Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004566918

FEI Number

3004566918

Entity Name

LUEN HING TEXTILE -Shangyu Manufacturing(ZHONG SHAN) CO LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

Sanjiao Town, No. 13 Gold Three Avenue East, Zhongshan Guangdong 528425, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LUEN HING TEXTILE COMPANY LTD. (Owner Number: 9084761)

Owner / Operator Contact Address

1129 Dunnavant Place, Birmingham, AL 35242, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PHILIPS Disposable abdominal belt M2208A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-03-23
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2024-08-27

Official Correspondent

Charles Hoit

US Agent Details

Charles Hoit Business: MAS Corp. Email: choit@bellsouth.net Phone: (205) 5416455

Related Public Records

Same Entity

LUEN HING TEXTILE COMPANY 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
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

Similar Registrations

Registration Number	Establishment Name	Location
3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004566918. Last updated year: 2026. Please use registration number 3004566918 when referencing this establishment in official correspondence.