Sugentech, Inc.

Korea, Republic · Cheongju-si Chungcheongbuk-do · www.sugentech.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN KR-MF-000023952

This company has registrations in European Union, United States, Brazil, Canada, Taiwan, Singapore, Australia, 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

22UDI-DI device records

IVD A 8IVD B 5IVD general 9

USUnited StatesFDA openFDA

4listed device types

Class I 3Class II 1Class III 0

plus 4 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 3Class 2b 3Class 3 2

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 Union22 raw hits, 0 excluded, 22 confirmed

United States4 registration records, 1 510(k), 0 PMA

Manufacturer names merged into this page: SUGENTECH, INC. · SUGENTECH INC

Regulatory identity

EU manufacturer SRN: KR-MF-000023952
EU authorised representative: Medical Technology Promedt Consulting GmbH

Business registration

KRX ticker code: 253840
Registration status: Active
Incorporated: 2019-05-28

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

12016 · K142754

FDA listed device types

Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1Tube, Collection, Capillary Blood 1Kit, Test, Pregnancy, Hcg, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809408861327	—	IVD general
EU	08809408862966	—	IVD general
EU	08809408863185	—	IVD general
EU	08809408861341	—	IVD general
US	K142754	Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test	2016-04-07