Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004127962

FEI Number

3004127962

Entity Name

ZHANGZHOU AOXI PLASTIC CO., LTD.

City/State/Country

ZHANGZHOU Fujian, CN

Establishment Address

No 6 Yonghui Road, YANXI TOWN, CHANGTAI DISTRICT, ZHANGZHOU Fujian 363900, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ZHANGZHOU AOXI PLASTIC CO., LTD. (Owner Number: 9058002)

Owner / Operator Contact Address

MINYING INDUSTRIAL DISTRICT, YANXI TOWN, CHANGTAI, ZHANGZHOU, FUJIAN, CN-NOTA 363902, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052843

PMA Number

N/A

All Registered Proprietary Names

FOR INDWELLING CATHETER GASTROENTE URINARY DRAINAGE COLLECTION ROLOGY-UROLO SPECIMEN STERILE#GENERAL HOSPITAL NON-STERILE#GENERAL HOSPITAL ABSORBENT TIPPED CURETTE UTERINE OBSTETRICS AND GYNECOLOGY SAF-T-CUBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2005-09-16
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2003-08-12
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2003-08-12
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2005-09-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2006-08-25

Official Correspondent

PETER JAMES BOYLE

US Agent Details

Brenda Rojas Business: Busse Hospital Disposables Email: brojas@busseinc.com Phone: (800) 6456526

Related Public Records

Same Entity

ZHANGZHOU AOXI PLASTIC 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

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3009888344	Isomedix Operations Inc	El Paso, TX, US
3007007790	Sterigenics Shanghai ETO Ltd.	Shanghai, CN
3015058854	JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD.	Changzhou Jiangsu, CN
3014195785	CLINISUPPLIES (NANJING) CO., LTD	Nanjing Jiangsu, CN
3005595283	MEDLINE INDUSTRIES, LP - Laredo	LAREDO, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004127962. Last updated year: 2026. Please use registration number 3004127962 when referencing this establishment in official correspondence.