FDA.reportPublic FDA data

PHILOSYS Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30148487013014848701PHILOSYS Co., Ltd.1N2020-04-25#3, 23, Jeongjail-ro, Bundang-gu Seongnam-si Gyeonggido KR 13486

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2214701911842683K151658Gmate Origin Blood Glucose Monitoring SystemNBW2015-12-01
2214701366999389K150299Gmate SMART Blood Glucose Monitoring SystemNBW2015-11-19
2214701836304136K141656GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEMNBW2015-10-02
2214701252349543K131230GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATIONNBW2014-08-04
2214701805225952K113636BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)CGA2013-03-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW42015-12-01
CGA12013-03-08