FDA.reportPublic FDA data

Getinge 500 Series

Primary DI
05902533549511
Brand
Getinge 500 Series
Company
GETINGE IC PRODUCTION POLAND SP Z O O
Model
533HC
Catalog number
5SDUUPHTAAAA
Device description
STEAM STERILIZER HC - 533HC-E,L1,DD,460 VPS SST,DU,PWR,TRK,REC
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122071000GETINGE 400HC-E / SERIES STEAM STERILIZERGetinge Sourcing, LLC2013-03-12FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902533549511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902533549511059025335495115902533549511

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Regulatory Flags#

DUNS number
427370513
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902533549214Getinge 500 Series533HC5SSPUPHTABAA2026-02-16
05902533549115Getinge 500 Series533HC5SSVUPHRTATA2026-01-16
05902533549122Getinge 500 Series533HC5SSVUPHRA3AA2026-01-16
05902533548842Getinge 500 Series533HC5SSVUMHTAZAA2025-08-15
05902533548828Getinge 500 Series533HC5SSPUMHRTDAA2025-08-08
05902533548835Getinge 500 Series533HC5SDPUMHRTDAA2025-08-08
05902533548873Getinge 500 Series533HC5SDPUMHRTAAA2025-08-08
05902533549023Getinge 500 Series533HC5SSPUMHRTAAA2025-08-08
05902533548804Getinge 700 Series733HC7SRRUPHTAAAA2025-06-13
05902533548798Getinge 500 Series533HC5SDPRPHRAAAA2025-04-11
05902533548774Getinge 500 Series533HC5SSPUPHRABAA2025-03-14
05902533548781Getinge 500 Series533HC5SDPUPHRABAA2025-03-14
05902533548767Getinge 500 Series533HC5SSPUPHRAFAA2024-11-15
05902533548750Getinge 500 Series533HC5SSPUMHRALAA2024-09-13
05902533511792Getinge 800 Series833HC8SFPRTHPAAAA2021-08-13
05902533511808Getinge 800 Series833HC8SEPRTHPAAAA2021-08-13
05902533511761Getinge 800 Series833HC8SRPUTHPAAAA2021-07-09
05902533511778Getinge 800 Series833HC8SLPUTHPAAAA2021-07-09
05902533511716Getinge 800 Series833HC8MFPUGHPAAAA2021-02-12
05902533511693Getinge 800 Series833HC8SEVUTCPAAAA2021-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12
06972615108058icanclaveNingbo Ican Machines Co., Ltd.FLE2026-04-26
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07640397422288BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422295BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422301BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422318BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AGFLE2026-03-02
07629999900769Enbio PRO (ver. USA/CAN)Enbio Group AGFLE2026-03-02
05902533549214Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-02-16
00860014827310Lucas LifecareLucas Lifecare, LLCFLE2026-01-28
05902533549115Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
05902533549122Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
07640397421731STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421748STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421755STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421793STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664303EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664310EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-15
05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548835Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548873Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533549023Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
07640397421410STATIM 2000 G4 Cassette AutoclaveDent4You AGFLE2025-07-22