BEUDAMED
    FDA Registration Active 🇨🇳 China

    Shanghai Hua En Industrial Co Ltd

    Reg #: 3010147274 · FEI: 3010147274 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    28
    Establishment Types
    6
    Classifications
    49

    Registration Details

    Registration Name
    Shanghai Hua En Industrial Co Ltd
    Registration Number
    3010147274
    FEI Number
    3010147274
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #30, NO988 HUI JI ROAD, XUANQIAO, TOWN, PUDONG
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212578

    Owner / Operator

    Firm Name
    SHANGHAI HUA EN INDUSTRIAL CO LTD
    Operator Number
    10043241
    Address
    #30,NO988 HUI JI ROAD, XUANQIAO TOWN, PUDONG
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201314
    Country
    CN
    Correspondent
    Lisa Zhao

    US Agent

    Business Name
    UG HEALTHCARE
    Contact Name
    Patrick Stanton
    Address
    1565 Sunflower Avenue
    City
    Costa Mesa
    State
    CA
    ZIP
    92626
    Country
    US
    Email
    [email protected]
    Phone
    800 3287981

    Products

    Device Name Product Code
    Accessory, Surgical Apparel LYU
    Adaptor, Hygiene ILS
    Garment, Protective, For Incontinence EYQ
    Cotton, Roll EFN
    Shield, Protective, Personnel KPY
    Unit, Syringe, Air And/Or Water ECB
    Cover, Mattress (Medical Purposes) FMW
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Tray, Surgical, Instrument FSM
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Chair, Dental, Without Operative Unit NRU
    Tip, Rubber, Oral Hygiene JEW
    Mirror, Mouth EAX
    Syringe, Restorative And Impression Material EID
    Toothbrush, Manual EFW
    Polymer Patient Examination Glove LZA
    Cap, Surgical FYF
    Tray, Impression, Preformed EHY
    Syringe, Irrigating (Dental) EIB
    Evacuator, Oral Cavity EHZ
    Non-Surgical Gown OEA
    Gown, Examination FME
    Absorber, Saliva, Paper KHR
    Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter NKJ
    Tape And Bandage, Adhesive KGX
    Accessories, Retractor, Dental EIF
    Tray, Fluoride, Disposable KMT
    Needle, Dental DZM
    Gauze / Sponge,Nonresorbable For External Use NAB
    Cover, Shoe, Operating-Room FXP
    Unit, Operative Dental, Accessories NRD
    Bedding, Disposable, Medical KME
    Mouthpiece, Saliva Ejector DYN
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Barrier, Control Panel, X-Ray, Movable IWX
    Probe, Periodontic EIX
    Chart, Visual Acuity HOX
    Razor, Surgical LWK
    Mask, Surgical FXX
    Scalpel, One-Piece GDX
    Wrap, Sterilization FRG
    Indicator, Physical/Chemical Sterilization Process JOJ
    Handle, Instrument, Dental EJB
    Instrument, Filling, Plastic, Dental EIY
    Dispenser, Liquid Medication KYX
    Apron, Protective IWO
    Mixer, Cement, For Clinical Use JDZ
    Fiber, Medical, Absorbent FRL
    Depressor, Tongue, Non-Surgical FMA

    Proprietary Names

    Denture box Shield Airway Syringe Mattress Cover Surgical Tray Headrest Covers Oral Tip Oral Mirror UniPack toothbrush Nitrile Disposable Examination Gloves Caps UniPack Impression Tray Irrigating Syringe Examination Gown Cotton Pad bur holder Shoe Covers sleeves Probe Visual Acuity Chart Surgical Face Mask Scalpel Sterilization Pouch and Roll disposable dental kits Plastic Filling Cement Mixing Bowl CSR Wrap

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device