Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015781813

FEI Number

3015781813

Entity Name

DONG GUAN DANCHEN ELECTRICAL PRODUCTS LTD.

City/State/Country

DONG GUAN CITY Guangdong, CN

Establishment Address

XIN FENG DONG LU, XIN CHENG DISTRICT, SHIJIE TOWN,, DONG GUAN CITY, GUANG DONG PROVINCE, CHINA, DONG GUAN CITY Guangdong China, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DONG GUAN DANCHEN ELECTRICAL PRODUCTS LTD. (Owner Number: 10061148)

Owner / Operator Contact Address

XIN FENG DONG LU, XIN CHENG DISTRICT, SHIJIE TOWN,, DONG GUAN CITY, CN-GD China, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ATA 3 Cable Assembly ATA Cable 36 in, Algo Pro Disposable Clip-on Leadwire; Disposable Multistage Leadwire; Extender Pods; Mini-Crocodile Clip Lead Wires; Probe Extens ATA 3 Cable Assembly Echo Screen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-05-01
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-05-01
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-08-30
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-05-01
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-05-01

Official Correspondent

Mencius Yu-Ming Hsieh

US Agent Details

Sarah Nugent Business: Global Interconnect Email: snugent@globalinterconnect.com Phone: (508) 5636306

Related Public Records

Same Entity

DONG GUAN DANCHEN ELECTRICAL PRODUCTS LTD.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3004920696	GLOBAL INTERCONNECT, INC.	Pocasset, MA, US
3008773490	PAUL E. DANCHELL A/S	Jyderup Sjalland, DK
8030229	NIHON KOHDEN TOMIOKA PRODUCTION CENTER	TOMIOKA-SHI Gunma, JP
1650946	COMPUMEDICS USA, INC.	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015781813. Last updated year: 2026. Please use registration number 3015781813 when referencing this establishment in official correspondence.