Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007748793

FEI Number

3007748793

Entity Name

BAISHENG MEDICAL CO.,LTD.

City/State/Country

JIANGMEN Guangdong, CN

Establishment Address

NO.11, FUSHENG ROAD, XINHUI DISTRICT, JIANGMEN Guangdong 529100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAISHENG MEDICAL CO., LTD (Owner Number: 10028995)

Owner / Operator Contact Address

No.11,Fusheng Road,XinHui District, JiangMen, CN-GD 529100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092634

PMA Number

N/A

All Registered Proprietary Names

Electrosurgical Pads Electrosurgical generator Disposable skin staplers Electrosurgical generator Electrosurgical Cutting and Coagulation Device and Accessories Electrocardiograph Electrode Electrosurgical Pencils

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-01-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-16
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2024-03-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-02-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-23
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-04-23
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-08-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-08

Official Correspondent

Chen Xi

US Agent Details

Vivi Lao Business: Fulwell LLC Email: register@fulwell.us.com Phone: (786) 2940983

Related Public Records

Same Entity

BAISHENG MEDICAL 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-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
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007748793. Last updated year: 2026. Please use registration number 3007748793 when referencing this establishment in official correspondence.