I-SENS USA, INC.

Matched from indexed company URL: I-SENS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008780388	3008780388	I-SENS USA, INC.	1	Y	2026-01-01	3545 Lomita Blvd., Unit D Torrance CA US 90505
3030186688	3030186688	I-SENS Songdo Factory 2	1	N	2026-01-01	43-10, Incheon tower-daero 25beon-gil, Yeonsu-gu lncheon Incheon KR 22013
3014697030	3014697030	i-SENS, Inc.	1	N	2020-04-25	4th floor, 39-36, Nonhyeon-ro 46beon-gil, Namdong-gu Incheon Gwangyeogsiv KR 21655
3015168139	3015168139	i-SENS Wonju Factory 2	1	N	2020-04-25	200, Gieopdosi-ro, Jijeong-myeon Wonju-si Gangweondo KR 26354

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00885325000856	KetoSens - KetoSens B-Ketone Monitoring System with Lancets	1-800-429-5001	cs1@i-sens.com
00885325001495	KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)	1-800-429-5001	cs1@i-sens.com
10885325000853	KetoSens - KetoSens B-Ketone Monitoring System with Lancets	1-800-429-5001	cs1@i-sens.com
10885325001492	KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)	1-800-429-5001	cs1@i-sens.com

i-sens.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
321871	1941827549	K230625	ReliOn Premier BLU Blood Glucose Monitoring System	NBW	2023-08-10
321871	1327689454	K222034	RightLance Blood Lancing System	QRL	2022-09-07
124763	1224567074	K220475	Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)	QRL	2022-07-06
321871	1347231344	K220475	Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)	QRL	2022-07-06
321871	1077204661	K220370	Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)	FMK	2022-05-19
124763	1484562245	K210748	Well-life TM Pen Needles, Well-life TM Safety Pen Needles	FMI	2022-05-25
124763	1962510585	K201551	KetoSens BT Blood B-Ketone Monitoring System	JIN	2020-09-09
321871	2055667759	K201551	KetoSens BT Blood B-Ketone Monitoring System	JIN	2020-09-09
124763	1612191364	K201394	CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System	NBW	2021-10-05
321871	1935849326	K201394	CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System	NBW	2021-10-05
235060	1666374281	K193590	CareSens S Fit BT Blood Glucose Monitoring System	NBW	2020-01-17
321871	1666374281	K193590	CareSens S Fit BT Blood Glucose Monitoring System	NBW	2020-01-17
124763	2066412408	K193590	CareSens S Fit BT Blood Glucose Monitoring System	NBW	2020-01-17
124763	1744601807	K192859	CareSens S Clear BT Blood Glucose Monitoring System	NBW	2020-01-24
321871	1958585977	K192859	CareSens S Clear BT Blood Glucose Monitoring System	NBW	2020-01-24
235060	1958585977	K192859	CareSens S Clear BT Blood Glucose Monitoring System	NBW	2020-01-24
235060	1223114381	K192220	ReliOn Premier Classic Blood Glucose Monitoring System	NBW	2019-12-13
228005	1746346829	K183255	Coag-Sense Prothrombin Time (PT) / INR Monitoring Device	GJS	2019-02-21
235060	1312901126	K181273	GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System	NBW	2018-11-01
321871	1312901126	K181273	GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System	NBW	2018-11-01
321871	1046143557	K180866	CareSens S Fit Blood Glucose Monitoring System	NBW	2018-08-31
124763	1909770462	K180866	CareSens S Fit Blood Glucose Monitoring System	NBW	2018-08-31
124763	1351722652	K171480	NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System	NBW	2017-12-13
321871	1405973364	K171480	NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System	NBW	2017-12-13
235060	1405973364	K171480	NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System	NBW	2017-12-13
124763	1295518976	K170614	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	NBW	2017-10-19
321871	1558451959	K170614	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	NBW	2017-10-19
235060	1137510298	K170463	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System	JIN	2018-04-13
321871	1137510298	K170463	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System	JIN	2018-04-13
124763	1560173115	K170463	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System	JIN	2018-04-13
235060	1263965417	K160742	NoCoding1 Plus Blood Glucose Monitoring System	NBW	2016-12-16
124763	1992233399	K160742	NoCoding1 Plus Blood Glucose Monitoring System	NBW	2016-12-16
321871	1533561813	K151164	Assure Prism multi Blood Glucose Monitoring System	NBW	2015-08-07
321871	1530635007	K132288	CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER	NBW	2013-11-22
124763	1783466985	K131395	TRANSTEK BLOOD PRESSURE MONITOR	DXN	2013-06-19
321871	1108507182	K121133	CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM	NBW	2012-07-10
124763	1444707629	K121133	CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM	NBW	2012-07-10
321871	1731552469	K120759	CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION	CGA	2012-06-05
321871	1013263631	K120351	CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA	NBW	2012-05-03
124763	1268557870	K120351	CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA	NBW	2012-05-03
321871	1388743255	K083468	CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)	NBW	2009-02-10
124763	1620520919	K083468	CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)	NBW	2009-02-10
124763	1102003830
321871	1549059154
321871	1746346829

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NBW	29	2023-08-10
JIN	5	2020-09-09
QRL	3	2022-09-07
FMI	1	2022-05-25
FMK	1	2022-05-19
GJS	1	2019-02-21
DXN	1	2013-06-19
CGA	1	2012-06-05

PMN#

ReliOn Premier BLU Blood Glucose Monitoring System
2023-08-10
I-Sens, Inc.
LDE4 Lancing Device
2022-11-23
I-SENS, Inc.
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
2021-10-05
I-SENS, Inc.
KetoSens BT Blood B-Ketone Monitoring System
2020-09-09
I-SENS, Inc.
CareSens S Clear BT Blood Glucose Monitoring System
2020-01-24
I-SENS, Inc.
CareSens S Fit BT Blood Glucose Monitoring System
2020-01-17
I-SENS, Inc.
ReliOn Premier Classic Blood Glucose Monitoring System
2019-12-13
I-SENS, Inc.
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
2018-11-01
I-SENS, Inc.
CareSens S Fit Blood Glucose Monitoring System
2018-08-31
I-SENS, Inc.
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
2018-04-13
I-SENS, Inc.
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
2017-12-13
I-SENS, Inc.
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
2017-10-19
I-SENS, Inc.
NoCoding1 Plus Blood Glucose Monitoring System
2016-12-16
I-SENS, INC.
Assure Prism Multi Blood Glucose Monitoring System
2015-08-07
I-Sens, Inc.
SMARTLOG DIABETES MANAGEMENT SOFTWARE
2013-12-19
I-SENS, Inc.
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
2013-11-22
I-SENS, Inc.
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
2013-08-21
I-SENS, Inc.
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
2013-08-09
I-SENS, Inc.
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
2012-09-05
I-SENS, Inc.
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
2012-07-10
I-SENS, Inc.
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
2012-06-05
I-SENS, Inc.
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
2012-05-03
I-SENS, Inc.
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
2011-10-28
I-SENS, Inc.
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
2011-09-27
I-SENS, Inc.
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
2010-12-21
I-SENS, Inc.
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
2009-02-10
I-SENS, Inc.
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
2008-10-17
I-SENS, Inc.

GUDID#

KetoSens - KetoSens B-Ketone Monitoring System with Lancets
i-SENS, Inc.
2020-11-10
KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)
i-SENS, Inc.
2020-11-10
KetoSens - KetoSens B-Ketone Monitoring System with Lancets
i-SENS, Inc.
2020-11-10
KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)
i-SENS, Inc.
2020-11-10
CareSens S Fit BT - CareSens S Fit BT Blood Glucose Monitoring System
i-SENS, Inc.
2023-07-11
CareSens N Voice Square - CareSens N Voice Square Blood Glucose Monitoring System
i-SENS, Inc.
2023-07-11
CareSens S Fit BT - CareSens S Fit BT Blood Glucose Monitoring System
i-SENS, Inc.
2023-07-11
CareSens S Fit - CareSens S Fit Blood Glucose Monitoring System
i-SENS, Inc.
2023-07-11
CareSens N Voice Square - CareSens N Voice Square Blood Glucose Monitoring System
i-SENS, Inc.
2023-07-11
Tempo - Tempo Lancing Device
i-SENS, Inc.
2023-01-26
Tempo - Tempo lancet (100T/pack)
i-SENS, Inc.
2023-01-26
Tempo - Tempo lancet (50T/pack)
i-SENS, Inc.
2023-01-26
Greater Goods Essential - Greater Goods Essential Blood Glucose Test Strip
i-SENS, Inc.
2023-01-26
Greater Goods Essential - Greater Goods Essential Blood Glucose Monitoring System
i-SENS, Inc.
2023-01-26
CareSens - CareSens Lancet (100T/Pack)
i-SENS, Inc.
2023-01-26
CareSens - CareSens Lancet (50T/Pack)
i-SENS, Inc.
2023-01-26
CareSens - CareSens Lancet (300T/Pack)
i-SENS, Inc.
2023-01-26
CareSoft - CareSoft Lancing Device
i-SENS, Inc.
2023-01-26
CareSens N Feliz - CareSens N Feliz Blood Glucose Monitoring System
i-SENS, Inc.
2023-01-26
CareSens N - CareSens N Blood Glucose Test Strip
i-SENS, Inc.
2023-01-26
CareSens N - CareSens N Blood Glucose Test Strip
i-SENS, Inc.
2016-09-23
CareSens N Feliz BT - CareSens N Feliz BT Blood Glucose Monitoring System
i-SENS, Inc.
2022-07-18
CareSens N Feliz - CareSens N Feliz Blood Glucose Monitoring System
i-SENS, Inc.
2022-07-18
CareSens N Feliz BT - CareSens N Feliz BT Blood Glucose Monitoring System
i-SENS, Inc.
2022-07-18
CareSens N Feliz - CareSens N Feliz Blood Glucose Monitoring System
i-SENS, Inc.
2022-07-18
Tempo - Tempo Blood Glucose Monitoring System
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Monitoring System
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Test Strip
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Test Strip
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Monitoring System
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Monitoring System
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Test Strip
i-SENS, Inc.
2021-02-17
Tempo - Tempo Blood Glucose Test Strip
i-SENS, Inc.
2021-02-17
CareSens II - CareSens II Blood Glucose Monitoring System (Basic meter set)
i-SENS, Inc.
2020-11-11
CareSens N Plus BT - CareSens N Plus BT Blood Glucose Monitoring System
i-SENS, Inc.
2020-11-11
CareSens N POP - CareSens N POP Blood Glucose Monitoring System
i-SENS, Inc.
2020-11-10
CareSens N Multi - CareSens N Multi Blood Glucose Test Strip
i-SENS, Inc.
2020-11-10
CareSens N Voice Multi - CareSens N Voice Multi Blood Glucose Monitoring System
i-SENS, Inc.
2020-11-10
KetoSens - KetoSens B-Ketone Test Strip (individual foiled packs x 50)
i-SENS, Inc.
2020-11-10
KetoSens - KetoSens B-Ketone Test Strip (individual foiled packs x 10)
i-SENS, Inc.
2020-11-10

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