Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009443860

FEI Number

3009443860

Entity Name

BINZHOU DINGYUE CLOTHING COMPANY LIMITED

City/State/Country

Binzhou Shandong, CN

Establishment Address

No.266,Changjiang 1 road,, Binzhou Economic Zone, Binzhou Shandong 256600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BINZHOU DINGYUE CLOTHING COMPANY LIMITED (Owner Number: 10039080)

Owner / Operator Contact Address

No.266,Changjiang 1 road,, Binzhou Economic Zone, Binzhou, CN-SD 256600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STC ID Product Codes NE1, NE2, NE3, NE4, NE5, NE7, NF1 OR Towels Standard Textile Barrier Supreme Sterilization Wrappers Standard Supreme Drapes Barrier Supreme Drapes Standard Supreme Sterilization Wrappers Standard Textile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-11-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-02-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-03-26
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-04-25
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-12-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-03-26
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-07-30
FME	Gown, Examination	General Hospital	Class 1	880.6265	2012-02-10

Official Correspondent

David Liu

US Agent Details

Tim wirrig Business: Standard Textile Company Email: twirrig@standardtextile.com Phone: (513) 7619255

Related Public Records

Same Entity

BINZHOU DINGYUE CLOTHING COMPANY LIMITED

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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
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

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3014666579	SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Zaozhuang Shandong, CN
3007663056	SHANGHAI HUIHU MEDICAL APPLIANCE CO. LTD.	Shanghai, CN
3015068387	GEORGE COUREY INC	Montreal Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009443860. Last updated year: 2026. Please use registration number 3009443860 when referencing this establishment in official correspondence.