NINGBO SHUN YE MEDICAL COMPANY, LTD.

FDA Device Registration & Listing · Cixi Ningbo Zhejiang, CN · Registration 3009103001

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009103001
FEI Number
3009103001
Entity Name
NINGBO SHUN YE MEDICAL COMPANY, LTD.
City/State/Country
Cixi Ningbo Zhejiang, CN
Establishment Address
#5 Industrial Road,, ZhangQi Industry Zone, Cixi Ningbo Zhejiang 315313, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ningbo Shun Ye Medical Company, Ltd. (Owner Number: 10037350)
Owner / Operator Contact Address
#5 Industrial Road,, ZhangQi Industry Zone, Cixi Ningbo, CN-ZJ 315313, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hi Temperature Cauteries Eye Bubble Bovie Medical Adjust Fine Tip Cauteries Change-A-Tip Cauteries Low-Temp Fine Cauteries Micro Temp Fine Bovie Medical Nerve Locator Bovie Change-A-Tip Cauteries Bovie Electrode Change-A-Tip cauteries Low Temeperatire Cauteries High Temperature Cauteries Electrosurgical Electrodes Symmetry Surgical Replacement Tips Low Temperature Cauteries

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 2017-02-03
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2023-04-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-07-07
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2017-02-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-03
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2017-02-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-03
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2025-05-19
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2011-07-12
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2022-12-08
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2012-07-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-03
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2024-04-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-01-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-03
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2017-02-03
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2014-10-16

Official Correspondent

Dingfeng Yu

US Agent Details

Christopher Smith Business: Aspen Surgical Products, Inc. Email: chris.smith@aspensurgical.com Phone: (888) 3647004

Related Public Records

Same Entity

Ningbo Shun Ye Medical Company, 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
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-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009103001. Last updated year: 2026. Please use registration number 3009103001 when referencing this establishment in official correspondence.
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