Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021247124

FEI Number

3021247124

Entity Name

TAIZHOU XINJUN INTERNATIONAL TRADE CO., LTD

City/State/Country

Taizhou Jiangsu, CN

Establishment Address

73# Xiaqi Road, Suchen Town,, Taizhou Jiangsu 225300, CN

Establishment Type(s)

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

Owner / Operator

Taizhou Xinjun International Trade Co., Ltd (Owner Number: 10083232)

Owner / Operator Contact Address

73# Xiaqi Road, Suchen Town,, Taizhou, CN-JS 225300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NON-STERILE TRIANGULAR BANDAGE TWISTED WIRE TRACHEA BRUSH SHOE COVER ANTI-SKID; SHOE COVER REGULAR COTTON ROLL LAP SPONGES; NON-STERILE X-RAY DETECTABLE GAUZE SPONGES PROTECTIVE GOWNS NON-STERILE NON-WOVEN SPONGES NON-STERILE COTTON TIP APPLICATOR BOUFFANT CAP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2021-11-04
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2021-11-04
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2021-11-04
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-11-04
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2021-11-04
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-11-04
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2021-11-04
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-11-04
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-11-04

Official Correspondent

WANGGUO XU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Taizhou Xinjun International Trade 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
3007123908	APOTHECARIES SUNDRIES MFG PVT LTD	GURUGRAM Haryana, IN
3006633581	SUZHOU VICON INDUSTRIAL CO., LTD	SUZHOU Jiangsu, CN
3013002868	BRACE ALIGN	Soddy Daisy, TN, US
3010220099	RIVAL VIETNAM CO.,LTD	HUNG YEN PROVINCE, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021247124. Last updated year: 2026. Please use registration number 3021247124 when referencing this establishment in official correspondence.