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Data / Medical devices / China / Zhengzhou Huaer Electro-Optics Technology Co., Ltd.

Zhengzhou Huaer Electro-Optics Technology Co., Ltd.: FDA-registered device maker in Zhengzhou Henan, China, 1 510(k) clearance

Zhengzhou Huaer Electro-Optics Technology Co., Ltd. is registered with the FDA (registration 3008648418) in Zhengzhou Henan, China. It lists 21 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 8, 2020. Registered through 2027. FDA data exported November 3, 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.

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FDA registration number
3008648418
Address
Room 301, 3rd Floor, Building 2, No. 52, Hongsong Road, High-tech Industrial Development Zone, Zhengzhou Henan, China, 450001
Owner or operator
Zhengzhou Huaer Electro-optics Technology Co., Ltd. (10040158)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
March 14, 2012
Registered through
2027
Brand names listed
3D printing Resin, BlanQuest Home Whitening Kit GB-HOM101, BlanQuest Pro Professional Whitening Treatment Kit GB-PRO101, Charcoal Teeth Whitening Powder, Charcoal teeth whitening strips, charcoal foam toothpaste,, Cheek Retractor, Chewies, Cleanser, Denture, Denture Cleanser, denture cleaning tablets, Coconut oil teeth whitening pulling, bamboo toothbrushes, teeth whitening strips, desentitization gel, and more

Devices it lists

DeviceProduct codeClassRoleSource
Camera, Surgical And AccessoriesKQM1Exporter to the US, Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Cleanser, Denture, Over The CounterEFT1Exporter to the US, Manufactureraccessdata.fda.gov
Coating, Denture Hydrophilic, ResinEBE2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the US, Manufactureraccessdata.fda.gov
Eraser, Dental StainMAU1Exporter to the US, Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Exporter to the US, Manufactureraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Exporter to the US, Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the US, Manufactureraccessdata.fda.gov
Material, ImpressionELW2Exporter to the US, Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Moldable, Supportive, Skin ProtectiveMNE1Exporter to the US, Manufactureraccessdata.fda.gov
Plaque Disclosing KitNYH2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the US, Manufactureraccessdata.fda.gov
Scaler, PeriodonticEMN1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Toothbrush, ManualEFW1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Toothbrush, PoweredJEQ1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter to the US, Manufactureraccessdata.fda.gov
Unit, Oral IrrigationEFS1Contract manufacturer, Exporter to the US, Manufactureraccessdata.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
October 8, 2020K201483Impression MaterialELWSubstantially EquivalentZhengzhou Huaer Electro Optics Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 8, 2020. 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.