Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008197884

FEI Number

3008197884

Entity Name

GMDASZ MANUFACTURING CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room E1308, Xihaimingzhu Building, Taoyuan Road , Nanshan District, Shenzhen Guangdong 518052, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

GMDASZ Manufacturing Co., Ltd. (Owner Number: 10031210)

Owner / Operator Contact Address

Building #1, HMB 3rd Industrial Zone, Baoan District, Shenzhen, CN-GD 518126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092546

PMA Number

N/A

All Registered Proprietary Names

Adhesive Electrodes PGF Electrodes IF Electrodes TENS Electrodes EMS Electrodes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-08-16
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2010-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

GMDASZ Manufacturing 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

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008197884. Last updated year: 2026. Please use registration number 3008197884 when referencing this establishment in official correspondence.