Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045005759

FEI Number

3045005759

Entity Name

NANJING DEVIN MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

Building 9, 3rd Floor, No. 86, Shuanggao Road, Economic Development Zone, Gaochun District, Nanjing Jiangsu 211300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nanjing Devin Medical Technology Co., Ltd. (Owner Number: 10095519)

Owner / Operator Contact Address

Building 9, 3rd Floor, No. 86, Shuanggao Road, Economic Development Zone, Gaochun District, Nanjing, CN-JS 211300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253771

PMA Number

N/A

All Registered Proprietary Names

Microwave Ablation Device Disposable Microwave Ablation Antenna

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2026-03-24
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2026-03-24

Official Correspondent

Debing Zhao

US Agent Details

Yixuan Qiu Email: qiuconsulting@gmail.com Phone: (732) 3220436

Related Public Records

Same Entity

Nanjing Devin Medical 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-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Similar Registrations

Registration Number	Establishment Name	Location
1000523114	AngioDynamics, Inc.	Marlborough, MA, US
3010933564	EMBLATION LIMITED	Stirling, GB
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
3008132398	Sterigenics UK Limited	Alfreton Derbyshire, GB
3022977243	Varian Medical Systems, Inc.	Shoreview, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3045005759. Last updated year: 2026. Please use registration number 3045005759 when referencing this establishment in official correspondence.