Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033919280

FEI Number

3033919280

Entity Name

DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Building 1, Room 201, No.397, Huancheng Road, Huangjiang Town, Dongguan Guangdong 523750, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan Goochain Technology Co., Ltd (Owner Number: 10091915)

Owner / Operator Contact Address

Building 1, Room 201, No.397, Huancheng Road, Huangjiang Town, Dongguan, CN-GD 523750, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CES Sleep Therapy Ear Clip ECG Lead Wire, EEG Electrode Connection Cable, Electrode Stimulation Lead Wire, EMG Lead Wire,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2024-11-15

Official Correspondent

Lidan Qin

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Dongguan Goochain Technology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033919280. Last updated year: 2026. Please use registration number 3033919280 when referencing this establishment in official correspondence.