Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027341447

FEI Number

3027341447

Entity Name

GUANGZHOU HUAJU INFORMATION TECHNOLOGY CO., LTD

City/State/Country

guangzhou Guangdong, CN

Establishment Address

Room A118, No. 2, Dongkeng Street, Dongping, Yongping Street, Baiyun District, guangzhou Guangdong 510440, CN

Establishment Type(s)

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

Owner / Operator

Guangzhou Huaju Information Technology Co., Ltd (Owner Number: 10087745)

Owner / Operator Contact Address

Room A118, No. 2, Dongkeng Street, Dongping, Yongping Street, Baiyun District, guangzhou, CN-GD 510440, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Toothbrush powered Oral irrigator ,dental oral irrigator ,irrigator oral , dental water jet ,water flosser , dental water flosser , Massage instruments cosmetic instrument reading glasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-04-03
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-04-03
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2023-04-03
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2023-04-03
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2023-04-03

Official Correspondent

dan zhou

US Agent Details

jimmy chen Business: UGK-LVM UNITED INC Email: 547538132@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

Guangzhou Huaju Information Technology 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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027341447. Last updated year: 2026. Please use registration number 3027341447 when referencing this establishment in official correspondence.