FDA.reportPublic FDA data

i-SENS Wonju Factory 2

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151681393015168139i-SENS Wonju Factory 21N2020-04-25200, Gieopdosi-ro, Jijeong-myeon Wonju-si Gangweondo KR 26354

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2350601666374281K193590CareSens S Fit BT Blood Glucose Monitoring SystemNBW2020-01-17
2350601958585977K192859CareSens S Clear BT Blood Glucose Monitoring SystemNBW2020-01-24
2350601223114381K192220ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13
2350601312901126K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
2350601405973364K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
2350601137510298K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN2018-04-13
2350601263965417K160742NoCoding1 Plus Blood Glucose Monitoring SystemNBW2016-12-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW62020-01-24
JIN12018-04-13