FDA.reportPublic FDA data

GETINGE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96160313000231474GETINGE DISINFECTION AB1N2026-01-01LJUNGADALSGATAN 11 VAXJO Kronoberg SE 352 46
30120688313012068831Getinge IC Production Poland sp. z o.o.1N2026-01-01Szkolna 30 Plewiska Wielkopolskie PL 62-064
30120925343025504317Getinge Group Logistics America, LLC1N2026-01-01160 Princeton Highstown Road E Windsor NJ US 08520
30138766923013876692GETINGE USA SALES, LLC1Y2026-01-0145 Barbour Pond Dr Wayne NJ US 07470
30315631413031563141GETINGE AB1N2026-01-01KOPANINA 30A POZNAN Wielkopolskie PL 60-105

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3290251113576497K982063ALM PRISMALIX (PRX) SURGICAL LIGHTFSY1998-09-22
1880761134362251K982063ALM PRISMALIX (PRX) SURGICAL LIGHTFSY1998-09-22
1880761216776754K970886HANAULUX BLUE 80 HOSPITALFSS1997-04-16
3290251407855551K970886HANAULUX BLUE 80 HOSPITALFSS1997-04-16
1880761169979020K954169HANAULUX BLUE 30 & 80FSY1996-02-01
3290252038442267K954169HANAULUX BLUE 30 & 80FSY1996-02-01
3290251307496221K932451HANAULUX 2005 SURGICAL LIGHTFTD1993-11-12
1880761581880457K932451HANAULUX 2005 SURGICAL LIGHTFTD1993-11-12
3290251088328290K895715HANAULUX(R) 2000FTD1989-10-13
1880761784625439K895715HANAULUX(R) 2000FTD1989-10-13
3290251502684132K214120GSS610N21 Series Steam SterilizerFLE2022-05-18
3290251190606639K201927Getinge GSS610N Series Steam SterilizerFLE2021-03-01
3290251988701246K172159Getinge GSS67N Series Steam SterilizerFLE2018-01-30
1880761221583953K153713Getinge Series Warming CabinetLHC2016-06-07
3290251535335681K153713Getinge Series Warming CabinetLHC2016-06-07
1880761297251069K130513VOLISTA 400; VOLISTA 600FTD2013-05-08
2110421351125244K130513VOLISTA 400; VOLISTA 600FTD2013-05-08
3290251442948379K130513VOLISTA 400; VOLISTA 600FTD2013-05-08
1880761042330642K122625GETINGE 800HC- SERIES STEAM STERILIZERFLE2013-05-22
3290251866379944K122625GETINGE 800HC- SERIES STEAM STERILIZERFLE2013-05-22
3290251049254273K122071GETINGE 400HC-E / SERIES STEAM STERILIZERFLE2013-03-12
1880761305480153K122071GETINGE 400HC-E / SERIES STEAM STERILIZERFLE2013-03-12
3290251171248734K120441GETINGE 700HC-E SERIES STEAM STERILIZERFLE2012-05-31
1880761761601450K120441GETINGE 700HC-E SERIES STEAM STERILIZERFLE2012-05-31
1880761269119449K113679LUCEA LED SURGICAL LIGHT SYSTEMNTN2012-01-12
3290251948851817K113679LUCEA LED SURGICAL LIGHT SYSTEMNTN2012-01-12
1880761245214786K070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZERFLE2007-04-05
3290251435792291K070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZERFLE2007-04-05
3290251420134894K070442POWERLED SURGICAL LIGHT SYSTEMFSY2007-03-16
1880761691639951K070442POWERLED SURGICAL LIGHT SYSTEMFSY2007-03-16
1880761582101882K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEMFSY2004-05-21
3290251969967079K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEMFSY2004-05-21
3290251601764390K040015MODIFICATION TO PRISMALIX SURGICAL LIGHTFSY2004-01-21
1880761878475020K040015MODIFICATION TO PRISMALIX SURGICAL LIGHTFSY2004-01-21
3290251838307281K030906AXCEL SURGICAL LIGHTFSY2003-04-23
1880761928689665K030906AXCEL SURGICAL LIGHTFSY2003-04-23
1880761287550577
1880761459540450
1880761804851741
1880761808877262
1880761850621589
1880761888285792
3290251001081102
1880761014295966
3290251035567704
3290251137889184
3290251175569426
3290251225287158
3290251234416560
3290251259401780
3290251270412959
3290251317043491
3290251365280634
3290251422992849
3290251504624766
3290251551090344
1884811580815467
1880761580815467
1880761613014692
3290251622987156
1880761673531273
3290251717505178
3290251719124614
3290251757162164
3290251767414259
1884811888285792
3290251954154348

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FSY122007-03-16
FLE112022-05-18
FTD72013-05-08
LHC22016-06-07
NTN22012-01-12
FSS21997-04-16

PMN#

GUDID#

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