Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016948452

FEI Number

3016948452

Entity Name

QINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Qinhuangdao Hebei, CN

Establishment Address

Workshop 5, small and medium-sized enterprise incubation base, East Longgang Road, Haigang District, Qinhuangdao Hebei 066000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Qinhuangdao Taizhi Medical Technology Co., Ltd (Owner Number: 10066128)

Owner / Operator Contact Address

Small And Medium Enterprises Incubator Base East Circular Economy Park, Haigang District, Qinhuangdao, CN-HE 066000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shield, protective, personnel Medical Protective Masks Disposable Surgical Mask (Non Sterile) MASK, SCAVENGING Respirator, surgical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-01
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-14
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-25
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-12-09
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-01

Official Correspondent

Xi fan Fan

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

Qinhuangdao Taizhi 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Similar Registrations

Registration Number	Establishment Name	Location
3000174892	CANADIAN SCIENTIFIC PRODUCTS LTD. DBA CSP MEDICAL	London Ontario, CA
3029900933	LEMER PAX AMERICA	Montreal Quebec, CA
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3005257704	BEIJING KELIDA MEDICAL EQUIPMENT DEVELOPING CO., LTD	Beijing City, CN
3023863246	GUANGZHOU NEWLIFE MAGNETICS CO., LTD.	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016948452. Last updated year: 2026. Please use registration number 3016948452 when referencing this establishment in official correspondence.