Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010147274

FEI Number

3010147274

Entity Name

Shanghai Hua En Industrial Co Ltd

City/State/Country

Shanghai, CN

Establishment Address

#30, NO988 HUI JI ROAD, XUANQIAO, TOWN, PUDONG, Shanghai 201314, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANGHAI HUA EN INDUSTRIAL CO LTD (Owner Number: 10043241)

Owner / Operator Contact Address

#30,NO988 HUI JI ROAD, XUANQIAO TOWN, PUDONG, Shanghai, CN-SH 201314, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Denture box Shield Airway Syringe Mattress Cover Surgical Tray Headrest Covers Oral Tip Oral Mirror UniPack UniPack toothbrush Nitrile Disposable Examination Gloves Caps UniPack Impression Tray Irrigating Syringe Examination Gown Cotton Pad bur holder UniPack Shoe Covers sleeves UniPack Probe Visual Acuity Chart

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	2013-01-31
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-10-19
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2013-01-31
EFN	Cotton, Roll	Dental	Class 1	872.6050	2013-01-31
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-01-24
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2015-10-19
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-01-24
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2016-07-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-01-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-12-12
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2021-07-19
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2015-10-19
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2015-10-19
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2016-12-06
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2018-09-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-24
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-07-19
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2014-08-12
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2021-07-20
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2013-01-31
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2016-12-06
FME	Gown, Examination	General Hospital	Class 1	880.6265	2024-01-24
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2013-01-31
NKJ	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Dental	Class 1	872.3540	2024-01-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-01-31
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2015-10-19
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2016-12-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2016-07-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2013-01-31
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2021-07-19
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2015-10-19
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2013-01-31
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2013-01-31
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2013-01-31
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2016-12-06
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2015-10-19
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2024-08-06

Official Correspondent

Lisa Zhao

US Agent Details

Patrick Stanton Business: UG HEALTHCARE Email: pat@ughealthcare.com Phone: (800) 3287981

Related Public Records

Same Entity

SHANGHAI HUA EN INDUSTRIAL 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

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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 3010147274. Last updated year: 2026. Please use registration number 3010147274 when referencing this establishment in official correspondence.