NanoEntek Inc.

Korea, Republic · Seoul · www.nanoentek.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN KR-MF-000021903

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Russia — 8 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

69UDI-DI device records

IVD A 19IVD general 49ivd-annex-ii-list-b 1

USUnited StatesFDA openFDA

17listed device types

Class I 9Class II 7Class III 0unclassified 1

plus 46 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

19registered device records

IVD A 3IVD general 15IVD Annex II List B 1

BRBrazilANVISA

6registered devices

Class I 1Class II 5

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

8active registrations

Class 2a 3Class 2b 4Class 3 1

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 Union69 raw hits, 0 excluded, 69 confirmed

United States46 registration records, 1 510(k), 0 PMA, 2 excluded

United Kingdom19 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

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

Regulatory identity

EU manufacturer SRN: KR-MF-000021903
EU authorised representative: Medical Technology Promedt Consulting GmbH
UK responsible person: MT Promedt Consulting Ltd

Business registration

KRX ticker code: 039860
Registration status: Active
Incorporated: 2000-08-16

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

12013 · K124056

FDA listed device types

showing 8 of 17

Counter, Differential Cell 1Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers 1Radioimmunoassay, Total Triiodothyronine 1Test, Residual, Wbc In Leukoreduced Blood 1Radioimmunoassay, Free Thyroxine 1Radioimmunoassay, Thyroid-Stimulating Hormone 1System, Test, Vitamin D 1Block, Heating 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809317540368	FREND Thyroid Duo	IVD general
EU	08809317540054	FREND PCT	IVD general
EU	08809317540962	FREND hsCRP	IVD general
EU	08809317540641	FREND D-Dimer	IVD general
UK	47352	FREND BNP	IVD general
UK	58768	FREND hsCRP	IVD general
UK	56974	ADAMII-CD34 Kit	IVD general
US	K124056	FREND PSA PLUS (REAGENT CARTRIDGE)	2013-05-29
BR	80102513645	FAMÍLIA SISTEMA FREND	Class II
BR	80102512991	Sistema AP FREND	Class I
BR	80102513564	ADAMII	Class II

NanoEntek Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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