Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016168848

FEI Number

3016168848

Entity Name

Jiangsu Hope Biomedical Science&Technology Co.,Ltd.

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

Building 2, No. 88, Muyang Road, High-tech Industrial Development Zone, Yangzhou Jiangsu 225127, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Hope Biomedical Science&Technology Co.,Ltd. (Owner Number: 10089632)

Owner / Operator Contact Address

Building 2, No. 88, Muyang Road, High-tech Industrial Development Zone, Yangzhou, CN-JS 225127, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232703

PMA Number

N/A

All Registered Proprietary Names

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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	2023-12-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-03-18

Official Correspondent

Yinqing Liang

US Agent Details

Weian Huang Business: JOYSUN USA LLC Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

Jiangsu Hope Biomedical Science&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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016168848. Last updated year: 2026. Please use registration number 3016168848 when referencing this establishment in official correspondence.