FDA Registration
Active
🇨🇳 China
Jiangxi Ushine Bright Medical Co., Ltd.
Reg #: 3023895623
·
FEI: 3023895623
·
Expires 2026
Products
17
Proprietary Names
26
Establishment Types
3
Classifications
17
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Registration Details
- Registration Name
- Jiangxi Ushine Bright Medical Co., Ltd.
- Registration Number
- 3023895623
- FEI Number
- 3023895623
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Makou Industrial Park, Yongxiu County
- City
- Jiujiang City Jiangxi
- Country
- CN
Owner / Operator
- Firm Name
- Jiangxi Ushine Bright Medical Co., Ltd.
- Operator Number
- 10089595
- Address
- Makou industrial park, Yongxiu County
- City
- Jiujiang City
- State
- Jiangxi
- Postal Code
- 330300
- Country
- CN
- Correspondent
- Junyuan Qin
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dam, Rubber | EIE | Class 1 | Dental | No | 2023-12-20 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2023-12-20 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2023-12-20 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2023-12-20 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2023-12-20 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2023-12-20 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2023-12-20 |
| Floss, Dental | JES | Class 1 | Dental | No | 2023-12-20 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-09-13 |
| Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | KOT | Class 1 | Dental | No | 2023-12-20 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2023-12-20 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2023-12-20 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2023-12-20 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2023-12-20 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2023-12-20 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2023-12-20 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-12-20 |
Proprietary Names
Gum Dam/ Gum Protetcor/Gingival Barrier
Plastic Glasses
Stop Snoring Chin Strap/Anti Snore Jaw Supporter/Anti Snore Belt/ Chin Strap Belt
Electric Toothbrush/ Sonic Toothbrush/ Electric Led Toothbrush/ Sonic Led Toothbrush
Cheek Retractor/Mouth Opener
Denture Cleansing Tablet/Aligner Cleaner
Teeth Protector
Thermoplastic Mouth Tray/ Mouth Piece/ Teeth Whitening Mouth Tray/ Foam Strip Mouth Tray/ Gel Prefilled Mouth Tray
Dental Floss
Oral irrigator
Denture Adhesive Cream; Denture Adhesive Powder
Anti Snoring Mouth Tray/Anti Snore Mouth Tray/ Anti Snore Kit/ Stop Snoring Device
Dental Impression Material / Silicone Impression Material
Teeth Whitening Light/ Teeth whitening Led Light/ Portable Teeth Whitening Light/ Teeth Whitening Lamp/
Teeth Whitening Mouth Tray Led Light/ Teeth Whitening Mini Light 1/5 LED; Teeth Whitening Light 8/16/24/32 LED
Disinfectant box for denture, Toothbrush sterilization box
Teeth Wipes/ Brush Ups/ Oral Brush Ups/ Bamboo toothbrush/ Plastic Toothbrush/ Bamboo toothbrush
BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum
Double Barrel Gel/ Double Barrel Syringe Gel/ Teeth Remineralization Gel/ Teeth Desensitizing Gel/ Teeth Whitening Kit/
Oral Spray
Teeth Whitening Home Kit/ Teeth Whitening LED kit/ Teeth Whitening Strips/ Teeth Whitening Dry Strips/
Teeth Whitening Pen/ Teeth Whitening Gel Pen/ Teeth Whitening Gel 3ml/ 5ml/ 10ml/ V34 Colour Corrector/
V34 Colour Corrector Foam/ NHpro Enamel Care/ HA5 Hyaluronic Serum/ Tooth Gloss
Charcoal Teeth Whitening Strips/ V34 Teeth Whitening Strips/ Teeth Whitening Essence/ Teeth Whitening Foam/
Charcoal Teeth Whitening Powder/ Teeth Whitening Powder/ Coconut Oil Pulling/ Coconut Oil Sachet/ Dual Barrel Gel/
Vitamin E Swab
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)