Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016457665

FEI Number

3016457665

Entity Name

SHANDONG AISHULE HYGIENE PRODUCTS CO., LTD

City/State/Country

Linyi Shandong, CN

Establishment Address

Northwest Corner, Qiyang Road and Industrial Three Road intersection,High-tech Zone, Linyi Shandong 276000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Aishule Hygiene Products Co., Ltd (Owner Number: 10062349)

Owner / Operator Contact Address

Northwest Corner, Qiyang Road and Industrial Three Road intersection,High-tech Zone, Linyi, CN-SD 276000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pulp Bed Pads Bed Mattress Aydmed Ped Bad Incontinence Bed Pads Non-woven fabric sanitary napkin Surgical Gown Isolation Gown Wet wipes Bed Sheet Adult Insert Diapers Diapers Baby Diapers Adult Diapers Baby Care Mat Pet Diapers Adult Nursing 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	2020-01-15
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-01-15
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2021-04-06
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-01-15
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-01-15
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-03-03
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-01-15
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2020-01-15

Official Correspondent

Chen Tao

US Agent Details

Creekon Yang Business: SPICA MEDTECH CORP Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Shandong Aishule 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

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3016752930	ZEN LINEN INTERNATIONAL PRIVATE LIMITED.	Chennai Tamil Nadu, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016457665. Last updated year: 2026. Please use registration number 3016457665 when referencing this establishment in official correspondence.