I Sens Songdo Factory

FDA Filings

This page includes the latest FDA filings for I Sens Songdo Factory. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3011213605
FEI Number	3011213605
Name	i-SENS Songdo Factory
Owner & Operator	i-SENS, Inc.
Contact Address	43, Banpo-daero 28-gil, Seocho-gu Seoul KR-11 Seoul Teugbyeolsi 06646 KR
Official Correspondent	Hyun Joon Oh 82-2-9166191-x
US Agent	Jeonghan Ha i-SENS USA, Inc. 310 3200254 310 3200251 i-sens-usa@i-sens.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	12, Harmony-ro 275beon-gil, Yeonsu-gu, Incheon Incheon Gwangyeogsiv, 22014 KR
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K142336 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD 01 SENSOR	2016-10-17
PMN K142336 \| CGA i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD 01 SENSOR	2016-10-17
PMN K092104 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	Assure Platinum Blood Glucose Test Strip	2016-10-17
PMN K092104 \| JJX i-SENS Songdo Factory [i-SENS, Inc.]	Assure Platinum Blood Glucose Test Strip	2016-10-17
PMN K092104 \| CGA i-SENS Songdo Factory [i-SENS, Inc.]	Assure Platinum Blood Glucose Test Strip	2016-10-17
PMN K091102 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	Relion Prime Blood Glucose Test Strip	2016-10-17
PMN K091102 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD Vital Blood Glucose Test Strip	2016-10-17
PMN K091102 \| JJX i-SENS Songdo Factory [i-SENS, Inc.]	Relion Prime Blood Glucose Test Strip	2016-10-17
PMN K091102 \| JJX i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD Vital Blood Glucose Test Strip	2016-10-17
PMN K091102 \| CGA i-SENS Songdo Factory [i-SENS, Inc.]	Relion Prime Blood Glucose Test Strip	2016-10-17
PMN K091102 \| CGA i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD Vital Blood Glucose Test Strip	2016-10-17
PMN K142035 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM	2014-09-22
PMN K142035 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM	2014-09-22
PMN K124021 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM	2014-07-09
PMN K124021 \| NBW i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM	2014-07-09
PMN K124021 \| CGA i-SENS Songdo Factory [i-SENS, Inc.]	RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM	2014-07-09
PMN K124021 \| CGA i-SENS Songdo Factory [i-SENS, Inc.]	GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM	2014-07-09

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019062461809	Pusan,South Korea -> Tacoma, Washington	TEST STRIP	18 PKG
2019053066570	Pusan,South Korea -> Long Beach, California	GLUCOCARD 01 SENSOR50SUSA RETAIL AI	2 PKG
2019050263254	Pusan,South Korea -> Long Beach, California	GLUCOCARD 01 SENSOR	3 PKG
2019032870869	Pusan,South Korea -> Long Beach, California	ASSURE PRISM MULTI STRIP 50TPACK	3 PKG
2019022727919	Pusan,South Korea -> Long Beach, California	GLUCOCARD 01 SENSOR50S USA RETAIL AI	3 PKG
2019022058897	Pusan,South Korea -> Long Beach, California	GLUCOCARD 01 SENSOR50S USA RETAIL AI	3 PKG
2019012945152	Pusan,South Korea -> Long Beach, California	GLUCOCARD 01 SENSOR50S USA RELION AI	18 PKG
2019010355987	Pusan,South Korea -> Long Beach, California	GLUCOCARD 01 SENSOR50S USA RELION AI	23 PKG