Zhengzhou Huaer Electro-Optics Technology Co., Ltd.
Registered establishment in Zhengzhou, Henan, China. 21 device types, 1 clearance.
Zhengzhou Huaer Electro-Optics Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Toothbrush, Manual, Scaler, Periodontic and 19 other device types. Its earliest product listing with the FDA dates from 2012.
21device types registered with the FDA
1510(k) clearance
Registration
| Registered name | ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008648418 |
| FEI number | 3008648418 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Zhengzhou |
|---|---|
| Province | Henan |
| Address | Room 301, 3rd Floor, Building 2, No. 52, Hongsong Road, High-tech Industrial Development Zone |
| Postal code | 450001 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Camera, Surgical And Accessories | Class 1 | Intra Oral Camera | 2022 | 22 |
| Cleaner, Ultrasonic, Medical Instrument | Class 1 | ultrasonic cleaner | 2022 | 48 |
| Cleanser, Denture, Over The Counter | Class 1 | Cleanser, Denture, Denture Cleanser, denture cleaning tablets | 2021 | 34 |
| Coating, Denture Hydrophilic, Resin | Class 2 | resin material | 2022 | 1 |
| Container, Specimen, Non-Sterile | Class 1 | Mouth tray box | 2019 | 115 |
| Eraser, Dental Stain | Class 1 | Hyaluronic Gum Serum, Mouth Tray, Gingival barrier/Gum protector, Charcoal Teeth Whitening Powder, Charcoal teeth whitening strips, charcoal foam toothpaste,, Coconut oil teeth whitening pulling, bamboo toothbrushes, teeth whitening strips, desentitization gel,, gingival barriel, gum protector and 12 more | 2015 | 33 |
| Guide, Needle, Surgical | Class 1 | Micro needling therapy system | 2024 | 32 |
| Heat Source For Bleaching Teeth | Class 1 | Heat Source for Bleaching Teeth, Teeth Whitening lamp/Machine/Light | 2012 | 56 |
| Instruments, Dental Hand | Class 1 | Outie tool | 2024 | 64 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Red LED Light Therapy Device | 2024 | 235 |
| Material, Impression | Class 2 | Impression Material, Elastomeric Impression Material, Light Body VPS Addition Silicone Elastomeric Impression Material, Impression material kit | 2020 | 6 |
| Material, Impression Tray, Resin | Class 1 | 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 | 2021 | 41 |
| Orthosis, Moldable, Supportive, Skin Protective | Class 1 | Oxygen Dome Facial Machine | 2022 | 10 |
| Plaque Disclosing Kit | Class 2 | Dental Plaque Indicator | 2022 | 3 |
| Pusher, Band, Orthodontic | Class 1 | Chewies | 2024 | 12 |
| Retractor, All Types | Class 1 | Cheek Retractor | 2019 | 45 |
| Scaler, Periodontic | Class 1 | Teeth Cleaning Kit | 2023 | 34 |
| Toothbrush, Manual | Class 1 | Toothbrush | 2024 | 244 |
| Toothbrush, Powered | Class 1 | Electric toothbrush | 2022 | 191 |
| Tray, Impression, Preformed | Class 1 | Preformed impression tray, Plastic impression tray, impression tray | 2019 | 73 |
| Unit, Oral Irrigation | Class 1 | water flosser | 2022 | 128 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K201483 | 2020-10-08 | ELW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Factory area | 5000 m2 |
| Main products | Teeth whitening devices, Oxygen concentrators, Beauty skincare |
| Certifications | National High-Tech Enterprise, Class II Medical Device, GMP |
| Export markets | 110+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.