Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011390041

FEI Number

3011390041

Entity Name

ZHANGJIAGANG JIAYIN SANITARY PRODUCTS CO., LTD.

City/State/Country

Zhangjiagang City Jiangsu, CN

Establishment Address

Building No.9 & Building No.10, No. 8, JiFu Road, Fenghuang Town, Zhangjiagang City Jiangsu 215613, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhangjiagang Jiayin Sanitary Products Co., Ltd. (Owner Number: 10048078)

Owner / Operator Contact Address

Building No.9 & Building No.10, No. 8, JiFu Road, Fenghuang Town, Zhangjiagang City, CN-JS 215613, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Underpad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-01-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-12-03
OXZ	Pediatric/Child Facemask	General, Plastic Surgery	Class 2	878.4040	2019-11-04

Official Correspondent

Jennifer Zhu

US Agent Details

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

Related Public Records

Same Entity

Zhangjiagang Jiayin Sanitary Products 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011390041. Last updated year: 2026. Please use registration number 3011390041 when referencing this establishment in official correspondence.