Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043066040

FEI Number

3043066040

Entity Name

Fujian Quanzhou UnionWin Trading Co.,Ltd

City/State/Country

Quanzhou Fujian, CN

Establishment Address

666-5 Yifeng Middle Road, Quangang District, Quanzhou Fujian 362800, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Fujian Quanzhou UnionWin Trading Co., Ltd. (Owner Number: 10094591)

Owner / Operator Contact Address

666-5 Yifeng Middle Road, Quangang District, Quanzhou, CN-FJ 362800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

InStride Xelero

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2025-12-09

Official Correspondent

Dan Werremeyer

US Agent Details

Dan Werremeyer Email: dan@instrideshoes.com Phone: (908) 3349219

Related Public Records

Same Entity

Fujian Quanzhou UnionWin Trading 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 3043066040. Last updated year: 2026. Please use registration number 3043066040 when referencing this establishment in official correspondence.