Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010626066

FEI Number

3010626066

Entity Name

Dongguan Qing Xi Essentia Industries Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Building 2, No. 94, Yanhe East 1st Road, Dongkeng Town, Dongguan, Guangdong, China, Dongguan Guangdong 523456, CN

Establishment Type(s)

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 Perineal Massager & Pelvic Wand TEETHING LUV N'CARE NON-FLUID FILLED NUBY RING PARENT'S CHOICE

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
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2010-03-25
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2009-12-31
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2025-08-04
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-06-25
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2006-11-01

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
3008191511	SHANTOU CHAONAN LIANGYING HEGAO PLASTIC TOY FACTORY	SHANTOU 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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010626066. Last updated year: 2026. Please use registration number 3010626066 when referencing this establishment in official correspondence.