Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013427445

FEI Number

3013427445

Entity Name

SHANDONG HENGFA HYGIENIC PRODUCTS CO.,LTD.

City/State/Country

Linqing City,liaocheng City, Shandong, CN

Establishment Address

Fengyang Village,Jinhaozhuang Township,, Linqing City,liaocheng City, Shandong 252600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Hengfa Hygienic Products Co.,Ltd. (Owner Number: 10052977)

Owner / Operator Contact Address

Fengyang Village,Jinhaozhuang Township,, Linqing City,liaocheng City,, CN-SD 252600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BEDDING DISPOABLE MEDICAL breast pad Sanitary Napkins, Postpartum Catch-All Pads Underpad (Relief and Kerae) Menstrual Cup Wipes (Relief and Kerae) Diapers, Pad; Incontinence Underware (Relief" and Kerae) S, M, L, XL, XXL, XXXL Ice maxi pad

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	2020-05-21
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2016-10-20
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2016-10-20
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2016-10-20
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2024-12-08
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-11-17
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-10-20
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2025-04-24

Official Correspondent

XUEHE LIU

US Agent Details

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

Related Public Records

Same Entity

Shandong Hengfa Hygienic 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

Similar Registrations

Registration Number	Establishment Name	Location
3011189534	DS TEXTILE PRODUCTS, INC.	Gulf Shores, AL, US
3040278131	Ozuufuk Tekstil Ith. Ihr. San. Ve Tic. Ltd. Sti	Istanbul, TR
3013682767	SAVE MY FACE, INC.	Valencia, CA, US
3016752930	ZEN LINEN INTERNATIONAL PRIVATE LIMITED.	Chennai Tamil Nadu, IN
3043051417	SUNING JUNQI MEDICAL HYGIENE PRODUCTS (CAMBODIA) CO., LTD.	Kampong Soam Preah Sihanouk, KH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013427445. Last updated year: 2026. Please use registration number 3013427445 when referencing this establishment in official correspondence.