I Sens Inc

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

099190

DUNS 688840958

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)

• Registration Number: 3015168139
• FEI Number: 3015168139
• Name: i-SENS Wonju Factory 2
• 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
  • i-sens-usa@i-sens.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 200, Gieopdosi-ro, Jijeong-myeon ; Wonju-si Gangweondo, 26354 KR
• Establishment Type: Repack or Relabel Medical Device

• Registration Number: 3005621222
• FEI Number: 3005621222
• Name: I-SENS, INC.
• 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: 43, Banpo-daero 28-gil, Seocho-gu ; SEOUL Seoul Teugbyeolsi, 06646 KR
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3014697030
• FEI Number: 3014697030
• Name: i-SENS, Inc.
• 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
  • i-SENS-USA@i-sens.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4th floor, 39-36, Nonhyeon-ro 46beon-gil, ; Namdong-gu Incheon Gwangyeogsiv, 21655 KR
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3007382160
• FEI Number: 3007382160
• Name: Jeonghan Ha
• 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: 2461 W. 205th St., Unit B102 ; Torrance, CA 90501 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 10885325001492 i-SENS, Inc.	KetoSens	2023-08-03
GUDID 10885325000853 i-SENS, Inc.	KetoSens	2023-08-03
GUDID 10885325001768 i-SENS, Inc.	CareSens N Voice Square	2023-07-19
GUDID 10885325001188 i-SENS, Inc.	CareSens S Fit BT	2023-07-19
GUDID 00885325001518 i-SENS, Inc.	CareSens S Fit	2023-07-19
PMN K222656 I-SENS, Inc.	LDE4 Lancing Device	2022-11-23
GUDID 10885325001690 i-SENS, Inc.	CareSens N Feliz	2022-07-26
GUDID 10885325001683 i-SENS, Inc.	CareSens N Feliz BT	2022-07-26
PMN K201394 I-SENS, Inc.	CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System	2021-10-05
GUDID 10885325001423 i-SENS, Inc.	Tempo	2021-02-25
GUDID 10885325001416 i-SENS, Inc.	Tempo	2021-02-25
GUDID 10885325001409 i-SENS, Inc.	Tempo	2021-02-25
GUDID 10885325001386 i-SENS, Inc.	Tempo	2021-02-25
PMN K201551 I-SENS, Inc.	KetoSens BT Blood B-Ketone Monitoring System	2020-09-09
PMN K192859 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	CareSens S Clear BT Blood Glucose Monitoring System	2020-01-25
PMN K192859 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens S Clear BT Blood Glucose Monitoring System	2020-01-25
PMN K192859 | NBW I-SENS, INC.	CareSens S Clear BT Blood Glucose Monitoring System	2020-01-25
PMN K192859 I-SENS, Inc.	CareSens S Clear BT Blood Glucose Monitoring System	2020-01-24
PMN K193590 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	CareSens S Fit BT Blood Glucose Monitoring System	2020-01-19
PMN K193590 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens S Fit BT Blood Glucose Monitoring System	2020-01-19
PMN K193590 | NBW I-SENS, INC.	CareSens S Fit BT Blood Glucose Monitoring System	2020-01-19
PMN K193590 I-SENS, Inc.	CareSens S Fit BT Blood Glucose Monitoring System	2020-01-17
PMN K192220 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2019-12-15
PMN K192220 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2019-12-15
PMN K192220 | NBW I-SENS, INC.	ReliOn Premier Classic Blood Glucose Monitoring System	2019-12-15
PMN K192220 I-SENS, Inc.	ReliOn Premier Classic Blood Glucose Monitoring System	2019-12-13
PMN K183255 | GJS i-SENS, Inc.	Coag-Sense Prothrombin Time (PT) / INR Monitoring Device	2019-03-11
PMN K181273 I-SENS, Inc.	GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	GLUCOCARD Shine Express Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	GLUCOCARD Shine Connex Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Express Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Connex Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW I-SENS, INC.	GLUCOCARD Shine Express Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW I-SENS, INC.	GLUCOCARD Shine Connex Blood Glucose Monitoring System	2018-11-01
PMN K180866 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens S Fit Blood Glucose Monitoring System	2018-09-02
PMN K180866 | NBW I-SENS, INC.	CareSens S Fit Blood Glucose Monitoring System	2018-09-02
PMN K180866 I-SENS, Inc.	CareSens S Fit Blood Glucose Monitoring System	2018-08-31
GUDID 20885325000812 i-SENS, Inc.	COOL	2018-07-06
GUDID 20885325000768 i-SENS, Inc.	COOL	2018-07-06
GUDID 20885325000751 i-SENS, Inc.	COOL	2018-07-06
GUDID 20885325000379 i-SENS, Inc.	COOL	2018-07-06
GUDID 20885325000027 i-SENS, Inc.	CareSens N	2018-07-06
GUDID 20857513006203 i-SENS, Inc.	VeraSens Voice	2018-07-06
GUDID 10885325000440 i-SENS, Inc.	CareSens N Voice	2018-07-06
GUDID 10885325000112 i-SENS, Inc.	CareSens N	2018-07-06
GUDID 10885325000051 i-SENS, Inc.	CareSens N (MedPoint Diagnostics)	2018-07-06
GUDID 10885325000044 i-SENS, Inc.	CareSens N (MedPoint Diagnostics)	2018-07-06
GUDID 10885325000013 i-SENS, Inc.	CareSens N	2018-07-06
GUDID 10857513006190 i-SENS, Inc.	VeraSens Voice	2018-07-06
PMN K170463 | JIN i-SENS Wonju Factory 2 [i-SENS, Inc.]	KetoSens Multi Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN i-SENS Wonju Factory 2 [i-SENS, Inc.]	KetoSens Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN Jeonghan Ha [i-SENS, Inc.]	KetoSens Multi Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN Jeonghan Ha [i-SENS, Inc.]	KetoSens Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN I-SENS, INC.	KetoSens Multi Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN I-SENS, INC.	KetoSens Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 I-SENS, Inc.	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System	2018-04-13
PMN K171480 I-SENS, Inc.	NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	NoCoding1 Plus Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	CareSens N Plus BT Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW Jeonghan Ha [i-SENS, Inc.]	NoCoding1 Plus Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Plus BT Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW I-SENS, INC.	VeraSens Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW I-SENS, INC.	NoCoding1 Plus Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW I-SENS, INC.	CareSens N Plus BT Blood Glucose Monitoring System	2017-12-13
PMN K170614 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier BLU Blood Glucose Monitoring System	2017-10-26
PMN K170614 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	2017-10-26
PMN K170614 | NBW I-SENS, INC.	ReliOn Premier BLU Blood Glucose Monitoring System	2017-10-26
PMN K170614 | NBW I-SENS, INC.	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	2017-10-26
PMN K170614 I-SENS, Inc.	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	2017-10-19
PMN K160742 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | NBW Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | NBW I-SENS, INC.	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | JJX i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | JJX Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | JJX I-SENS, INC.	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | CGA i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | CGA Jeonghan Ha [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | CGA I-SENS, INC.	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K161834 | NBW Jeonghan Ha [i-SENS, Inc.]	One Drop Blood Glucose Test Strip	2016-12-23
PMN K161834 | CGA Jeonghan Ha [i-SENS, Inc.]	One Drop Blood Glucose Test Strip	2016-12-23
PMN K160742 I-SENS, INC.	NoCoding1 Plus Blood Glucose Monitoring System	2016-12-16
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 K133346 | NBW I-SENS, INC.	SmartLog Diabetes Management Software	2016-05-09
PMN K133346 | JQP I-SENS, INC.	SmartLog Diabetes Management Software	2016-05-09
PMN K151164 | NBW Jeonghan Ha [i-SENS, Inc.]	Assure Prism multi Blood Glucose Monitoring System	2015-11-02
PMN K151164 | NBW I-SENS, INC.	Assure Prism multi Blood Glucose Monitoring System	2015-11-02
PMN K151164 I-Sens, Inc.	Assure Prism Multi Blood Glucose Monitoring System	2015-08-07
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
PMN K133346 I-SENS, Inc.	SMARTLOG DIABETES MANAGEMENT SOFTWARE	2013-12-19
PMN K121654 | NBW Jeonghan Ha [i-SENS, Inc.]	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | NBW I-SENS, INC.	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | JJX Jeonghan Ha [i-SENS, Inc.]	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | JJX I-SENS, INC.	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | CGA Jeonghan Ha [i-SENS, Inc.]	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K121654 | CGA I-SENS, INC.	SugaChek Blood Glucose Monitoring System	2013-12-04
PMN K132288 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | NBW I-SENS, INC.	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | JJX I-SENS, INC.	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 | CGA I-SENS, INC.	CareSens N Voice Multi Blood Glucose Monitoring System	2013-12-02
PMN K131419 | NBW Jeonghan Ha [i-SENS, Inc.]	ACURA PLUS Multi Blood Glucose Monitoring System	2013-12-02
PMN K131419 | NBW I-SENS, INC.	ACURA PLUS Multi Blood Glucose Monitoring System	2013-12-02
PMN K131419 | CGA Jeonghan Ha [i-SENS, Inc.]	ACURA PLUS Multi Blood Glucose Monitoring System	2013-12-02
PMN K131419 | CGA I-SENS, INC.	ACURA PLUS Multi Blood Glucose Monitoring System	2013-12-02
PMN K132288 I-SENS, Inc.	CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER	2013-11-22
FMK Jeonghan Ha [i-SENS, Inc.]	CareSens Sterile Lancets 30G	2013-09-03
FMK Jeonghan Ha [i-SENS, Inc.]	CareSens Sterile Lancets 28G	2013-09-03
FMK Jeonghan Ha [i-SENS, Inc.]	CareLance Lancing Device	2013-09-03
FMK I-SENS, INC.	CareSens Sterile Lancets 30G	2013-09-03
FMK I-SENS, INC.	CareSens Sterile Lancets 28G	2013-09-03
FMK I-SENS, INC.	CareLance Lancing Device	2013-09-03
PMN K130696 I-SENS, Inc.	CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM	2013-08-21
PMN K131419 I-SENS, Inc.	ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM	2013-08-09
PMN K121654 I-SENS, Inc.	AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION	2012-09-05
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW I-SENS, INC.	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW I-SENS, INC.	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW I-SENS, INC.	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | NBW I-SENS, INC.	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX I-SENS, INC.	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX I-SENS, INC.	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX I-SENS, INC.	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | JJX I-SENS, INC.	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA I-SENS, INC.	VeraSens Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA I-SENS, INC.	ReliOn Premier Voice Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA I-SENS, INC.	ReliOn Premier Classic Blood Glucose Monitoring System	2012-07-18
PMN K121133 | CGA I-SENS, INC.	CareSens N Voice Blood Glucose Monitoring System	2012-07-18
PMN K120759 | NBW Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | NBW I-SENS, INC.	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | NBW I-SENS, INC.	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | JJX Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | JJX I-SENS, INC.	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | JJX I-SENS, INC.	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | CGA Jeonghan Ha [i-SENS, Inc.]	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120759 | CGA I-SENS, INC.	ReliOn Premier COMPACT Blood Glucose Monitoring System	2012-07-18
PMN K120759 | CGA I-SENS, INC.	CareSens N Mini Blood Glucose Monitoring System	2012-07-18
PMN K120351 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Blood Glucose Monitoting System	2012-07-18
PMN K120351 | NBW Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0 Sport	2012-07-18
PMN K120351 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N POP Blood Glucose Monitoring System	2012-07-18
PMN K120351 | NBW I-SENS, INC.	GLUCOCARD Shine Blood Glucose Monitoting System	2012-07-18
PMN K120351 | NBW I-SENS, INC.	Fifty 50 Blood Glucose Monitoring System 2.0 Sport	2012-07-18
PMN K120351 | NBW I-SENS, INC.	CareSens N POP Blood Glucose Monitoring System	2012-07-18
PMN K120351 | CGA Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Blood Glucose Monitoting System	2012-07-18
PMN K120351 | CGA Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0 Sport	2012-07-18
PMN K120351 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N POP Blood Glucose Monitoring System	2012-07-18
PMN K120351 | CGA I-SENS, INC.	GLUCOCARD Shine Blood Glucose Monitoting System	2012-07-18
PMN K120351 | CGA I-SENS, INC.	Fifty 50 Blood Glucose Monitoring System 2.0 Sport	2012-07-18
PMN K120351 | CGA I-SENS, INC.	CareSens N POP Blood Glucose Monitoring System	2012-07-18
PMN K103396 | NBW Jeonghan Ha [i-SENS, Inc.]	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | NBW I-SENS, INC.	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | JJX Jeonghan Ha [i-SENS, Inc.]	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | JJX I-SENS, INC.	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | CGA Jeonghan Ha [i-SENS, Inc.]	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103396 | CGA I-SENS, INC.	COOL Blood Glucose Monitoring System	2012-07-18
PMN K103278 | NBW Jeonghan Ha [i-SENS, Inc.]	Assure Prism Control Solution	2012-07-18
PMN K103278 | NBW I-SENS, INC.	Assure Prism Control Solution	2012-07-18
PMN K103278 | JJX Jeonghan Ha [i-SENS, Inc.]	Assure Prism Control Solution	2012-07-18
PMN K103278 | JJX I-SENS, INC.	Assure Prism Control Solution	2012-07-18
PMN K103278 | CGA Jeonghan Ha [i-SENS, Inc.]	Assure Prism Control Solution	2012-07-18
PMN K103278 | CGA I-SENS, INC.	Assure Prism Control Solution	2012-07-18
PMN K100937 | NBW Jeonghan Ha [i-SENS, Inc.]	PC care Blood Glucose Data Management Software	2012-07-18
PMN K100937 | NBW I-SENS, INC.	PC care Blood Glucose Data Management Software	2012-07-18
PMN K100937 | JQP Jeonghan Ha [i-SENS, Inc.]	PC care Blood Glucose Data Management Software	2012-07-18
PMN K100937 | JQP I-SENS, INC.	PC care Blood Glucose Data Management Software	2012-07-18
PMN K121133 I-SENS, Inc.	CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM	2012-07-10
PMN K120759 I-SENS, Inc.	CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION	2012-06-05
PMN K120351 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
PMN K103278 I-SENS, Inc.	ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION	2011-10-28
PMN K103396 I-SENS, Inc.	COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION	2011-09-27
PMN K100937 I-SENS, Inc.	PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE	2010-12-21
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | NBW Jeonghan Ha [i-SENS, Inc.]	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | NBW I-SENS, INC.	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | NBW I-SENS, INC.	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | NBW I-SENS, INC.	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | NBW I-SENS, INC.	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | JJX Jeonghan Ha [i-SENS, Inc.]	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | JJX I-SENS, INC.	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | JJX I-SENS, INC.	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | JJX I-SENS, INC.	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | JJX I-SENS, INC.	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | CGA Jeonghan Ha [i-SENS, Inc.]	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K083468 | CGA I-SENS, INC.	GLUCOCARD Shine XL Blood Glucose Monitoring System	2009-04-08
PMN K083468 | CGA I-SENS, INC.	GLUCOCARD Shine Control Solution	2009-04-08
PMN K083468 | CGA I-SENS, INC.	Fifty 50 Blood Glucose Monitoring System 2.0	2009-04-08
PMN K083468 | CGA I-SENS, INC.	CareSens N Blood Glucose Monitoring System	2009-04-08
PMN K080923 | NBW Jeonghan Ha [i-SENS, Inc.]	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | NBW I-SENS, INC.	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | JJX Jeonghan Ha [i-SENS, Inc.]	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | JJX I-SENS, INC.	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | CGA Jeonghan Ha [i-SENS, Inc.]	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K080923 | CGA I-SENS, INC.	SmileCheker Blood Glucose Monitoring System	2009-04-08
PMN K083468 I-SENS, Inc.	CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)	2009-02-10
PMN K080923 I-SENS, Inc.	CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB	2008-10-17
PMN K052762 | NBW Jeonghan Ha [i-SENS, Inc.]	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | NBW I-SENS, INC.	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | JJX Jeonghan Ha [i-SENS, Inc.]	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | JJX I-SENS, INC.	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | CGA Jeonghan Ha [i-SENS, Inc.]	LIBERTY TEST STRIPS	2006-03-03
PMN K052762 | CGA I-SENS, INC.	LIBERTY TEST STRIPS	2006-03-03

Similar & Related FDA Registered Companies

• i-SENS USA, Inc.
• INTEGRATED SENSING SYSTEMS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092820771	Pusan,South Korea -> Boston, Massachusetts	TEST STRIP	32 PKG
2020092820771	Pusan,South Korea -> Boston, Massachusetts	TEST STRIP	32 PKG
2020092277675	Pusan,South Korea -> Long Beach, California	OTHER INSTRUMENTS AND APPARATUS	9 PKG
2020090344595	Pusan,South Korea -> Seattle, Washington	TEST STRIP	38 PKG
2020090344595	Pusan,South Korea -> Seattle, Washington	TEST STRIP	38 PKG
2020090329020	Pusan,South Korea -> Boston, Massachusetts	TEST STRIPS, BOXED,	27 PKG
2020090329020	Pusan,South Korea -> Boston, Massachusetts	TEST STRIP	27 PKG
2020090151883	Pusan,South Korea -> Seattle, Washington	TEST STRIP	38 PKG
2020090151883	Pusan,South Korea -> Seattle, Washington	TEST STRIP	38 PKG
2020082160180	Pusan,South Korea -> Long Beach, California	OTHER INSTRUMENTS AND APPARATUS	7 PKG
2020080844525	Pusan,South Korea -> Tacoma, Washington	TEST STRIP	5 CTN
2020073146811	Pusan,South Korea -> Seattle, Washington	BLOOD GLUCOSE MONITORING SYSTEM	68 PKG
2020073146811	Pusan,South Korea -> Seattle, Washington	BLOOD GLUCOSE MONITORING SYSTEM	68 PKG
2020073146811	Pusan,South Korea -> Seattle, Washington	BLOOD GLUCOSE MONITORING SYSTEM	68 PKG
2020073146811	Pusan,South Korea -> Seattle, Washington	BLOOD GLUCOSE MONITORING SYSTEM	68 PKG