Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038202587

FEI Number

3038202587

Entity Name

FOSHAN GEZHE TECHNOLOGY CO., LTD

City/State/Country

foshan Guangdong, CN

Establishment Address

201, Floor 2, Building 5, Qide industrial park, No.1, Xingye East Road, Shunjiang Community Industrial Park, B, foshan Guangdong 528000, CN

Establishment Type(s)

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

Owner / Operator

FOSHAN GEZHE TECHNOLOGY CO., LTD (Owner Number: 10093183)

Owner / Operator Contact Address

201, Floor 2, Building 5, Qide industrial park, No.1, Xingye East Road, Shunjiang Community Industrial Park, B, foshan, CN-GD 528000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultrasonic Braces Cleaner GZ-CS04 GZ-CS15 GZ-CS08 GZ-CS09 GZ-CS05 GZ-CS06 GZ-CS07 GZ-CS02 GZ-CS12 GZ-CS14 Cordless Ultrasonic Denture Cleaner Ultrasonic Denture Cleaner Cordless Ultrasonic Braces Cleaner GZ-CS16 Ultrasonic Cleaning Cup SII-PCN001 GZ-CS01 AC-P001 CX50 GZ-CS03 C50 GZ-CS13 Cordless Ultrasonic Retainer Cleaner GZ-CS11 Ultrasonic Cleaner GZ-CS10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-04-11

Official Correspondent

hailang zhang

US Agent Details

jimmy chen Email: 78819034@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

FOSHAN GEZHE TECHNOLOGY CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038202587. Last updated year: 2026. Please use registration number 3038202587 when referencing this establishment in official correspondence.