Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035434483

FEI Number

3035434483

Entity Name

AGS MEDTECH (THAILAND) CO., LTD.

City/State/Country

Pluak Daeng District Rayong, TH

Establishment Address

2F,7/ 582 moo 6 ,Map Yang Phon, Pluak Daeng District, Rayong, Thailand 21140, Pluak Daeng District Rayong 21140, TH

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Hangzhou AGS MedTech Co., Ltd. (Owner Number: 10052959)

Owner / Operator Contact Address

Building 2,5 and 7, No.389 Xingzhong Road, Linping District, Hangzhou, CN-ZJ 311103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252271

PMA Number

N/A

All Registered Proprietary Names

AGS AGS AGS AGS AGS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-12-19
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-03-08
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2023-05-10
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2016-10-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-05-10
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2018-07-02
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2025-11-30

Official Correspondent

Yanping Fu

US Agent Details

Hewu Ma Email: hewuma@hotmail.com Phone: (317) 4162074

Related Public Records

Same Entity

Hangzhou AGS MedTech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010288205	Hangzhou AGS MedTech Co., Ltd.	Hangzhou Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035434483. Last updated year: 2026. Please use registration number 3035434483 when referencing this establishment in official correspondence.