Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011500469

FEI Number

3011500469

Entity Name

FENGYANG JIEHONG NONWOVEN PRODUCT CO., LTD.

City/State/Country

Chuzhou City Anhui, CN

Establishment Address

Menlin Road, Zheshang industrial zone, Fengyang County, Chuzhou City Anhui 233100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fengyang Jiehong Nonwoven Product Co., Ltd. (Owner Number: 10048040)

Owner / Operator Contact Address

Menlin Road, Zheshang industrial zone, Fengyang County, Chuzhou City, CN-AH 233100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-03-05
FME	Gown, Examination	General Hospital	Class 1	880.6265	2019-04-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-12-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-12-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-30
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-10
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-02-28

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Fengyang Jiehong Nonwoven Product 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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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2022435	Sterigenics U.S., LLC	Tustin, CA, US
2648727	CUSTOMED, INC.	Fajardo, PR, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011500469. Last updated year: 2026. Please use registration number 3011500469 when referencing this establishment in official correspondence.