BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.

    Reg #: 3008648418 · FEI: 3008648418 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    41
    Establishment Types
    3
    Classifications
    21

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    Registration Details

    Registration Name
    ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.
    Registration Number
    3008648418
    FEI Number
    3008648418
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 301, 3rd Floor, Building 2, No. 52, Hongsong Road, High-tech Industrial Development Zone
    City
    Zhengzhou Henan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201483

    Owner / Operator

    Firm Name
    Zhengzhou Huaer Electro-optics Technology Co., Ltd.
    Operator Number
    10040158
    Address
    Room 301, 3rd Floor, Building 2, No. 52, Hongsong Road, High-tech Industrial Development Zone
    City
    Zhengzhou
    State
    Henan
    Postal Code
    450001
    Country
    CN
    Correspondent
    Kaihui Wang

    US Agent

    Business Name
    ABMED MEDICAL TECHNOLOGY INC
    Contact Name
    hui hong
    Address
    800 East Wishkah Street, 1021 Aberdeen,
    City
    Aberdeen
    State
    WA
    ZIP
    98520
    Country
    US
    Email
    [email protected]
    Phone
    509 5816099

    Products

    Device Name Product Code
    Camera, Surgical And Accessories KQM
    Guide, Needle, Surgical GDF
    Scaler, Periodontic EMN
    Toothbrush, Powered JEQ
    Cleanser, Denture, Over The Counter EFT
    Unit, Oral Irrigation EFS
    Heat Source For Bleaching Teeth EEG
    Container, Specimen, Non-Sterile NNI
    Cleaner, Ultrasonic, Medical Instrument FLG
    Pusher, Band, Orthodontic ECS
    Material, Impression Tray, Resin EBH
    Coating, Denture Hydrophilic, Resin EBE
    Eraser, Dental Stain MAU
    Orthosis, Moldable, Supportive, Skin Protective MNE
    Tray, Impression, Preformed EHY
    Toothbrush, Manual EFW
    Retractor, All Types EIG
    Lamp, Infrared, Therapeutic Heating ILY
    Material, Impression ELW
    Plaque Disclosing Kit NYH
    Instruments, Dental Hand DZN

    Proprietary Names

    Intra Oral Camera Micro needling therapy system Teeth Cleaning Kit Electric toothbrush Cleanser, Denture, Denture Cleanser, denture cleaning tablets water flosser Heat Source for Bleaching Teeth Teeth Whitening lamp/Machine/Light Mouth tray box ultrasonic cleaner Chewies Vacuum Forming Material, Pro Guard Mouthguard Material, Pro-form Vacuum Forming Material, Pro- Tray Custom Material Ortho Model Resin 3D printing Resin Water-Washable Ortho Model Resin resin material BlanQuest Home Whitening Kit GB-HOM101 Gingival barrier/Gum protector Mouth Tray teeth whitening essence,teeth whitening serum, Teeth whitening gel, dual barrel syringe gel, professional whitening gel, Coconut oil teeth whitening pulling, bamboo toothbrushes, teeth whitening strips, desentitization gel, remineralization gel, oral spray, mouth trays, teeth cleaning and whitening foam, teeth whitening foam toothpaste, Teeth whitening kit, teeth whitening home kit, teeth whitening system, teeth bleaching system, teeth bleaching kit, Teeth whitening powder, Teeth whitening strips, Teeth whitening pen, bleaching pen, teeth whitener, Charcoal Teeth Whitening Powder, Charcoal teeth whitening strips, charcoal foam toothpaste, gingival barriel, gum protector teeth whitening toner GloboDent Whitening Accelerator GB-GWA101 LuxBrite Personal Teeth Whitening System GB-LB101 LuxBrite Refill Kit GB-LX105 BlanQuest Pro Professional Whitening Treatment Kit GB-PRO101 Luxsmile/Selvra Teeth whitening liquid HR-BSG01 Oxygen Dome Facial Machine Preformed impression tray, Plastic impression tray, impression tray Toothbrush Cheek Retractor Red LED Light Therapy Device Impression Material, Elastomeric Impression Material, Light Body VPS Addition Silicone Elastomeric Impression Material Impression material kit Dental Plaque Indicator Outie tool

    Establishment Types

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