Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008381089

FEI Number

3008381089

Entity Name

WUHAN LUCKY STAR NON WOVEN PRODUCTS CO LTD

City/State/Country

Wuhan Hubei, CN

Establishment Address

Xingguang Industry Park, Zhashan Street Caidian Town, Wuhan Hubei 433000, CN

Establishment Type(s)

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

Owner / Operator

Wuhan Lucky Star Non Woven Products Co Ltd (Owner Number: 10032261)

Owner / Operator Contact Address

Xingguang Industry Park, Zhashan Street Caidian Town, Xiantao, CN-HB 433000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Apparel Patient Gown Disposable Pillow Cover,Disposable bed Sheet,Exam Roll Operating Room Shoe Cover Disposable Hood Scrub suits ARMBOARDS Apron TABLE STRAPS

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	2010-04-26
FME	Gown, Examination	General Hospital	Class 1	880.6265	2022-12-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-12-13
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2010-04-26
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2022-12-21
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2018-12-13
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2024-07-11
IWO	Apron, Protective	Radiology	Class 1	892.6500	2018-12-13
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2024-07-11

Official Correspondent

Yan Kai

US Agent Details

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

Related Public Records

Same Entity

Wuhan Lucky Star Non Woven 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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

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 3008381089. Last updated year: 2026. Please use registration number 3008381089 when referencing this establishment in official correspondence.