Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025831202

FEI Number

3025831202

Entity Name

TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

No. 4 Xinyuan Street, Xinwei, Shilong Town, Dongguan City Guangdong 523291, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TKR Huanan Electronics (Dongguan) Co., Ltd. (Owner Number: 10087019)

Owner / Operator Contact Address

No. 4 Xinyuan Street, Xinwei, Shilong Town, Dongguan City, CN-GD 523291, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aspirator Aspirator Aspirator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-01-03
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2023-01-03
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-12-28

Official Correspondent

Youhei Mitsuhashi

US Agent Details

Kazumasa Yamafuji Business: Baby Health Care, Inc. Email: kaz.y@babyhealthcare.us Phone: (714) 2692013

Related Public Records

Same Entity

TKR Huanan Electronics (Dongguan) Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN
2126670	SCANLAN INTERNATIONAL, INC.	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025831202. Last updated year: 2026. Please use registration number 3025831202 when referencing this establishment in official correspondence.