Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008381943

FEI Number

3008381943

Entity Name

FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD

City/State/Country

Nanan Fujian, CN

Establishment Address

HONGGONGSHAN DEVELOPMENT ZONE, HONGLAI TOWN, Nanan Fujian 362331, CN

Establishment Type(s)

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

Owner / Operator

FUJIAN TIME AND TIANHE INDUSTRIAL CO., LTD (Owner Number: 10032327)

Owner / Operator Contact Address

HONGGONGSHAN DEVELOPMENT ZONE, HONGLAI TOWN, NANAN CITY, CN-FJ 362331, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask Nursing Pad/Under Pad Diaper Sanitary Napkin Respirator KN90,KN95,KN100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-11
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-11-05
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-12-23
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2010-05-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

Charlie Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

FUJIAN TIME AND TIANHE INDUSTRIAL 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
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
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3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008381943. Last updated year: 2026. Please use registration number 3008381943 when referencing this establishment in official correspondence.