Development and production of blood glucose test strips, CGM systems, and Point-of-Care diagnostics
i-SENS, Inc.
Seoul (Seocho) · Songdo (Incheon) · Zhangjiagang · Eschborn · Torrance, CA · Gurgaon · Santiago · Kuala LumpurNew on Amplifa
About i-SENS
i-SENS, Inc. is a South Korean in-vitro diagnostics company founded in 2000, which develops and produces products based on electrochemical biosensor technology. The portfolio includes blood glucose monitoring systems (CareSens), the continuous glucose monitoring system CareSens Air – the first CGM developed in Korea with CE certification – and point-of-care analyzers for blood gas analysis, electrolytes, HbA1c, immunoassay, and coagulation. With an annual capacity of 2.1 billion blood glucose test strips, i-SENS supplies customers in over 110 countries and also offers OEM/ODM manufacturing and veterinary diagnostics. Main production takes place at the Songdo (Incheon, completed in 2023) and Zhangjiagang, China (i-SENS Jiangsu, since 2015) facilities. The product standard ISO 15197:2013 is cited for the CareSens systems. The company is listed on KOSDAQ; the parent company Precision Biosensor, Inc. is also listed. In Europe, the i-SENS GmbH, founded in 2016 and based in Eschborn, distributes the products.
- Site
- Eschborn
- Processes
- Manufacturing of blood glucose test strips, Electrochemical biosensor technology (Research, Development, Production), Manufacturing of Continuous Glucose Monitoring Systems (CGM), Manufacturing of Point-of-Care Diagnostics Systems (Blood Gas, Electrolyte, Immunoassay Analyzers), OEM/ODM Manufacturing, Research and Development, OEM/ODM Partnerships, Customer Service/Support
- Materials
- Electrochemical Biosensor Technology
- Certificates
- ISO 15197:2013 (CareSens Product Requirement), ISO 15197:2013 (CareSens Product Standard)
- Founded
- 2000
- Industries
- Medical Technology/In-vitro Diagnostics (IVD), Point-of-Care Diagnostics, Blood Glucose Self-Monitoring, Veterinary Medicine
- 01
Research and development of electrochemical biosensor technology
- 02
Production of test strips and meters (Songdo, Zhangjiagang)
- 03
Assembly of Point-of-Care analyzers and CGM systems
- 04
Quality control according to ISO 15197:2013
- 05
Distribution through subsidiaries and OEM/ODM partnerships
Technologies & Processes
Electrochemical Biosensor Technology
Core process for blood glucose test strips and CGM sensing used with whole blood.
Sites
Seoul (Seocho)
KRHeadquarters
Songdo (Incheon)
KRSecond Production Plant, completed in 2023
- Test Strip Factory
Zhangjiagang (Jiangsu)
CNi-SENS (Jiangsu) Co., Ltd. Production Plant, since 2015
Eschborn
DEi-SENS GmbH, European Distribution
Torrance, CA
USSubsidiary i-SENS USA, Inc.
Gurgaon
INSubsidiary i-SENS Biosensors India Pvt. Ltd.
Santiago
CLSubsidiary i-SENS Chile SpA.
Kuala Lumpur
MYSubsidiary i-SENS Biosensors Malaysia Sdn. Bhd.
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing of blood glucose test stripsAssembly | – | – | – | – | – |
| Electrochemical biosensor technology (Research, Development, Production)Engineering | – | – | – | – | – |
| Manufacturing of Continuous Glucose Monitoring Systems (CGM)Assembly | – | – | – | – | – |
| Manufacturing of Point-of-Care Diagnostics Systems (Blood Gas, Electrolyte, Immunoassay Analyzers)Assembly | – | – | – | – | – |
| OEM/ODM ManufacturingAssembly | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Production Plant (Test Strip Factory) | i-SENS | – | – | 2023 | Songdo, Korea |
| Production Plant | i-SENS | – | – | 2015 | China (i-SENS Jiangsu) |
Additional services
Quality
The CareSens blood glucose monitoring systems meet the accuracy, hematocrit, and interference criteria of the product standard ISO 15197:2013.
| Evidence | Songdo (Incheon) |
|---|---|
| ISO 15197:2013 (CareSens Product Standard) |
History
- 2000
Founding of i-SENS
- 2013
KOSDAQ Listing; Strategy for Globalization
- 2014
Founding of subsidiaries i-SENS Biz, Inc. and i-SENS (Jiangsu) Co., Ltd.; Relocation of headquarters to Seocho; Launch of A1Care (HbA1c) and i-Smart 300 (Blood Gas Analysis)
- 2015
China facility in Zhangjiagang completed; Subsidiaries in Chile and India; Launch of CareSens PRO, CareSens Dual and CareSens N Premier
- 2016
$70M Export Tower Award; Founding of i-SENS GmbH (Eschborn) and i-SENS Biosensors Malaysia; Acquisition of CoaguSense, Inc.; Launch of CareSens Expert Plus
- 2018
Market leader in Korea with 31% market share in blood glucose meters; Capacity over 1.6 billion test strips/year
- 2019
$100M Export Tower Award; Launch of i-SmartCare 10; World-Class Product Award
- 2020
Precision Biosensor, Inc. listed on KOSDAQ; Awarded as Innovative Medical Device Company
- 2022
Launch of ivisen IA-1100 Immunoassay Analyzer
- 2023
Acquisition of AgaMatrix, Inc.; Completion of second plant in Songdo; Launch of CareSens Air, the first CGM developed in Korea
- 2024
Market introduction of CareSens Air in Europe
- 2025
Launch of CareSens Air Receiver; 'My Health Phone' with Samsung; Upgrade CareSens Air Korea/EU
- 2026
15th consecutive First Brand Award for CareSens