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i-SENS, Inc.

South Korea·KR-MF-000009173

Last updated September 17, 2026

Information

Country
South Korea
Address
43, Banpo-daero 28-gil, Seocho-gu, Seoul, South Korea
Website
i-sens.com/
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
855-646-3231
PRRC Contact
Jeong Hwa Lee
EUDAMED SRN
KR-MF-000009173
FDA FEI Number
3005621222
DUNS Number
688840958

Catalogue (108)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
CareSens S Fit BT 164509
FDA UDI
Class IIActive
CareSens N Voice 164442-202
FDA UDI
Class IIActive
KetoSens 276155
FDA UDI
Class IActive
CareSens N (MedPoint Diagnostics) 155104
FDA UDI
Class IIActive
KetoSens 276261-201
FDA UDI
Class IActive
CareSens N Voice Multi 164446-201
FDA UDI
Class IIActive
CareSens N 164104-203
FDA UDI
Class IIActive
CareSens N Voice Square 164502
FDA UDI
Class IIActive
CareSens N POP 164422
FDA UDI
Class IIActive
CareSens N Feliz 164507
FDA UDI
Class IIActive
Cool 521100
FDA UDI
Class IIActive
CareSens N 164301-202
FDA UDI
Class IIActive
CareSens N 164101
FDA UDI
Class IIActive
Greater Goods Essential 676
FDA UDI
Class IIActive
Tempo PGUHA-0000039
FDA UDI
Class IIActive
Fifty50 163604
FDA UDI
Class IIActive
VeraSens Voice 282442
FDA UDI
Class IIActive
CareSens N 164303-204
FDA UDI
Class IIActive
Greater Goods Essential 671
FDA UDI
Class IIActive
Cool 520010
FDA UDI
Class IIActive
CareSens II 164221
FDA UDI
Class IIActive
CareSens N 164303-203
FDA UDI
Class IIActive
CareSens N Multi 164104-204
FDA UDI
Class IIActive
Cool 520050
FDA UDI
Class IIActive
ReliOn Premier BLU Blood Glucose Monitoring System K230625
FDA 510(k)
Class IIActive
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System K201394
FDA 510(k)
Class IIActive
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System K170463
FDA 510(k)
Class IActive
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System K171480
FDA 510(k)
Class IIActive
Pc Care Blood Glucose Data Management Software K100937
FDA 510(k)
Class IIActive
Caresens Blood Glucose Monitoring System; Caresens Ii Meter, Model Gm505c; Caresens Pop Meter, Model Gm505ea Or Gm505eb K080923
FDA 510(k)
Class IIActive
Smartlog Diabetes Management Software K133346
FDA 510(k)
Class IIActive
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System K181273
FDA 510(k)
Class IIActive
KetoSens BT Blood B-Ketone Monitoring System K201551
FDA 510(k)
Class IActive
Assure Prism multi Blood Glucose Monitoring System K151164
FDA 510(k)
Class IIActive
Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution K103278
FDA 510(k)
Class IIActive
CareSens S Clear BT Blood Glucose Monitoring System K192859
FDA 510(k)
Class IIActive
ReliOn Premier Classic Blood Glucose Monitoring System K192220
FDA 510(k)
Class IIActive
NoCoding1 Plus Blood Glucose Monitoring System K160742
FDA 510(k)
Class IIActive
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System K170614
FDA 510(k)
Class IIActive
Caresens N Voice Blood Glucose Monitoring System K121133
FDA 510(k)
Class IIActive
LDE4 Lancing Device K222656
FDA 510(k)
Class IIActive
Acura Plus Multi Blood Glucose Monitoring System K131419
FDA 510(k)
Class IIActive
Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca K120351
FDA 510(k)
Class IIActive
Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model Gm5051a Or Gm5051b Or Gm5051c (color) K083468
FDA 510(k)
Class IIActive
Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control Solution K121654
FDA 510(k)
Class IIActive
Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood Glucose Meter K132288
FDA 510(k)
Class IIActive
CareSens S Fit BT Blood Glucose Monitoring System K193590
FDA 510(k)
Class IIActive
Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose Test Strip, Control Solution K120759
FDA 510(k)
Class IIActive
CareSens S Fit Blood Glucose Monitoring System K180866
FDA 510(k)
Class IIActive
Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution K103396
FDA 510(k)
Class IIActive

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