i-SENS, Inc.

Korea, Republic · Seoul · www.i-sens.com

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 18 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

24registered device records

Class I 2Class IIb 3IVD A 2IVD B 1IVD C 6IVD general 8IVD Annex II List B 2

BRBrazilANVISA

7registered devices

Class II 7

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

7 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IVD Class 1 1IVD Class 2 1IVD Class 3 1IIb 2

HKHong KongMDACS

4valid listings

Class II 2IVD C 2

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 4Class 2b 6

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union4,204 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States18 registration records, 27 510(k), 0 PMA, 4 excluded

United Kingdom24 confirmed, 40 excluded

Brazil7 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: I-SENS, INC. · I- SENS, INC · I-SENS, INC · I-SENS

Regulatory identity

UK responsible person: MT Promedt Consulting Ltd

Business registration

KRX ticker code: 099190
Registration status: Active
Incorporated: 2013-01-30

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12008

12009

12010

22011

42012

42013

12015

12016

22017

32018

12019

32020

12021

12022

12023

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Glucose Oxidase, Glucose 1System, Test, Blood Glucose, Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62740	A1Care ACR Control Solution	IVD general
UK	62741	A1Care ACR Cartridge	IVD general
UK	61039	A1Care Analyzer	IVD general
US	K230625	ReliOn Premier BLU Blood Glucose Monitoring System	2023-08-10
US	K222656	LDE4 Lancing Device	2022-11-23
US	K201394	CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System	2021-10-05
BR	80117580526	Analisador A1Care	Class II
BR	80117580554	CareSens Lancet	Class II
BR	10300390285	CARTUCHO i-SMART 30 PRO - i-SENS	Class II
CA	93763	CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM	Class III