Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010361165

FEI Number

3010361165

Entity Name

ZHEJIANG JINHUA HUATONG MEDICAL APPLIANCE CO., LTD.

City/State/Country

Jinhua Zhejiang, CN

Establishment Address

Unit 1-2, Building 4, No. 168 Kechang Street, Qiubin Street,Wucheng District, Jinhua Zhejiang 321016, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. (Owner Number: 10044444)

Owner / Operator Contact Address

Unit 1-2, Building 4, No. 168 Kechang Street, Qiubin Street,Wucheng District, Jinhua, CN-ZJ 321016, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K823670

PMA Number

N/A

All Registered Proprietary Names

Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2021-08-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-10-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-01-02

Official Correspondent

jiancong zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Zhejiang Jinhua Huatong Medical Appliance 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2013	Gynex Corporation	2	Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "*GYNEX* Electrode Handpiece, Foot Activated* Manufactured for GYNEX*" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
2183744	Isomedix Operations, Inc.	Minneapolis, MN, US
3005350457	Omni-Guide Holdings, Inc.	Billerica, MA, US
3004491689	ConMed Corporation	Greenwood Village, CO, US
3004519921	TRI-STATE DE MEXICO, S. DE R.L. DE C.V.	MEXICALI Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010361165. Last updated year: 2026. Please use registration number 3010361165 when referencing this establishment in official correspondence.