Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006113262

FEI Number

3006113262

Entity Name

XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.

City/State/Country

XIANTAO Hubei, CN

Establishment Address

NO.258 PENGCHANG ROAD, MIDDLE STREET, XIANTAO Hubei 433018, CN

Establishment Type(s)

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

Owner / Operator

XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. (Owner Number: 9089380)

Owner / Operator Contact Address

NO. 258 PENGCHANG ROAD, MIDDLE STREET, XIANTAO CITY, CN-HB 433018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ForSure Holder, Catheter, Foley ForSure Shoe Covers Non-Skid bouffant cap ForSure Surgical Cap ForSure Nurses Cap surgical gown ForSure Surgical Gown surgical face masks with ties surgical face masks with earloops Thumbloop Gowns ForSure Isolation Gown ForSure Face Mask with Earloop ForSure Face Mask with Tie and Shield ForSure Face Mask with Tie ForSure Apron Disposable PE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-12-03
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2012-11-22
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-08-14
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2012-07-22
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-03-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2007-06-06
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2023-02-16
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-20
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2007-11-07
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2015-10-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-02-27
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-11-19
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2008-12-03
FME	Gown, Examination	General Hospital	Class 1	880.6265	2013-12-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2007-11-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2006-07-13

Official Correspondent

Qichao Li

US Agent Details

Zhen Li Business: Rayxin Inc Email: Henryli0322@gmail.com Phone: (760) 7803575

Related Public Records

Same Entity

XIANTAO RAYXIN 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006113262. Last updated year: 2026. Please use registration number 3006113262 when referencing this establishment in official correspondence.