Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042278984

FEI Number

3042278984

Entity Name

Qingdao Zexinyuan Medical Technology Co., Ltd.

City/State/Country

Qingdao Shandong, CN

Establishment Address

Changwang Road North, West Side of National Highway 204, Jiangshan Town, Laixi City, Qingdao Shandong 266600, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Qingdao Zexinyuan Medical Technology Co., Ltd. (Owner Number: 10094408)

Owner / Operator Contact Address

Changwang Road North, West Side of National Highway 204, Jiangshan Town, Laixi City, Qingdao, CN-SD 266600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Toothbrush Tongue scraper Toothbrush; Interdental Brush Head Non-surgical Isolation Gown Eyelash brush Isolation mask Floss, Dental Floss, Dental Floss Pick, Interdental Brush, Dental flossThreader, Dental Floss Box, dental floss holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-11-27
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2025-11-27
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-11-27
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2025-11-27
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2025-11-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-11-27
JES	Floss, Dental	Dental	Class 1	872.6390	2025-11-27

Official Correspondent

Sifeng Mei

US Agent Details

Aokai Tang Business: AOKT STUDIO LLC Email: aokt-service@outlook.com Phone: (757) 2240177

Related Public Records

Same Entity

Qingdao Zexinyuan Medical Technology 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Similar Registrations

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3029987245	FLAUS, INC.	New York, NY, US
3013257234	MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD	Dongguan Guangdong, CN
3038200340	WEIFANG YANGXU LABOR PROTECTION PRODUCTS CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042278984. Last updated year: 2026. Please use registration number 3042278984 when referencing this establishment in official correspondence.