Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007382160

FEI Number

3007382160

Entity Name

i-SENS Wonju Factory

City/State/Country

Wonju-si Gangwon, KR

Establishment Address

94-1, Donghwagongdan-ro, Munmak-eup, Wonju-si Gangwon 26365, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

i-SENS, Inc. (Owner Number: 9083763)

Owner / Operator Contact Address

43, Banpo-daero 28-gil, Seocho-gu, Seoul, KR-11 06646, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120759

PMA Number

N/A

All Registered Proprietary Names

Lancet Greater goods lancet Tempo Lancet CareSens Lancet ReliOn Premier BLU Blood Glucose Monitoring System CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System NoCoding1 Plus Blood Glucose Monitoring System CareSens N Plus BT Blood Glucose Monitoring System tenovi Blood Glucose Monitoring System CareSens S Fit Blood Glucose Monitoring System CareSens Safety Lancet One Drop Blood Glucose Test Strip Assure Prism multi Blood Glucose Monitoring System GLUCOCARD Shine Control Solution GLUCOCARD Shine XL Blood Glucose Monitoring System CareSens N Blood Glucose Monitoring System CareSens N Feliz BT Blood Glucose Monitoring System CareSens N Feliz Blood Glucose Monitoring System CareSens N POP Blood Glucose Monitoring System GLUCOCARD Shine Blood Glucose Monitoting System Fifty 50 Blood Glucose Monitoring System 2 Sport Greater Goods Essential Blood Glucose Monitoring System LDE4 Lancing Device CareSoft Lancing Device Tempo Lancing Device KetoSens BT Blood ?-Ketone Monitoring System CareSens N Mini Blood Glucose Monitoring System ReliOn Premier COMPACT Blood Glucose Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-10-20
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-10-20
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-10-26
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-12-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-09-02
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-10-20
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-12-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-12-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-11-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-04-08
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-04-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2009-04-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2021-10-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-07-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-07-18
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-12-01
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-10-20
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-10-20
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2020-09-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-07-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-07-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-07-18

Official Correspondent

Han Wool Kim

US Agent Details

Yoon Ha Cha Business: i-SENS USA, Inc. Email: i-sens-usa@i-sens.com Phone: (607) 3771441

Related Public Records

Same Entity

i-SENS, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011213605	i-SENS Songdo Factory	Incheon, KR
3005621222	I-SENS, INC.	SEOUL, KR
3030186688	I-SENS Songdo Factory 2	lncheon Incheon, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

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3011806823	Roche Diabetes Care GmbH	Mannheim Baden-Wurttemberg, DE
1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US
3008789114	PRODIGY DIABETES CARE, LLC	Huntersville, NC, US
3007963752	BALDA MEDICAL GmbH	Bad Oeynhausen North Rhine-Westphalia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007382160. Last updated year: 2026. Please use registration number 3007382160 when referencing this establishment in official correspondence.