Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042158861

FEI Number

3042158861

Entity Name

PT MEDTECH TH CO., LTD

City/State/Country

PHRA NAKHON SI AYUTTHAYA, TH

Establishment Address

40/20-21 MOO.5, UTHAI SUB-DISTRICT, UTHAI DISTRICT, PHRA NAKHON SI AYUTTHAYA 13210, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Peter's Technology (Suzhou) Co., Ltd. (Owner Number: 10026729)

Owner / Operator Contact Address

No. 99 Jishi East Road, Wujiang District, Suzhou, CN-JS 215200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aveta Max+ Disposable Resecting Device, 3.9mm Aveta Auto 5 Fr Disposable Resecting Device Aveta Wave+ Disposable Resecting Tip, 3.9mm Aveta Flex+ Disposable Resecting Device, 2.9mm Aveta Flex Disposable Resecting Tip, 2.9mm Aveta Smol Disposable Resecting Tip, 2.9mm Aveta Auto Disposable Resecting Device Aveta Flex Disposable Resecting Device, 2.9mm Aveta Opal Disposable Hysteroscope, 4.6mm Aveta Disposable Resecting Handset Aveta Max Disposable Resecting Device, 3.9mm Aveta Fluid Management Accessory Aveta Waste Management Accessory Aveta Roll Stand With Drape Pump Aveta Drape Pump Aveta Smol Disposable Resecting Device, 2.9mm Aveta Wave+ Disposable Resecting Device, 3.9mm OMNI Surgical System OMNI Edge Surgical System Sion Surgical Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2020-11-11
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2020-11-11
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2023-10-18
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2023-10-18
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2022-07-03

Official Correspondent

Charlie Kuo

US Agent Details

Cary Kuo Email: caryjkuo@gmail.com Phone: (626) 2287665

Related Public Records

Same Entity

Peter's Technology (Suzhou) 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
3007113251	PETER'S TECHNOLOGY (SUZHOU) CO., LTD.	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
3033043422	NOVANTA MEDICAL S.R.O.	Prelouc Pardubicky Kraj, CZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042158861. Last updated year: 2026. Please use registration number 3042158861 when referencing this establishment in official correspondence.