FDA.reportPublic FDA data

NIPRO CORPORATION ODATE FACTORY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96109873002807710NIPRO CORPORATION ODATE FACTORY1N2026-01-018-7, Hanukiyachi, Niida ODATE-SHI Akita JP 018-5794

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105661713111404K960051NIPRO SAFELET CATHFOZ1996-03-28
105661156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
105662023620190K160444FB-U HemodialyzerKDI2017-02-08
105661411322168K140191ELISIO-H HEMODIALYZERKDI2014-04-14
105661739293837K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZERKDI2013-12-20
105661165739184
105661319420249
105661331721592
105661662386625
105661666648627
105661698693765

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI42019-07-19
FOZ11996-03-28