Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030234858

FEI Number

3030234858

Entity Name

Betters(Suzhou) Medical Co., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Fifth Floor, Building 7, Taicang Biological Port, 52 Yingang Road, Taicang Port Economic and Technological Development Zone, Suzhou, Suzhou Jiangsu 215412, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Betters(Suzhou) Medical Co., LTD (Owner Number: 10089332)

Owner / Operator Contact Address

Fifth Floor, Building 7, Taicang Biological Port, 52 Yingang Road, Taicang Port Economic and Technological Development Zone, Suzhou, Suzhou, CN-JS 215412, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232241

PMA Number

N/A

All Registered Proprietary Names

Microwave Ablation System Disposable Microwave Ablation Needle

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	2023-11-29
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-29

Official Correspondent

qingxiang Lv

US Agent Details

Juezhe Huang Email: erichuang@bairdmed.com Phone: (315) 5589293

Related Public Records

Same Entity

Betters(Suzhou) Medical 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030234858. Last updated year: 2026. Please use registration number 3030234858 when referencing this establishment in official correspondence.