Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000947648

FEI Number

3000947648

Entity Name

SUZHOU ENNOVA ELECTRONIC TECHNOLOGY CO LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

The 3rd Floor, Building 2#, No. 1875 Zhong Huayuan West Road, Yushan Town, Kunshan District, Suzhou Jiangsu 215300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Suzhou Ennova Electronic Technology Co Ltd (Owner Number: 10051270)

Owner / Operator Contact Address

The 3rd Floor, Building 2#, No. 1875 Zhong Huayuan West Road, Yushan Town, Kunshan District, Suzhou, CN-JS 215300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Self-adhesive Electrode Electrocardiograph electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-02-24
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2019-12-22

Official Correspondent

Jianguang Huang

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (920) 6019045

Related Public Records

Same Entity

Suzhou Ennova Electronic 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000947648. Last updated year: 2026. Please use registration number 3000947648 when referencing this establishment in official correspondence.