Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004516804

FEI Number

3004516804

Entity Name

YANGZHOU XINHUA BRUSHES CO., LTD.

City/State/Country

YANGZHOU Jiangsu, CN

Establishment Address

NO.2 QIONGHUA ROAD,HANGJI TOWN, YANGZHOU Jiangsu 225111, CN

Establishment Type(s)

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

Owner / Operator

Yangzhou Xinhua Brushes CO., LTD. (Owner Number: 10026538)

Owner / Operator Contact Address

NO.2 QIONGHUA ROAD,HANGJI TOWN, YANGZHOU, CN-JS 225111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

glove TONGUE CLEANER Mask Dental Floss Dental Floss Pick frame,spectacle Face Shield eye protector TOOTHBRUSH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-03
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2021-11-17
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-03
JES	Floss, Dental	Dental	Class 1	872.6390	2011-11-17
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-03
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2008-07-29

Official Correspondent

Maggie Yin

US Agent Details

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

Related Public Records

Same Entity

Yangzhou Xinhua Brushes 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004516804. Last updated year: 2026. Please use registration number 3004516804 when referencing this establishment in official correspondence.