Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005635368

FEI Number

3005635368

Entity Name

DONGGUAN TEAC ELECTRONICS CO., LTD.

City/State/Country

Dong Guan Guangdong, CN

Establishment Address

NO.1 SHANGXING LU,SHANGJIAO COMMUNITY,CHANGAN TOWN, Dong Guan Guangdong 523878, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TEAC Corporation (Owner Number: 10047784)

Owner / Operator Contact Address

1-47 Ochiai, Tama-shi, JP-13 206-8530, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MDR-600HD UR-4MD UR-X UR-NEXT4KS UR-NEXT4KH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2014-10-31

Official Correspondent

Motoyuki Kamado

US Agent Details

RYO MAEKAWA Business: TEAC AMERICA, INC. Email: rmaekawa@teac.com Phone: (323) 7260303

Related Public Records

Same Entity

TEAC Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008347129	TEAC MANUFACTURING SOLUTIONS CORPORATION	OME-SHI Tokyo, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005635368. Last updated year: 2026. Please use registration number 3005635368 when referencing this establishment in official correspondence.