Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004713352

FEI Number

3004713352

Entity Name

Lianyungang Aiyeh Non-woven Products Co., Ltd.

City/State/Country

Lianyungang Jiangsu, CN

Establishment Address

No. 9 Yunyang Rd., Lianyungang Economic and Technological Development Area Comprehensive Bonded Zone, China (Jiangsu) Pilot Free Trade Zone, Lianyungang Jiangsu 222047, CN

Establishment Type(s)

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

Owner / Operator

LYG AIYEH NONWOVEN PRODUCTS CO., LTD. (Owner Number: 9065777)

Owner / Operator Contact Address

No.9 Yunyang Rd., Lianyungang Economic and Technological Development Area Comprehensive Bonded Zone, China (Jiangsu) Pilot Free Trade Zone, Lianyungang, CN-JS 222047, 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
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2010-12-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2004-08-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-08-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-01-26
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2009-12-16
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-01-26
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2024-12-19

Official Correspondent

Xuefeng Zhang

US Agent Details

Solomon Chen Email: solomon@aplusgroup.net Phone: (909) 5915168

Related Public Records

Same Entity

LYG AIYEH NONWOVEN PRODUCTS 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
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
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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3016752930	ZEN LINEN INTERNATIONAL PRIVATE LIMITED.	Chennai Tamil Nadu, IN
3043051417	SUNING JUNQI MEDICAL HYGIENE PRODUCTS (CAMBODIA) CO., LTD.	Kampong Soam Preah Sihanouk, KH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004713352. Last updated year: 2026. Please use registration number 3004713352 when referencing this establishment in official correspondence.