FDA.report

Steam sterilizer

Definition
A 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.
GUDID devices
1,147
Last updated
2026-04-01 16:43:26

Related Product Codes

CodeDeviceSpecialtyClassDevices
FLESterilizer, SteamGeneral Hospital21,130
LRJDisinfectant, Medical DevicesGeneral Hospital115
OUGMedical Device Data SystemGeneral Hospital11
PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.General, Plastic Surgery21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
07540196001786STATCLAVE G4 Chamber AutoclaveScican LtdG4-6211032019-08-13
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AG362026-03-02
07629999900769Enbio PRO (ver. USA/CAN)Enbio Group AGEnbio PRO (ver. USA/CAN)2026-03-02
05902533549214Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2026-02-16
00860014827310Lucas LifecareLucas Lifecare, LLCLifeUltra2026-01-28
05902533549115Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2026-01-16
05902533549122Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2026-01-16
07640397421731STATCLAVE G4 Chamber AutoclaveDent4You AGG4-6211032026-01-06
07640397421748STATCLAVE G4 Chamber AutoclaveDent4You AGG4-621103-R2026-01-06
07640397421755STATCLAVE G4 Chamber AutoclaveDent4You AGG4-621103-L2026-01-06
07640397421793STATCLAVE G4 Chamber AutoclaveDent4You AGG4-6223032026-01-06
06972615108003icanclaveNingbo Ican Machines Co., Ltd.2545D2025-12-19
06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.ACA52025-09-15
05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-08-15
05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-08-08
05902533548835Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-08-08
05902533548873Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-08-08
05902533549023Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-08-08
07640397421410STATIM 2000 G4 Cassette AutoclaveDent4You AGG4-1211012025-07-22
07640397421427STATIM 2000 G4 Cassette AutoclaveDent4You AGG4-121101-L2025-07-22
07640397421434STATIM 2000 G4 Cassette AutoclaveDent4You AGG4-121101-R2025-07-22
07640397421588STATIM 5000 G4 Cassette AutoclaveDent4You AGG4-2011032025-07-22
07640397421595STATIM 5000 G4 Cassette AutoclaveDent4You AGG4-201103-L2025-07-22
07640397421601STATIM 5000 G4 Cassette AutoclaveDent4You AGG4-201103-R2025-07-22
07640397421663STATIM 5000 G4 Cassette AutoclaveDent4You AGG4-2111032025-07-22
07640397421670STATIM 5000 G4 Cassette AutoclaveDent4You AGG4-211103-L2025-07-22
07640397421687STATIM 5000 G4 Cassette AutoclaveDent4You AGG4-211103-R2025-07-22
07640397422059BRAVO G4 Chamber AutoclaveDent4You AG7A6200302025-07-22
07640397422066BRAVO G4 Chamber AutoclaveDent4You AG7A6210302025-07-22
07640397422073BRAVO G4 Chamber AutoclaveDent4You AG7A6200102025-07-22
07640397422080BRAVO G4 Chamber AutoclaveDent4You AG7A6210102025-07-22
D178CLAVE16Flight Dental SystemsFlight Dental Systems USA Inc.Clave16+2025-07-18
D178CLAVE23Flight Dental SystemsFlight Dental Systems USA Inc.Clave23+2025-07-18
D178CLAVE28Flight Dental SystemsFlight Dental Systems USA Inc.Clave28+2025-07-18
D178CLAVE45Flight Dental SystemsFlight Dental Systems USA Inc.Clave45+2025-07-18
D178CLAVE8Flight Dental SystemsFlight Dental Systems USA Inc.Clave8+2025-07-18
05902533548804Getinge 700 SeriesGETINGE IC PRODUCTION POLAND SP Z O O733HC2025-06-13
05902533548798Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-04-11
E308199331000Lexa PLUS RIS-311W & H STERILIZATION SRLLexa PLUS RIS-3112022-09-05
E308199331010Lexa PLUS RIS-311W & H STERILIZATION SRLLexa PLUS RIS-3112022-09-05
E308199351110Lexa MINI RIS-305W & H STERILIZATION SRLLexa MINI RIS-3052023-07-31
E308199352110Lexa MINI RIS-305W & H STERILIZATION SRLLexa MINI RIS-3052023-07-31
E308199352120Lexa MINI RIS-305W & H STERILIZATION SRLLexa MINI RIS-3052024-03-11
E308199441100Lexa MINI RIS-303W & H STERILIZATION SRLLexa MINI RIS-3032023-07-31
E308199442100Lexa MINI RIS-303W & H STERILIZATION SRLLexa MINI RIS-3032023-07-31
E308199451100Lexa MINI RIS-305W & H STERILIZATION SRLLexa MINI RIS-3052023-07-31
E308199452100Lexa MINI RIS-305W & H STERILIZATION SRLLexa MINI RIS-3052023-07-31
05902533548774Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-03-14
05902533548781Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2025-03-14
06976301910710YingtaiChangsha Yingtai Instrument Co., LtdHB-65A2025-03-01
06976301910727YingtaiChangsha Yingtai Instrument Co., LtdHB-65B2025-03-01
06976301910734YingtaiChangsha Yingtai Instrument Co., LtdHB-65C2025-03-01
06976301910741YingtaiChangsha Yingtai Instrument Co., LtdHB-90A2025-03-01
06976301910758YingtaiChangsha Yingtai Instrument Co., LtdHB-90B2025-03-01
06976301910765YingtaiChangsha Yingtai Instrument Co., LtdHB-90C2025-03-01
06976301910772YingtaiChangsha Yingtai Instrument Co., LtdHB-115A2025-03-01
06976301910789YingtaiChangsha Yingtai Instrument Co., LtdHB-115B2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdHB-115C2025-03-01
05902533548767Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2024-11-15
06970614967416SHINVAShinva Medical Instrument Co., Ltd.MOST-T2024-10-31
H65857037950Henry ScheinHENRY SCHEIN, INC.57037952024-10-28
H65857037960Henry ScheinHENRY SCHEIN, INC.57037962024-10-28
05902533548750Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2024-09-13
05902533548743Getinge 400 SeriesGETINGE IC PRODUCTION POLAND SP Z O O433HC2024-08-09
H658199431400Henry ScheinHENRY SCHEIN, INC.57037962024-08-09
H658199434400Henry ScheinHENRY SCHEIN, INC.57037952024-08-09
00304040185643Henry ScheinHENRY SCHEIN, INC.57038222024-08-08
00304040185650Henry ScheinHENRY SCHEIN, INC.57038232024-08-08
00304040169834Maxima TurboHENRY SCHEIN, INC.57033622024-06-25
00841709120985MidmarkMIDMARK CORPORATIONM11-0502024-06-20
00841709120992MidmarkMIDMARK CORPORATIONM11-0512024-06-20
00841709121029MidmarkMIDMARK CORPORATIONM9-0502024-06-20
00850005738251PRIMUS Steam SterilizerPrimus Sterilizer Company, LLCPSS11-HA2024-05-15
00850005738268PRIMUS Steam SterilizerPrimus Sterilizer Company, LLCPSS11-HB2024-05-15
00304040185094Henry ScheinHENRY SCHEIN, INC.57037952024-04-15
00304040185100Henry ScheinHENRY SCHEIN, INC.57037962024-04-15
00304040185070Henry ScheinHENRY SCHEIN, INC.57037932024-04-12
07629999190788EnbioEnbio Group AGEnbio S Beauty2024-03-25
05902533548187Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O O533HC2024-03-22
E30819935212Lexa MINI RIS-305W & H STERILIZATION SRLLexa MINI RIS-3052024-03-11