Philosys Co L T D

FDA Filings

This page includes the latest FDA filings for Philosys Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010172486
FEI Number3010172486
NamePriscilla Chung
Owner & OperatorPhilosys Co.. Ltd.
Contact Address28-5, Gwangwol-gil, Okgu-eup
Gunsan-si KR-45 Jeonrabugdo 54172 KR
Official Correspondent
  • In Hwan Choi
  • 82-2-5531421-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1150 ROOSEVELT, SUITE 200
Irvine, CA 92620 US
Establishment TypeManufacture Medical Device

Registration Number3014848701
FEI Number3014848701
NamePHILOSYS Co., Ltd.
Owner & OperatorPhilosys Co.. Ltd.
Contact Address28-5, Gwangwol-gil, Okgu-eup
Gunsan-si KR-45 Jeonrabugdo 54172 KR
Official Correspondent
  • In Hwan Choi
  • 82-2-5531421-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address#3, 23, Jeongjail-ro, Bundang-gu
Seongnam-si Gyeonggido, 13486 KR
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3015949778
FEI Number3015949778
NamePriscilla Chung
Owner & OperatorPhilosys Co.. Ltd.
Contact Address28-5, Gwangwol-gil, Okgu-eup
Gunsan-si KR-45 Jeonrabugdo 54172 KR
Official Correspondent
  • In Hwan Choi
  • 82-2-5531421-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1150 ROOSEVELT, SUITE 200
Irvine, CA 92620 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
PHILOSYS Co., Ltd
 Pip Control Solution High 2020-09-21
PHILOSYS Co., Ltd
 Pip Control Solution Normal 2020-09-21
PHILOSYS Co., Ltd
 Pip Control Solution Low 2020-09-21
PHILOSYS Co., Ltd
 Pip Blood Glucose Test Strips 2020-09-21
PHILOSYS Co., Ltd
 Pip Blood Glucose Monitoring System 2020-09-21
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Origin2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Origin2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Origin2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Origin2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Origin2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Origin2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Smart (Android)2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate STEPmini2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate STEPmini2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate STEPmini2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate STEPmini2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate STEPmini2017-01-13
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate STEPmini2017-01-13
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Smart (IOS)2014-08-05
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
Priscilla Chung [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
PHILOSYS Co., Ltd. [Philosys Co.. Ltd.]
Gmate Voice2013-03-19
PHILOSYS CO. LTD.
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)2013-03-08

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019022619363Pusan,South Korea -> Los Angeles, CaliforniaBLOOD GLUCOSE TESTING STRIP1 PKG
2019021257084Pusan,South Korea -> Los Angeles, CaliforniaBLOOD GLUCOSE TESTING STRIP1 PKG
2019020977679Pusan,South Korea -> Los Angeles, CaliforniaBLOOD GLUCOSE TESTING STRIP1 PKG
2019010762033Pusan,South Korea -> Los Angeles, California18 PKGS OF BLOOD GLUCOSE MONITORING SYSTEM TE ST STRIP18 PKG
2018121355678Pusan,South Korea -> Long Beach, California19 PKGS OF BLOOD GLUCOSE MONITORING SYSTEM TE ST STRIP19 PKG
2018110851312Pusan,South Korea -> Los Angeles, California17 PKGS OF BLOOD GLUCOSE MONITORING SYSTEM TE ST STRIP17 PKG
2018101657828Pusan,South Korea -> Long Beach, California17 PKGS OF BLOOD GLUCOSE MONITORING SYSTEM TE ST STRIP17 PKG
2018091857958Pusan,South Korea -> Long Beach, California20 PKGS OF BLOOD GLUCOSE MONITORING SYSTEM TE ST STRIP20 PKG
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