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Data / Medical devices / China / Shanghai Hua En Industrial Co Ltd

Shanghai Hua En Industrial Co Ltd: FDA-registered device maker in Shanghai, China, 8 510(k) clearances

Shanghai Hua En Industrial Co Ltd is registered with the FDA (registration 3010147274) in Shanghai, China. It lists 52 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 30, 2023. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Shanghai Hua En Industrial Co Ltd
FDA registration number
3010147274
Address
#30, No988 Hui Ji Road, Xuanqiao Town, Pudong, Shanghai, China, 201314
Owner or operator
SHANGHAI HUA EN INDUSTRIAL CO LTD (10043241)
Roles
Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed
January 31, 2013
Registered through
2027
Brand names listed
Airway Syringe, CSR Wrap, Caps, Cement Mixing Bowl, Cotton Pad, Denture box, Examination Gown, Headrest Covers and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Exporter to the USaccessdata.fda.gov
Accessories, Retractor, DentalEIF1Exporter to the USaccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Adaptor, HygieneILS1Exporter to the USaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the USaccessdata.fda.gov
Apron, ProtectiveIWO1Exporter to the USaccessdata.fda.gov
Barrier, Control Panel, X-Ray, MovableIWX1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Exporter to the USaccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Exporter to the USaccessdata.fda.gov
Chart, Visual AcuityHOX1Manufactureraccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Exporter to the USaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Exporter to the USaccessdata.fda.gov
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The CounterNKJ1Exporter to the USaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Exporter to the USaccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Exporter to the USaccessdata.fda.gov
Evacuator, Oral CavityEHZ1Exporter to the USaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Exporter to the USaccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Handle, Instrument, DentalEJB1Exporter to the USaccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Exporter to the USaccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Exporter to the USaccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Exporter to the USaccessdata.fda.gov
Needle, DentalDZM1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Probe, PeriodonticEIX1Exporter to the USaccessdata.fda.gov
Razor, SurgicalLWK1Exporter to the USaccessdata.fda.gov
Scalpel, One-PieceGDX1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developeraccessdata.fda.gov
Shield, Protective, PersonnelKPY1Exporter to the USaccessdata.fda.gov
Syringe, AntistickMEG2Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Exporter to the USaccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Manufactureraccessdata.fda.gov
Tip, Rubber, Oral HygieneJEW1Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the USaccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Exporter to the USaccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Exporter to the USaccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Exporter to the USaccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 30, 2023K230061Insulin SyringeFMFSubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
February 13, 2023K221875Sterilization Pouch and RollFRGSubstantially EquivalentQianjiang Kingphar Medical Packaging & Printing Co., Ltd.accessdata.fda.gov
August 17, 2022K221838Surgical Face Mask (HNFM0103)FXXSubstantially EquivalentShanghai Hua EN Industrial Co, Ltd.accessdata.fda.gov
June 6, 2022K221222Surgical Face Mask (HNFM0304)FXXSubstantially EquivalentShanghai Hua EN Industrial Co, Ltd.accessdata.fda.gov
December 2, 2021K212578Nitrile disposable examination glovesLZASubstantially EquivalentXingyu Medical Tech Co., Ltd.accessdata.fda.gov
November 15, 2021K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleMEGSubstantially EquivalentJiangsu Kangbao Medical Equipment Co., Ltd.accessdata.fda.gov
October 18, 2021K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEGSubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
March 7, 2016K152824MEDT PEN NEEDLEFMISubstantially EquivalentShandong Caremed Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.