Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008249897

FEI Number

3008249897

Entity Name

LE SHIN INTERNATIONAL CO., LTD.

City/State/Country

Kaohsiung,, TW

Establishment Address

No. 17, Lisin Road, Zuoying District, Kaohsiung, 81366, TW

Establishment Type(s)

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

Owner / Operator

LE SHIN International Co., Ltd. (Owner Number: 10031385)

Owner / Operator Contact Address

No. 17, Lisin Road, Zuoying District, Kaohsiung,, TW-KHH 81366, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Compression Stocking Hernia Belt Ankle Brace Knee Brace Protect Arm Sling

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2010-01-24
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2021-11-04
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-12-08
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-12-08
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2025-03-31

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

LE SHIN International 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 3008249897. Last updated year: 2026. Please use registration number 3008249897 when referencing this establishment in official correspondence.