Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016860525

FEI Number

3016860525

Entity Name

HANGZHOU SHUJIE HYGIENE PRODUCTS CO., LTD

City/State/Country

Hangzhou City Zhejiang, CN

Establishment Address

Sanbaitan Village, Renhe Street, Yuhang District, Hangzhou City Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANGZHOU SHUJIE HYGIENE PRODUCTS CO., LTD (Owner Number: 10089676)

Owner / Operator Contact Address

Sanbaitan Village, Renhe Street, Yuhang District, Hangzhou City, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Mask, Face Mask, Medical Mask, Protective Face Mask, Surgical Mask, Masks Sanitary Napkin, Sanitary Pad, Maternity Pad, Post-Partum Pad, Under Pad, Nursing Pad, Lady Pants, Menstruation Pants, Period Pants, Panty Liners, Liners, Pet Pad, Puppy Pad Incontinent Pad KN 95 Mask, KN 95 Respirators, N95 Mask, N95 Respirators Booster Pad, Disposable Underwear, Underpad Adult Diaper, Adult Briefs, Adult Pull-Ups, Adult Pants, Baby Diaper, Baby Pull-Ups, Baby Pants, Pet Diaper, Insert Pad, Bedsheet/Sheet, Underpad Wet Wipe, Baby Wipe, Adult Wipe

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	2023-12-28
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2023-12-28
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-12-28
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-12-28
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2023-12-28
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-12-28
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-12-28

Official Correspondent

Wanquan Li

US Agent Details

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

Related Public Records

Same Entity

HANGZHOU SHUJIE HYGIENE 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
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
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
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 3016860525. Last updated year: 2026. Please use registration number 3016860525 when referencing this establishment in official correspondence.