Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011091529

FEI Number

3011091529

Entity Name

CHANGZHOU HONGTAI PAPER FILM CO., LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.73 Donghu Road, Henglin Town, Changzhou Jiangsu 213000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

CHANGZHOU HONGTAI PAPER FILM CO., LTD (Owner Number: 10047188)

Owner / Operator Contact Address

No.73 Donghu Road, Henglin Town,, Changzhou, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Face Mask Face Mask SALIVA EJECTORS Table Cover Paper pet diaper adult diaper DISPOSABLE UNDERPAD disposable pillow case Thumbloop Gown CPE Gown Sterile Medical Sampler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-06-15
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2026-06-10
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2014-07-15
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2023-03-01
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-07-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-07-17
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-29
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2022-02-22

Official Correspondent

Charles Shen

US Agent Details

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

Related Public Records

Same Entity

CHANGZHOU HONGTAI PAPER FILM 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Similar Registrations

Registration Number	Establishment Name	Location
3017179438	CARENOW MEDICAL PVT LTD	Coimbatore Tamil Nadu, IN
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3016126870	Quanzhou Tianjiao Lady & Baby's Hygiene Supply Co., Ltd.	Quanzhou Fujian, CN
3014819517	WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.	Suzhou Jiangsu, CN
3005078659	NAN'AN HENGYUAN HYGIENE PRODUCTS CO., LTD.	Nanan Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011091529. Last updated year: 2026. Please use registration number 3011091529 when referencing this establishment in official correspondence.