Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043479340

FEI Number

3043479340

Entity Name

TSWEN HOEI ENTERPRISE VIETNAM CO., LTD.

City/State/Country

Ho Chi Minh City, VN

Establishment Address

Lot B2A1-CN, NE4 Road, My Phuoc 3 Industrial Park, Chanh Phu Hoa Ward, Ho Chi Minh City 75913, VN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Tswen Hoei Enterprise Vietnam Co., Ltd. (Owner Number: 10095168)

Owner / Operator Contact Address

Lot B2A1-CN, NE4 Road, My Phuoc 3 Industrial Park, Chanh Phu Hoa Ward, Ho Chi Minh City, VN-SG 75913, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Manual Bed Tips and Pads, Cane, Crutch and Walker Mechanical Walker Medical Chair and Table Recreational Daily Activity Assist Devices Transfer Aid Cane Infusion Stand Crutch Surgical Apparel Accessory Non-Measuring Exerciser Hygiene Products

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2026-02-02
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2026-02-02
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2026-02-02
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2026-02-02
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2026-02-02
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2026-02-02
IPS	Cane	Physical Medicine	Class 1	890.3075	2026-02-02
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2026-02-02
IPR	Crutch	Physical Medicine	Class 1	890.3150	2026-02-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2026-02-02
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2026-02-02
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2026-02-02

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Tswen Hoei Enterprise Vietnam Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043479340. Last updated year: 2026. Please use registration number 3043479340 when referencing this establishment in official correspondence.