Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015219076

FEI Number

3015219076

Entity Name

HONGHU DANIELLE SANITARY MATERIAL CO., LTD.

City/State/Country

Honghu City Hubei, CN

Establishment Address

No.118, Chenzhao Village,Fengkou Town,, Honghu City Hubei 433202, CN

Establishment Type(s)

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

Owner / Operator

Honghu Danielle Sanitary Material Co., Ltd. (Owner Number: 10059411)

Owner / Operator Contact Address

No.118, Chenzhao Village,Fengkou Town,, Honghu City, CN-HB 433202, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

underpads ,isolation gown CAP, SURGICAL ABSORBER, SALIVA, PAPER PAPERS, ION COVER, SHOE, OPERATING-ROOM Shield, protective, personnel COVER, MATTRESS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2019-01-29
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-01-29
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-02-12
DMG	Papers, Ion	Clinical Chemistry	Class 1	862.2230	2019-01-29
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2019-01-29
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2019-01-29
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2019-02-12

Official Correspondent

Hongli CHENG

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Honghu Danielle Sanitary Material Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015219076. Last updated year: 2026. Please use registration number 3015219076 when referencing this establishment in official correspondence.