Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008191511

FEI Number

3008191511

Entity Name

SHANTOU CHAONAN LIANGYING HEGAO PLASTIC TOY FACTORY

City/State/Country

SHANTOU Guangdong, CN

Establishment Address

HEGAO VILLAGE, LIANGYING TOWN, CHAONAN DISTRICT,, SHANTOU, GUANGDONG PROVINCE, SHANTOU Guangdong 515141, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

ELUNG INDUSTRIAL CO.LTD. (Owner Number: 9052953)

Owner / Operator Contact Address

SUITE 507, SILVERCORD,, TOWER 1, 30 CANTON ROAD, T.S.T.,KOWLOON, HONG KONG, CN-NOTA --, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

APPARATUS SINGLE PATIENT USE PORTABLE NONPOWERE Gel Soothers TOOTHBRUSH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2006-11-01
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2009-12-31
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2013-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

Joseph Hakim Email: josephh@nuby.com Phone: (318) 3383172

Related Public Records

Same Entity

ELUNG INDUSTRIAL CO.LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010626066	Dongguan Qing Xi Essentia Industries Ltd	Dongguan Guangdong, CN
3006610790	ELUNG INDUSTRIAL CO.LTD.	T.S.T.,KOWLOON, HONG KONG, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3017101761	IC SURGICAL INC	Grand Rapids, MI, US
3010198939	TIANJIN VANFORM HIGH ENERGY PHYSICS TECHNOLOGY CO., LTD.	Tianjin, CN
3013025177	Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, CN
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3026986849	FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD .	Zhongshan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008191511. Last updated year: 2026. Please use registration number 3008191511 when referencing this establishment in official correspondence.