i-SENS, Inc.

Manufacturer

🇰🇷 South Korea·3 Basic UDI-DIs·4 Devices·10 Importers

I-SENS, INC.

FDA registration

I-SENS, INC.·5 products·🇰🇷 South Korea

emVia Lancing Device

Device

EU MDR · Eu Md Class 1 ·i-SENS, Inc.·On the market

i-Smart 30 PRO Electrolyte Analyzer

Device

EU IVDR · Eu Ivd Class A ·i-SENS, Inc.·On the market

CareSens Air Continuous Glucose Monitoring System

Device

EU MDR · Eu Md Class 2b ·i-SENS, Inc.·On the market·1 country

alphacheck professional Lancing Device

Device

EU MDR · Eu Md Class 1 ·i-SENS, Inc.·On the market

I-SENS USA, INC.

FDA registration

I-SENS USA, INC.·9 products·🇺🇸 United States

Fifty50

FDA UDI

i-SENS, Inc.·00892896000086·Fifty50 Blood Glucose Monitoring System 2.0

CareSens N

FDA UDI

i-SENS, Inc.·00885325001785·CareSens N Blood Glucose Test Strip

CareSens

FDA UDI

i-SENS, Inc.·00885325000924·CareSens Lancet (50T/Pack)

COOL

FDA UDI

i-SENS, Inc.·00885325000818·COOL Blood Glucose Test Strip

Fifty50 Sport

FDA UDI

i-SENS, Inc.·00892896000260·Fifty50 Sport Blood Glucose Monitoring System 2.0

Fifty50

FDA UDI

i-SENS, Inc.·00892896000093·Fifty50 Blood Glucose Test Strip

CareSens N (MedPoint Diagnostics)

FDA UDI

i-SENS, Inc.·00885325000054·CareSens N Blood Glucose Test Strip

CareSens N Voice Square

FDA UDI

i-SENS, Inc.·00885325001761·CareSens N Voice Square Blood Glucose Monitorin...

CareSens N Plus BT

FDA UDI

i-SENS, Inc.·00885325001372·CareSens N Plus BT Blood Glucose Monitoring System

KetoSens

FDA UDI

i-SENS, Inc.·00885325001198·KetoSens B-Ketone Test Strip (individual foiled...

Tempo

FDA UDI

i-SENS, Inc.·00810011730045·Tempo lancet (100T/pack)

KetoSens

FDA UDI

i-SENS, Inc.·00885325001068·KetoSens B-Ketone Test Strips (individually foi...

KetoSens

FDA UDI

i-SENS, Inc.·00885325001075·KetoSens B-Ketone Monitoring System with Test S...