Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026858378

FEI Number

3026858378

Entity Name

KILO-PROMISE HEALTHCARE (SHANDONG) CO.,LTD.

City/State/Country

Dongying City Shandong, CN

Establishment Address

NO 161, Xuanzhou Road, Economic Development Zone, Dongying City Shandong 257000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kilo-Promise Healthcare (Shandong) Co.,Ltd. (Owner Number: 10087398)

Owner / Operator Contact Address

NO 161, Xuanzhou Road, Economic Development Zone, Dongying City, CN-SD 257000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wipes Sanitary pad Underpads Diaper, Liner pad

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	2023-02-22
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2023-02-22
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-02-28
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2023-02-22

Official Correspondent

Tony Pei

US Agent Details

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

Related Public Records

Same Entity

Kilo-Promise Healthcare (Shandong) 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026858378. Last updated year: 2026. Please use registration number 3026858378 when referencing this establishment in official correspondence.