FDA.reportPublic FDA data

STERIS Canada ULC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96803533004097451STERIS Canada ULC1N2026-01-01490 Boulevard Armand-Paris QUEBEC CA G1C 8A3

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2809141912387486K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08
2809141793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2809141585242975K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)MED2023-10-03
2809141195992534K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2023-03-28
2809141931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2809141618118842K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorNVE2022-09-30
2809141730977769K222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateMED2022-09-28
2809141300111885K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorNVE2022-08-25
2809141448440171K220361Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA2022-03-10
2809141505182030K211607SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateMED2021-09-07
2809141075709618K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateMED2021-05-12
2809141507661431K203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA2021-01-28
2809141728309645K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-DisinfectorNVE2020-12-01
2809141025640523K200989Reliance Endoscope Processing SystemNZA2020-05-14
2809141810712054K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorNVE2020-04-03
2809141762161137K192929SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2019-12-10
2809141673534027K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED2019-09-05
2809141856743876K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemMED2019-03-22
2809141107961553K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorNVE2019-08-21
2809141054680592K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED2019-01-31
2809141927436931K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB2018-12-14
2809141590452196K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED2018-04-04
2809141129258706K173256System 1 endo Liquid Chemical Sterilant Processing SystemMED2018-03-02
2809141115511414K170956SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED2017-09-22
2809141350374811K161683SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED2016-08-05
2809141970277053K131078SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMMED2013-07-05
2809141683473561K113520SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMMED2012-02-21
2809141100139566K102462SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMMED2010-09-21
2809141566258813K102244RELIANCE ENDOSCOPE PROCESSING SYSTEMNZA2010-12-03
2809141742112060K101409SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEMMED2010-08-02
2809141898531194K090036SYSTEM 1.5 STERILE PROCESSING SYSTEMMED2010-04-05
2809141137669829K040049THE RELIANCE ENDOSCOPE PROCESSING SYSTEMNZA2004-12-17
2809141221744171
2809141459484980
2809141774095284
2809141936542179

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MED192026-04-08
NZA72023-10-03
NVE52022-09-30
FEB12018-12-14