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AGS MEDTECH (THAILAND) CO., LTD.

Thailand · Pluak Daeng District Rayong

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

19listed device types

Class I 3Class II 16Class III 0

plus 33 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class II 14

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States33 registration records, 19 510(k), 0 PMA, 1 excluded

Brazil14 confirmed, 0 excluded

Manufacturer names merged into this page: AGS MEDTECH (THAILAND) CO., LTD. · Hangzhou AGS MedTech Co., Ltd. · HANGZHOU AGS MEDTECH CO., LTD · HANGZHOU AGS MEDTECH CO. , LTD. · HANGZHOU AGS MEDTECH CO., LTD.

FDA 510(k) clearances by year

22018

52020

22021

32022

22023

22025

32026

FDA listed device types

showing 8 of 19

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscope Channel Accessory 1Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1Forceps, Biopsy, Electric 1Endoscopic Irrigation/Suction System 1Dislodger, Stone, Biliary 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254069	Hemoclip (511 series, 543 series)	2026-08-10
US	K253393	Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019	2026-06-24
US	K252270	Hemoclip	2026-04-08
BR	10413969030	Injetor de Esclerose	Class II
BR	10413969008	CATETER BALÃO EXTRATOR	Class II
BR	10259759003	Pinça de Biópsia Descartável com Copas Articuladas HISTOBITETM	Class II

AGS MEDTECH (THAILAND) 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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