Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017558212

FEI Number

3017558212

Entity Name

CHANGSHU WELLAND TEXTILES CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

NO.11 HUANZHEN SOUTH ROAD,RENYANG,ZHITANGTOWN,CHANGSHU.JIANGSU, Suzhou Jiangsu 215539, CN

Establishment Type(s)

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

Owner / Operator

CHANGSHU WELLAND TEXTILES CO.,LTD (Owner Number: 10086446)

Owner / Operator Contact Address

NO.11 HUANZHEN SOUTH ROAD,RENYANG,ZHITANGTOWN,CHANGSHU.JIANGSU, Suzhou, CN-JS 215539, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Underpads and Chairpads SHEET PAD&BIB&SHEET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2022-11-09
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-11-09
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-08-01

Official Correspondent

DU WEILIN

US Agent Details

ZHIGANG ZHANG Email: BONNY008@proton.me Phone: (302) 3985328

Related Public Records

Same Entity

CHANGSHU WELLAND TEXTILES 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 3017558212. Last updated year: 2026. Please use registration number 3017558212 when referencing this establishment in official correspondence.