Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013735189

FEI Number

3013735189

Entity Name

3A MEDICAL PRODUCTS CO., LTD.

City/State/Country

LIU AN Anhui, CN

Establishment Address

YuAn Industrial Park, LIU AN Anhui 237100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

3A Medical Products Co., Ltd. (Owner Number: 10055456)

Owner / Operator Contact Address

YuAn Industrial Park, LIU AN, CN-AH 237100, 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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-07-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-07-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-07-28
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-07-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-01
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-04-20
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2020-07-01
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-07-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-21

Official Correspondent

No official correspondent registered.

US Agent Details

SUSAN BARNETT Business: BAM Corporation Ltd. Email: steveandsusan@aol.com Phone: (319) 3210851

Related Public Records

Same Entity

3A Medical 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
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.

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013735189. Last updated year: 2026. Please use registration number 3013735189 when referencing this establishment in official correspondence.