series S-6080104	2018-03-29
GUDID 07340153710313 Getinge Disinfection AB	GETINGE 6000 SP6000GE003	2018-03-29
GUDID 07340153710306 Getinge Disinfection AB	GETINGE 6000 SP6000AR003	2018-03-29
GUDID 07340153710252 Getinge Disinfection AB	GETINGE 46-SERIES 46-5-402K977	2018-03-29
GUDID 07340153710245 Getinge Disinfection AB	GETINGE 600-SERIES S-6070104SE02	2018-03-29
GUDID 07340153710238 Getinge Disinfection AB	GETINGE 1800-SERIES FD1810-001K921	2018-03-29
GUDID 07340153710221 Getinge Disinfection AB	GETINGE 1800-SERIES FD1810-001K906	2018-03-29
GUDID 07340153710214 Getinge Disinfection AB	GETINGE 1800-SERIES FD1810-001	2018-03-29
GUDID 07340153710207 Getinge Disinfection AB	GETINGE 1800-SERIES FD1800K902IP24	2018-03-29
GUDID 07340153710191 Getinge Disinfection AB	GETINGE 1600-SERIES FD1600-001	2018-03-29
GUDID 07340153710160 Getinge Disinfection AB	GETINGE 46-SERIES 46-4-402K968	2018-03-29
GUDID 07340153710153 Getinge Disinfection AB	GETINGE CM320-SERIES CM320WDK966	2018-03-29
GUDID 07340153710146 Getinge Disinfection AB	GETINGE 46-SERIES 46-5-402K962	2018-03-29
GUDID 07340153710139 Getinge Disinfection AB	GETINGE 91-SERIES 9122-002K960	2018-03-29
GUDID 07340153710078 Getinge Disinfection AB	GETINGE 9100-SERIES 9128EW-001	2018-03-29
GUDID 07340153710061 Getinge Disinfection AB	GETINGE 9100-SERIES 9128E-001	2018-03-29
GUDID 07340153710054 Getinge Disinfection AB	GETINGE 9100-SERIES 9127E-001	2018-03-29
GUDID 07340153710047 Getinge Disinfection AB	GETINGE 9100-SERIES 9125E-001	2018-03-29
GUDID 07340153710030 Getinge Disinfection AB	GETINGE 9100-SERIES 9122EW-001	2018-03-29
GUDID 07340153710023 Getinge Disinfection AB	GETINGE 9100-SERIES 9120E-001	2018-03-29
GUDID 07340153700239 Getinge Disinfection AB	GETINGE WD 15 CLARO GE15-003	2018-03-29
GUDID 07340153700222 Getinge Disinfection AB	GETINGE WD 14 TABLO GE14-003	2018-03-29
GUDID 07340153700215 Getinge Disinfection AB	GETINGE CM320-SERIES CM320WWWD	2018-03-29
GUDID 07340153700208 Getinge Disinfection AB	GETINGE CM320-SERIES CM320WWD	2018-03-29
GUDID 07340153700192 Getinge Disinfection AB	GETINGE CM320-SERIES CM320WUWD	2018-03-29
GUDID 07340153700185 Getinge Disinfection AB	GETINGE CM320-SERIES CM320WU	2018-03-29
GUDID 07340153700178 Getinge Disinfection AB	GETINGE CM320-SERIES CM320WD	2018-03-29
GUDID 07340153700161 Getinge Disinfection AB	GETINGE 91-SERIES 9128-002	2018-03-29
GUDID 07340153700154 Getinge Disinfection AB	GETINGE 91-SERIES 9125-002	2018-03-29
GUDID 07340153700147 Getinge Disinfection AB	GETINGE 91-SERIES 9122-002	2018-03-29
GUDID 07340153700130 Getinge Disinfection AB	GETINGE 91-SERIES 9120-002	2018-03-29
GUDID 07340153700123 Getinge Disinfection AB	GETINGE 90-SERIES 9027-002	2018-03-29
GUDID 07340153700116 Getinge Disinfection AB	GETINGE 88-SERIES 88-323	2018-03-29
GUDID 07340153700109 Getinge Disinfection AB	GETINGE 88-SERIES 88-303	2018-03-29
GUDID 07340153700093 Getinge Disinfection AB	GETINGE 46-SERIES 46T-003	2018-03-29
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Models 9120E, 9122E, 9125E, 9127E, 9128E, 9128EW	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Models 9120, 9122, 9125, 9128	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Models 8666, 8668, S-8668T	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Models 46-2, 46-4, 46-4T, 46-5, 46-5T	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Model CM320	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Model 9027	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Model 88-5	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Getinge WD 14 Tablo	1993-11-10
MEC GETINGE DISINFECTION AB [Getinge Infection Control AB]	Getinge 15 Claro	1993-11-10

Related Finance Registrations

NCAGE Code	AV93N	GETINGE DISINFECTION AB
NCAGE Code	SZK33	GETINGE DISINFECTION AB
CAGE Code	AV93N	GETINGE DISINFECTION AB
CAGE Code	SZK33	GETINGE DISINFECTION AB

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081894330	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL DEVICES	19 PKG
2020081430153	Rotterdam,Netherlands -> Norfolk, Virginia	WASHER DISINFECTOR	2 PKG
2020081430307	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	11 PKG
20200811117483	Gothenburg,Sweden -> Norfolk, Virginia	MEDICAL DEVICES	6 PKG
2020081159870	Rotterdam,Netherlands -> Norfolk, Virginia	WASHER DISINFECTOR 9128E	2 PKG
2020080860360	Rotterdam,Netherlands -> Norfolk, Virginia	WASHER DISINFECTOR	2 PKG
2020080680775	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	WASH CART US 3 LEVELS 46-4	91 PKG
2020080680775	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	WASH CART US 3 LEVELS 46-4	91 PKG
2020080680775	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	WASH CART US 3 LEVELS 46-4	91 PKG
2020080444718	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	11 PKG