i-SENS Songdo Factory

FDA Device Registration & Listing · Incheon, KR · Registration 3011213605

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011213605
FEI Number
3011213605
Entity Name
i-SENS Songdo Factory
City/State/Country
Incheon, KR
Establishment Address
12, Harmony-ro 275beon-gil, Yeonsu-gu,, Incheon 22014, 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
N
Expiration Date (Year)
2026
510(k) Number
K121133
PMA Number
N/A

All Registered Proprietary Names

CareSens N Feliz BT Blood Glucose Monitoring System CareSens N Feliz Blood Glucose Monitoring System GLUCOCARD Shine Control Solution GLUCOCARD Shine XL Blood Glucose Monitoring System CareSens N Blood Glucose Monitoring System GLUCOCARD 01 SENSOR RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM NoCoding1 Plus Blood Glucose Monitoring System CareSens N Plus BT Blood Glucose Monitoring System tenovi Blood Glucose Monitoring System GLUCOCARD Shine Express Blood Glucose Monitoring System GLUCOCARD Shine Connex Blood Glucose Monitoring System CareSens N Voice Square Blood Glucose Monitoring System ReliOn Premier BLU Blood Glucose Monitoring System CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System ReliOn Premier Classic 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 Lancet Greater goods lancet Tempo Lancet CareSens Lancet CareSens N Voice Blood Glucose Monitoring System ReliOn Premier Voice Blood Glucose Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-10-14
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 2016-10-17
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2016-10-17
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-09-22
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 2018-11-01
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 2019-12-15
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 2022-10-20
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-10-20
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
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 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
3005621222 I-SENS, INC. SEOUL, KR
3030186688 I-SENS Songdo Factory 2 lncheon Incheon, KR
3007382160 i-SENS Wonju Factory Wonju-si Gangwon, 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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

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-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011213605. Last updated year: 2026. Please use registration number 3011213605 when referencing this establishment in official correspondence.
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