Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014626425

FEI Number

3014626425

Entity Name

INSOFTB(CHINA) CO., LTD.

City/State/Country

JINJIANG Fujian, CN

Establishment Address

ZHIZAO AVENUE, ECONOMY DEVELOPMENT ZONE, JINJIANG Fujian 362200, CN

Establishment Type(s)

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

Owner / Operator

INSOFTB(CHINA) CO., LTD. (Owner Number: 10081172)

Owner / Operator Contact Address

ZHIZAO AVENUE, ECONOMY DEVELOPMENT ZONE, JINJIANG, CN-FJ 362200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wet wipes Cotton towel Sanitary napkin Disposable medical mask Adult diapers Period pants Baby diapers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-03-22
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2021-03-22
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2021-03-22
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2021-03-22
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2021-03-22

Official Correspondent

Jianfeng Su

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

INSOFTB(CHINA) 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

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3007031049	MINIPAC PRODUCTS LTD	Kadima-Zoran Central, IL
3008697511	Geann Industrial Co Ltd	Lukang Town Changhua, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014626425. Last updated year: 2026. Please use registration number 3014626425 when referencing this establishment in official correspondence.