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Finemedix Co., Ltd.

Korea, Republic · Daegu Gwangyeogsi

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Israel, Russia — 5 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

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 2Class II 9Class III 0

plus 12 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 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.

United States12 registration records, 11 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: FINEMEDIX · FINEMEDIX CO., LTD.

FDA 510(k) clearances by year

22018

22019

12020

12021

12023

12024

22025

12026

FDA listed device types

showing 8 of 11

Ligator, Esophageal 1Biopsy Needle 1Endoscopic Injection Needle, Gastroenterology-Urology 1Forceps, Biopsy, Electric 1Endoscopic Irrigation/Suction System 1Snare, Flexible 1Ligator, Hemorrhoidal 1Hemostatic Metal Clip For The Gi Tract 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251478	ClearTip TBNA Type	2026-04-16
US	K250994	ClearTip FNA and FNB Types	2025-08-21
US	K242857	ClearHemograsper	2025-05-21
BR	10334780074	PONTEIRA PARA ENDOSCOPIO - CLEAR CAP	Class I
BR	10334789015	CLEAR TIP - AGULHA PARA BIOPSIA/ ASPIRAÇÃO - EUS	Class II
BR	10334789016	AGULHA DE ASPIRAÇÃO/BIÓPSIA - CLEAR TIP	Class II

Finemedix Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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