Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013927145

FEI Number

3013927145

Entity Name

HUIZHOU XINGHUAYUAN HOUSEWARE CO., LTD

City/State/Country

Huizhou City Guangdong, CN

Establishment Address

Tiechang Industrial District, Shiwan Town, Boluo County, Huizhou City Guangdong 516100, CN

Establishment Type(s)

Manufacture Medical Device,Remanufacture Medical Device,Sterilize Medical Device for Another Party (Contract Sterilizer),Reprocess Single-Use Device,Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device

Owner / Operator

Huizhou Xinghuayuan Houseware Co., LTD (Owner Number: 10056675)

Owner / Operator Contact Address

Tiechang Industrial District, Shiwan Town, Boluo County, Huizhou City, CN-GD 516100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Manual toothbrush, training toothbrush Ring,Teething,Non-fluid filled, Training teether Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-07-18
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2023-11-28
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2018-01-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Huizhou Xinghuayuan Houseware 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013927145. Last updated year: 2026. Please use registration number 3013927145 when referencing this establishment in official correspondence.