Getinge Infection Control Ab

FDA Filings

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

FDA Registration(s)
Registration Number3012068831
FEI Number3012068831
NameGetinge IC Production Poland Sp. z.o.o.
Owner & OperatorGetinge Infection Control AB
Contact AddressEkebergsvagen 26
Getinge SE-NOTA 305 75 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSzkolna 30
Plewiska Wielkopolskie, 62-064 PL
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number9616031
FEI Number3000231474
NameGETINGE DISINFECTION AB
Owner & OperatorGetinge Infection Control AB
Contact AddressEkebergsvagen 26
Getinge SE-NOTA 305 75 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLJUNGADALSGATAN 11
VAXJO Kronobergs lan [SE-07], 351 15 SE
Establishment TypeManufacture Medical Device

Registration Number2028456
FEI Number1000125215
NameSteriTec Products Mfg., Co., Inc.
Owner & OperatorGetinge Infection Control AB
Contact AddressEkebergsvagen 26
Getinge SE-NOTA 305 75 SE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address74 INVERNESS DR E
Englewood, CO 80112 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Maquet PowerLED II Surgical Light2018-11-20
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Maquet Rolite PowerLED II2018-11-20
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
PRISMALIX2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Hanaulux Blue 80 Hosp2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Hanaulux Blue 30 802018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Hanaulux Blue 30 802018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Hanaulux 20052018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Hanaulux 20002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
VOLISTA ACCESS2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
VOLISTA 6002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
VOLISTA 4002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
TRIOP 6002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
STANDOP VOLISTA2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ROLITE VOLISTA ACCESS2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ROLITE FOR VOLISTA STANDOP2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
VOLISTA ACCESS2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
VOLISTA 6002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
VOLISTA 4002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
TRIOP 6002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
STANDOP VOLISTA2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ROLITE VOLISTA ACCESS2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ROLITE FOR VOLISTA STANDOP2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA LED2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 502018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 1002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA LED2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 502018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 1002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA LED2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 502018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 1002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Rolite Power LED2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
PowerLED 5002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
PowerLED 3002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
POWERLED2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
X'TEN (X10)2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
PRISMALIX w/ ENERGIX2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
AXCEL2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
POWERLED 3002018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA LED2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 402018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
LUCEA 102018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ORCHIS2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ORCHIDE2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
ORCHIDE 3D2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
SATELITE MEDIA HD2018-03-14
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
GSS67N Steam Sterilizer2018-01-31
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Models 5524, 5618, 5624 Warming Cabinet2016-06-14
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERI-PAK LF BOWIE-DICK TEST PACK2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERI-PAK BOWIE DICK TEST PACK2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
CROSS-CHECKS P2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC DISPOSABLE BIOLOGICAL TEST PACK2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Steam Integrator X22015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC INTEGRAPH2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC CROSS-CHECKS2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC DRY HEAT INDICATOR LABEL2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
CROSS-CHECKS EO GAS STERILIZATION MONITOR2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
CROSS-CHECKS2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Biological Test Pack with Instant Readout Integrator2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Smart Read Biological Test Pack with Instant Readout Integrator2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Green Card Pack Bowie-Dick Test2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Green Tape2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Smart Read Biological Test Pack with Instant Readout Integrator2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
SteriTec Emu-Graph 4 Emulator2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC CONTAINER CARD2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC EMU-GRAPH2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
Green Card Bowie-Dick Test Card2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
INTEGRAPH FLASH2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
CROSS-CHECKS DUAL,2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
CROSS-CHECKS LF,2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERILIZATION PROCESS INDICATOR TAPE2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
EO GAS STERILIZATION PROCESS INDICATOR TAPES2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STERITEC BLUE AUTOCLAVE TAPES2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
Steam Biological Test Pack w/ Integ2015-12-02
SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]
STEAM/EO RECORD CARD2015-12-02
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Getinge 800HC-E Series Steam Sterilizer2013-05-31
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Getinge 400HC-E/500HC-E Series Steam Sterilizer2013-04-04
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Model 733HC-E2012-07-11
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Model 6332007-10-05
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Models 9120E, 9122E, 9125E, 9127E, 9128E, 9128EW1993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Models 9120, 9122, 9125, 91281993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Models 8666, 8668, S-8668T1993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Models 46-2, 46-4, 46-4T, 46-5, 46-5T1993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Model CM3201993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Model 90271993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Model 88-51993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Getinge WD 14 Tablo1993-11-10
Getinge IC Production Poland Sp. z.o.o. [Getinge Infection Control AB]
Getinge 15 Claro1993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Models 9120E, 9122E, 9125E, 9127E, 9128E, 9128EW1993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Models 9120, 9122, 9125, 91281993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Models 8666, 8668, S-8668T1993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Models 46-2, 46-4, 46-4T, 46-5, 46-5T1993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Model CM3201993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Model 90271993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Model 88-51993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Getinge WD 14 Tablo1993-11-10
GETINGE DISINFECTION AB [Getinge Infection Control AB]
Getinge 15 Claro1993-11-10

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020042845547Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES: HS CODE 8422200073 PKG
2020041868468Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES: HS CODE 8422200073 PKG
2019081029957Anvers,Belgium -> Houston, TexasMEDICAL DEVICESHS CODE: 841920005 PKG
2019060451392Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICESHS CODE: 842220004 PKG
2019060451392Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICESHS CODE: 842220004 PKG
2019032215897Anvers,Belgium -> New York/Newark Area, Newark, New JerseySTERIZONE4 PKG
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, TexasSTERILIZER EQUIPMENT18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019030527700Southhampton,United Kingdom -> Galveston, Texas.18 UNT
2019022247449Anvers,Belgium -> New York/Newark Area, Newark, New JerseySTERIZONE4 PKG
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
2019021535714Zeebrugge,Belgium -> Galveston, TexasSTERILIZATION EQUIPMENT 0011317770 HS CODE 8419200010 UNT
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