Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042158867

FEI Number

3042158867

Entity Name

TIANYI MEDICAL (THAILAND) CO., LTD.

City/State/Country

PLUAKDAENG DISTRICT Rayong, TH

Establishment Address

7/167 MOO 4, MAB YANG PHON SUB-DISTRICT, PLUAKDAENG DISTRICT Rayong 21140, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tianyi Medical (Thailand) Co., Ltd. (Owner Number: 10094306)

Owner / Operator Contact Address

7/167 MOO 4, MAB YANG PHON SUB-DISTRICT, PLUAKDAENG DISTRICT, TH-21 21140, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251442

PMA Number

N/A

All Registered Proprietary Names

Extracorporeal Blood Tubing Set TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2025-11-21

Official Correspondent

Henry Yan

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Tianyi Medical (Thailand) Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042158867. Last updated year: 2026. Please use registration number 3042158867 when referencing this establishment in official correspondence.